AmnioTest™ — Sterile Amniotic Fluid Sampler with Nitrazine pH Indicator.
FDA 510(k)-cleared (K914419) sterile sampling swab impregnated with nitrazine yellow. The indicator shifts color with the pH of the specimen on the swab. Color reference card included. Up to 3-year shelf life. ~$2.70/swab. Rx only — for professional healthcare use.
510(k)
K914419
Shelf Life
3 yrs
Per Swab
~$2.70
FDA 510(k) Cleared
Class I sterile amniotic fluid sampler (product code HIO, 21 CFR 884.1550). Cleared 1993; Pro-Lab, Inc.
Shelf Life
Up to 3 years. Order in volume without waste. Simplifies L&D inventory management.
Per Swab
PL.901 direct pricing: $269.50 / 100 swabs. A low-cost sterile sampling option for L&D and OB/GYN units.
Why AmnioTest
The Cleanest Way to Do Bedside pH on Amniotic Fluid
For decades, L&D units have done bedside nitrazine pH the same way: tear a strip off a roll of pH paper, touch it to the swab or speculum, eyeball the color. It works — but a roll of nitrazine paper isn't sterile, isn't traceable, isn't individually packaged, and isn't FDA-cleared as anything other than industrial pH paper. AmnioTest™ is the sterile, single-use, individually packed alternative — a sampling swab impregnated with the same nitrazine pH indicator, gamma-irradiated and sealed in its own foil pouch, with a matched PL.902 color reference card included. One swab per pouch, opened at the bedside, used once, discarded. No cross-contamination between patients. No torn-off strips floating around the cart. No "where did this paper come from" audit question on the next inspection.
Five reasons to standardize on AmnioTest
Sterile, single-use, individually packaged
The only nitrazine pH sampling presentation that meets the sterility expectations of an L&D collection workflow. Open at the bedside, use once, document, discard. No shared roll. No cross-contamination. No audit risk.
FDA-cleared as a medical device
510(k) K914419, Class I sterile amniotic fluid sampler, product code HIO under 21 CFR 884.1550. Cleared in 1993, continuously manufactured by Pro-Lab. Your compliance team can trace the device classification end-to-end.
Color reference card included (PL.902)
Same nitrazine color standard the swab is measured against. No guessing, no comparing against a chart printed on the box. The PL.902 card is documented in the IFU and matches the swab's indicator chemistry.
Complete QC program available
PL.910 through PL.915 buffer solutions (pH 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, $64.49 each) give the lab a verifiable QC trail for the nitrazine indicator response across its full clinical range. No improvisation with home-brewed pH solutions.
The economics work the first day you bill
At $2.70/swab and an $8–10 CLFS reimbursement on CPT 83986 (or $58–65 when paired with CPT 84112), a 100-swab box pays for itself by case 27 and runs ~3 years on the shelf without cold-chain logistics. See the billing breakdown below.
AmnioTest vs. Generic Nitrazine pH Paper — side by side
Device class, sterility, packaging, shelf life, and cost — compared.
| Feature | AmnioTest™ (PL.901) | Generic Nitrazine Paper |
|---|---|---|
| Device Class & Clearance | FDA 510(k) K914419 · Class I sampler (HIO) | Varies by supplier |
| Sterile, Single-Use, Individually Packed | check_circle Yes | Typically no |
| Format | Impregnated swab — vaginal-vault sampling | Paper strip — surface contact |
| pH Color Reference Card | check_circle Included (PL.902) | Not included |
| QC Buffer Kit Available | check_circle PL.910–915 (pH 5.0–7.5) | Not available |
| Shelf Life | Up to 3 years | Varies |
| Direct Price per Swab | ~$2.70 | ~$0.05–0.10 |
AmnioTest™ is cleared by FDA as a Class I sterile amniotic fluid sampler (510(k) K914419, product code HIO, 21 CFR 884.1550). It is not cleared as an in-vitro diagnostic for the diagnosis of premature rupture of membranes. The nitrazine pH color indicator is a property of the swab; clinical interpretation requires the treating healthcare professional, supported by patient history, physical examination, and additional diagnostic testing as indicated. Vaginal pH can be elevated by blood, bacterial vaginosis, semen, urine, and alkaline antiseptics.
What AmnioTest isn't — and why that's a feature, not a bug
AmnioTest is not an in-vitro diagnostic. It does not claim to diagnose PROM. It does not replace the PAMG-1 immunoassay, clinical judgment, or patient history and exam. The K914419 clearance covers exactly what AmnioTest does: collect a sample, indicate pH, and provide a reference for interpretation.
- For the billing lead: clean coding (CPT 83986 for the lab pH determination on the specimen) and zero exposure to claims that the device is doing more than its 510(k) covers.
- For the medical director: clinical interpretation stays with the treating clinician.
- For the procurement lead: a $2.70 single-use supply with a multi-year shelf life and a published reimbursement code attached to the workflow it supports.
Lab Workflow Fit
What's Billable, What's Not — and How AmnioTest Fits
AmnioTest™ is FDA-cleared as a Class I sterile amniotic fluid sampler (510(k) K914419, product code HIO, 21 CFR 884.1550) — a sampling device with a built-in nitrazine pH indicator strip. The sampler itself is a supply, not a billable test — same as standard nitrazine pH paper, a sterile speculum, or any collection swab. What a CLIA-certified laboratory bills, when it performs and reports a pH determination on the collected specimen, is the laboratory test code CPT 83986 (pH, body fluid) — categorized moderate complexity, not CLIA-waived.
What's billable vs. what's not
Devices are supplies, not billable tests. The lab bills the test it performs and reports — not the swab, paper, or cassette it used. AmnioTest is the device that lets a CLIA-certified lab perform CPT 83986 (pH, body fluid) on the collected specimen.
| Item | Billable? | Code & reimbursement | Lab cost / test | Margin / test |
|---|---|---|---|---|
| Lab pH determination on the specimen using AmnioTest | check_circle Yes — the test is billable, not the device | CPT 83986 — pH, body fluid Medicare CLFS ~$8–$10 |
~$2.70 (AmnioTest swab) | ~$5.30–$7.30 / test |
| PAMG-1 immunoassay using AmniSure® cassette (or equivalent IVD) | check_circle Yes — same principle, different test & code | CPT 84112 — cervicovaginal fluid PAMG-1 Medicare CLFS ~$50–$55 |
~$45–$50 (cassette, typical distributor — verify locally) | ~$5–$10 / test |
Same margin, ~1/17th the inventory cost.
An AmnioTest-driven CPT 83986 returns roughly $5–$7 gross margin per test. An AmniSure®-driven CPT 84112 returns roughly $5–$10 gross margin per test at typical hospital distributor pricing. The lab walks away with comparable per-test gross margin in both workflows — but AmnioTest does it at ~1/17th the inventory acquisition cost ($2.70 vs. $45+) and with a shelf life up to 3 years. A lab that runs both on the same encounter (when clinically warranted) stacks the margins: ~$10–$17 combined per case.
AmniSure® cassette cost is an approximate range based on typical hospital distributor pricing — varies by GPO and volume. Confirm the lab's actual cost with the distributor or purchasing lead. Medicare CLFS rates are approximate national figures and change annually.
Side-by-side workflow comparison
| AmnioTest workflow | AmniSure®-only workflow | |
|---|---|---|
| Collection device | AmnioTest sterile sampler (Class I, K914419) — ~$2.70/swab supply | Collection swab / cassette per AmniSure IFU |
| At point of collection | Built-in nitrazine pH indicator strip — pH observation documented in the chart | No pH read — IVD-only workflow |
| Lab test (if lab performs pH determination) | CPT 83986 — pH, body fluid · Medicare ~$8–10 | (no pH test billed) |
| Lab test (if lab runs the PAMG-1 IVD) | Optional add-on when clinically warranted: CPT 84112 · Medicare ~$50–55 | CPT 84112 · Medicare ~$50–55 |
| Acquisition cost per case | ~$2.70 (swab) | (refer to current Qiagen/Hologic distributor pricing) |
| Lab reimbursement when billed | $8–10 (83986 alone) up to ~$58–65 (83986 + 84112 when both performed) | $50–55 (84112) |
Many institutions use both in their L&D workflow: AmnioTest as the sterile collection sampler that captures and documents a nitrazine pH observation at the bedside, with the PAMG-1 IVD ordered separately at the laboratory's discretion when the clinical picture calls for it. The two CPT codes describe different tests — 83986 is a manual pH determination on a body-fluid specimen, 84112 is a PAMG-1 immunoassay — and they are not interchangeable. They are also not mutually exclusive; a CLIA-certified lab can bill both on the same encounter when both tests are actually performed, ordered, and documented per its own policies and payor mix.
Regulatory note. AmnioTest™ is FDA-cleared as a Class I sterile amniotic fluid sampler (510(k) K914419, product code HIO, 21 CFR 884.1550). It is a sampling device, not an in-vitro diagnostic. CPT 83986 describes the laboratory pH determination as performed and reported by a CLIA-certified laboratory; the CLIA categorization (moderate complexity, not waived) applies to that laboratory determination, not to the sampler itself. CPT 84112 describes the PAMG-1 immunoassay run by the laboratory using a separate IVD product (AmniSure® or equivalent). Clinical interpretation of any pH reading or assay result is the responsibility of the treating healthcare professional, supported by patient history, physical examination, and additional diagnostic testing as clinically indicated. Vaginal pH can be elevated by blood, bacterial vaginosis, semen, urine, and alkaline antiseptics. Medicare CLFS fee schedule rates change annually; figures are approximate national ranges — confirm current in-network reimbursement with your billing lead and payor mix.
Order Direct
All products ship from Pro-Lab Direct. Net 30 available for qualifying institutions.
AmnioTest™ — 100 Swabs
Standard unit supply of sterile sampling swabs for L&D and OB/GYN. ~$2.70/swab. Includes nitrazine pH color reference card.
AmnioTest™ — 20 Swabs
Trial pack or low-volume units. Same swabs as PL.901 — ideal for birth centers and smaller practices.
Nitrazine pH Color Reference Cards
Replacement or additional reference cards mapping nitrazine swab color to pH range. One card is included with every swab pack. For use by trained healthcare professionals only.
QC Buffer Solutions — PL.910–PL.915
pH-calibrated reference solutions for lot acceptance testing, staff training, and institutional QC of the nitrazine indicator. Each vial is 2.0 ml. Six pH values across the indicator's color-shift range.
Buffer pH 5.0
2.0 ml · QC buffer pH 5.0
Buffer pH 5.5
2.0 ml · QC buffer pH 5.5
Buffer pH 6.0
2.0 ml · QC buffer pH 6.0
Buffer pH 6.5
2.0 ml · QC buffer pH 6.5
Buffer pH 7.0
2.0 ml · QC buffer pH 7.0
Buffer pH 7.5
2.0 ml · QC buffer pH 7.5
A Sterile Sampling Swab with a Built-In pH Indicator.
AmnioTest™ is a sterile single-use swab impregnated with nitrazine yellow — a pH-sensitive dye. The device is cleared by FDA (510(k) K914419) as an amniotic fluid sampler. The nitrazine indicator changes color with the pH of the specimen on the swab; the included color reference card maps each observed color to its corresponding pH range (5.0–7.5).
The color information is provided as a property of the sampling swab itself. Clinical interpretation of any sampled specimen — including assessment of suspected premature rupture of membranes — is the responsibility of the treating healthcare professional, supported by patient history, physical examination, and other diagnostic testing as clinically indicated.
Nitrazine pH color shift: yellow ≈ pH 5.0 · olive-green ≈ pH 5.5–6.0 · blue-green ≈ pH 6.5 · navy ≈ pH 7.0–7.5. Map any observed color to the reference card.
— Nitrazine pH color reference (PL.902)
FDA 510(k) K914419
Cleared by FDA as a Class I amniotic fluid sampler (product code HIO, 21 CFR 884.1550). Manufactured by Pro-Lab, Inc.
Sterile & Single-Use
Individually packaged, sterile, single-use sampling swab. No instrumentation or processing required for collection.
Standardized pH Reference
Color reference card included (PL.902). Six pH-calibrated QC buffer solutions available (PL.910–915) for lot acceptance testing.
Up to 3-Year Shelf Life
Order in volume. Reduce expired inventory write-offs. Fits the variable-volume reality of L&D and OB/GYN triage.
A Sterile Sampler Sized to Every L&D Role
A Sterile Sampler That Belongs in Every L&D Cart.
AmnioTest™ is an FDA-cleared sterile sampling swab (K914419) designed for bedside use in L&D and OB triage. The nitrazine indicator gives an at-a-glance pH observation that you can document alongside your clinical findings. Diagnostic interpretation of PROM remains your clinical decision, supported by history, exam, and confirmatory testing as appropriate.
- check_circleFDA 510(k)-cleared sterile sampling swab (K914419)
- check_circleNitrazine pH indicator built into the swab — color reference card included
- check_circleSterile, individually packaged, single-use
- check_circleQC buffer solutions available for institutional lot verification (PL.910–915)
3-Step Bedside Use
- 1Per facility protocol and the device IFU, sample the vaginal vault with the sterile AmnioTest™ swab.
- 2Withdraw the swab and observe the nitrazine color.
- 3Map the observed color to the PL.902 reference card (pH 5.0–7.5) and document the observation in the patient record. Clinical interpretation is the responsibility of the treating professional.
Sterile Swab. Sample. Document Color.
AmnioTest™ fits the L&D nursing workflow: sterile, individually packaged, single-use swab; easy peel pack; included nitrazine pH color reference card for documentation. Clinical interpretation of the sample is the responsibility of the treating clinician.
- check_circleEasy peel opening — ready at the bedside
- check_circleSterile single-use sampling swab
- check_circleNitrazine pH color reference card — consistent color documentation across staff
- check_circleAvailable in 20-swab starter pack (PL.901-20) or 100-swab unit supply (PL.901)
Nitrazine pH Color Reference (PL.902)
Predictable Per-Swab Cost. Long Shelf Life. Direct Ordering.
AmnioTest™ PL.901 is $269.50 per 100 sterile sampling swabs — ~$2.70/swab — with an up-to-3-year shelf life. Direct ordering from Pro-Lab Direct simplifies vendor management for L&D and OB triage. Net 30 available for qualifying institutions.
- check_circle~$2.70 per sterile sampling swab
- check_circleUp to 3-year shelf life — order in volume without waste risk
- check_circle100-swab or 20-swab packs — right-size your order
- check_circleNet 30 available for qualifying institutions — request volume quote
Pricing at a Glance
Direct Pricing. 3-Year Shelf Life. Complete Product Line.
AmnioTest™ PL.901: $269.50 / 100 swabs (~$2.70/swab), direct. PL.901-20: $127.25 / 20 swabs for trial or low-volume units. With up to 3-year shelf life, order in larger quantities without expiry waste.
- check_circleFDA 510(k) K914419 — Class I sterile sampling swab
- check_circleCanadian manufactured — consistent quality
- check_circleNet 30 available for qualifying institutions
- check_circleComplete accessory line: PL.902 pH reference cards, PL.910–915 buffer solutions
Full Product Line Pricing
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Frequently Asked Questions
What is AmnioTest™?
AmnioTest™ is an FDA 510(k)-cleared sterile, single-use amniotic fluid sampling swab (510(k) K914419; product code HIO; 21 CFR 884.1550; Class I). The swab is impregnated with nitrazine yellow, a pH-sensitive dye. It is intended for use by trained healthcare professionals (Rx only).
What does the color shift on the swab represent?
Nitrazine yellow is a pH indicator. The color of the dye on the swab varies with the pH of the specimen in contact with it — yellow at acidic pH and shifting through olive-green, blue-green and dark blue as pH approaches neutral/alkaline. The included PL.902 reference card maps observed colors to pH ranges between 5.0 and 7.5.
Is AmnioTest™ cleared to diagnose premature rupture of membranes?
No. 510(k) K914419 clears AmnioTest™ as an amniotic fluid sampler (product code HIO). It is not cleared as an in-vitro diagnostic for the diagnosis of premature rupture of membranes. The clinical interpretation of any sampled specimen — including evaluation of suspected PROM — is the responsibility of the treating healthcare professional.
What is the pH range covered by the indicator?
The nitrazine indicator shifts color over the approximate pH range of 5.0 to 7.5. The PL.902 color reference card maps the full color gradient across this range; the PL.910–915 buffer solutions are calibrated at pH 5.0, 5.5, 6.0, 6.5, 7.0 and 7.5 for lot acceptance testing and staff training.
What can cause a higher-than-baseline pH observation?
Vaginal pH can be elevated by a number of factors, including amniotic fluid, blood, semen, urine, bacterial vaginosis, cervical mucus, and alkaline antiseptics. The nitrazine indicator does not distinguish between these sources. Clinical correlation by the treating professional is required for any pH observation.
Does AmnioTest™ require a speculum?
The device IFU does not require speculum placement for sampling. Follow facility protocol and the device Instructions for Use for sampling technique.
How long is the shelf life?
AmnioTest™ has a shelf life of up to 3 years when stored per manufacturer instructions.
What QC verification options are available?
Six pH-calibrated buffer solutions are available (PL.910 through PL.915, covering pH 5.0 to 7.5 in 0.5-unit increments). These allow facilities to verify nitrazine reactivity at each pH level — for lot acceptance testing, institutional QC protocols, and staff training.
What is the difference between PL.901 and PL.901-20?
Both contain the same AmnioTest™ swabs. PL.901 contains 100 swabs ($269.50) — suited for active L&D units. PL.901-20 contains 20 swabs ($127.25) — suited for trial evaluation, low-volume practices, birth centers, or individual physician offices.
Is AmnioTest™ CLIA-waived?
CLIA categorization applies to laboratory tests, not to sampling devices. AmnioTest™ is a Class I sterile amniotic fluid sampler (510(k) K914419). When a CLIA-certified laboratory performs and reports a pH determination on the collected specimen, that pH measurement is categorized moderate complexity, not CLIA-waived (CPT 83986, pH, body fluid). The right-fit customer is a laboratory holding a CLIA Certificate of Compliance or Accreditation covering moderate-complexity testing — including L&D POC labs with that certificate. See the Lab Workflow Fit section above for the full billing reference.
What CPT code applies?
When a CLIA-certified laboratory performs and reports a pH determination on the specimen collected with AmnioTest™, the pH measurement is billable under CPT 83986 (pH, body fluid). The CPT code applies to the laboratory pH determination, not to the sampler. Medicare CLAB rates change annually; confirm current in-network reimbursement with your billing lead and payor mix. See the Lab Workflow Fit section above for the regulatory note.
Ready to Stock AmnioTest™ in Your L&D Unit?
FDA 510(k) K914419 sterile sampling swab. Order direct at $269.50 / 100 swabs — or request volume pricing for your institution. Rx only.
Questions before ordering? Call 512-832-9145 or email us.