(269 days)
Proov test is intended for the detection of pregnanediol glucuronide (PdG, the major urine metabolite of progesterone) in urine and can be used as an aid for confirmation of ovulation.
The Proov Test is intended for measuring pregnanediol glucuronide (PdG) in first morning urine during the luteal phase of the monthly female reproductive cvcle. The Proov Test is a disposable lateral flow test strip, consisting of a test area and control area. The urine sample is applied to the strip by dipping. The sample moves by lateral flow into the test area, and then the control area. The test area has PdG-specific reagents impregnated on it to detect the present of PdG in the urine. The control area has antibodies impregnated to be used as internal control for proper assay function. The test strip is intended for use outside the body (in vitro diagnostic use) and provides qualitative results with a single red line indicating a positive result for PdG and two red lines indicating a negative result for PdG in urine. Women can use Proov Test at multiple times during their menstrual cycle to confirm ovulation.
The provided document is a 510(k) Premarket Notification from the U.S. FDA for the Proov Test, a device intended for the detection of pregnanediol glucuronide (PdG) in urine as an aid for confirmation of ovulation. The document details the analytical and clinical studies conducted to demonstrate the device's performance characteristics.
Here’s a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria & Reported Device Performance
The document doesn't explicitly present a formal "acceptance criteria" table with pre-defined performance thresholds alongside the results. However, the performance studies implicitly define the expected outcomes for the device to be considered acceptable. I will infer the acceptance criteria from the context of "good performance" for this type of diagnostic test.
| Performance Characteristic | Implicit Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Analytical Precision (PdG detection) | All negative samples should be negative; all highly positive samples should be positive. Samples near the cutoff should show a mix of positive/negative results consistent with the cutoff. | Precision Study:- 0 ug/mL (100% below cutoff): 0 positive / 90 negative (100% correctly negative)- 2.5 ug/mL (50% below cutoff): 0 positive / 90 negative (100% correctly negative)- 3.75 ug/mL (25% below cutoff): 0 positive / 90 negative (100% correctly negative)- 5 ug/mL (Cut-Off): 41 positive / 49 negative (Mix of results as expected at cutoff)- 6.25 ug/mL (25% above cutoff): 90 positive / 0 negative (100% correctly positive)- 7.5 ug/mL (50% above cutoff): 90 positive / 0 negative (100% correctly positive)Conclusion: Cut-off value of 5 ug/mL is verified. |
| Detection Limit | Clearly defined and consistently detected. | 5 ug/mL PdG (verified by precision study above) |
| Interference/Cross Reactivity | No significant interference from common substances at physiological/pathological concentrations. | No interference observed from 20 tested substances (e.g., LH, HCG, Progesterone, glucose, acetaminophen, etc.) at specified concentrations. |
| Effect of Urine Specific Gravity & pH | Consistent results across a range of normal urine specific gravity and pH values. | All positive samples above cutoff remained positive, and all negative samples remained negative across pH 4.25-9 and specific gravity 1.000-1.025. |
| Hook Effect | No hook effect observed at high analyte concentrations. | No hook effect observed up to 1 mg/mL PdG. |
| Comparison to Reference Method (Clinical Correlation) | High concordance with a validated reference method (EIA procedure). Minor discordances, particularly near the cutoff, are expected. | Comparison Study (94 urine samples):- Viewer A: 90.4% concordance (85/94 matched ELISA classification)- Viewer B: 92.6% concordance (87/94 matched ELISA classification)- Viewer C: 95.7% concordance (90/94 matched ELISA classification)Discordant results primarily near the ELISA cutoff (e.g., ELISA 4.4 ug/mL read positive by Viewer A, ELISA 5.2 ug/mL read negative by Viewers B & C). |
| Lay User Performance (Ability to read and interpret) | High percentage of lay users correctly identify positive/negative results and find instructions easy to understand. | Lay User Study (101 lay persons; 121 total samples):- 100% correct interpretation for all tested concentrations (1.25, 2.5, 3.75 ug/mL negative; 6.25, 7.5, 8.75 ug/mL positive). (Actual number of correct interpretations: 121 of 121 samples).- 92% of lay users indicated instructions were "easy" or "very easy". |
2. Sample Sizes and Data Provenance
- Test Set (Analytical & Clinical):
- Precision Studies: 90 replicates per PdG concentration (total 540 replicates in the table).
- Interference/Cross Reactivity: Samples (negative male urine and spiked male urine) tested with three batches of the device for each of the 20 substances. Specific number of samples not explicitly stated beyond "samples."
- Specific Gravity & pH: "Negative urine samples" and "urine spiked with PdG 25% above cut-off levels" tested with three batches of the device. Specific number of samples not explicitly stated.
- Hook Effect: "Negative urine samples were spiked with PdG at concentrations of ranging from 50 ug/ml to 1 mg/ml." Tested with three lots. Specific number of samples not explicitly stated.
- Comparison Studies: 94 urine samples collected from "apparently healthy female individuals."
- Lay User Study: 101 lay persons; 121 blind-labeled samples (each participant received 1 or 2 samples).
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective in nature, as they involve testing samples (either prepared or collected) with the device and assessing performance.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Analytical Ground Truth (e.g., for precision, interference): Established by the study design (known concentrations of spiked PdG, known interfering substances). No external "experts" were used to establish this ground truth in the sense of clinical interpretation.
- Comparison Study Ground Truth: A "validated PDG EIA procedure" was used as the reference method (ground truth) for the 94 urine samples. No information is provided regarding the qualifications of the personnel who performed the EIA procedure or established its "validity."
- Lay User Study Ground Truth: The ground truth for the lay user study was the known spiked concentration of PdG in the simulated urine samples (e.g., 1.25 ug/mL was negative, 6.25 ug/mL was positive).
4. Adjudication Method for the Test Set
- Comparison Study: The Proov Test results were read by "three different technicians." It does not explicitly state an adjudication method (e.g., 2+1, majority vote) among these technicians to arrive at a single "Proov Test result" for comparison. The table shows separate results for Viewer A, Viewer B, and Viewer C, implying individual readings were recorded and compared to the ELISA. Discordant results are listed individually for each viewer.
- Lay User Study: Lay users read their own results. The "correctness" was determined by comparison to the known spiked concentrations. No "adjudication" between lay users occurred; their individual reading accuracy was assessed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a formal MRMC study was not described in the typical sense of comparing human readers with AI assistance vs. without AI assistance.
- The comparison study involved three technicians reading the Proov test, and their individual results were compared to a reference method (ELISA). This is a multi-reader study for the device interpretation, but it does not evaluate the improvement of human readers using AI, as the Proov Test itself is a rapid diagnostic kit, not an AI-powered diagnostic.
- The Lay User study also involved multiple readers (the lay persons), but it focused on their ability to interpret the device without any assistance (AI or otherwise) beyond the package insert.
6. Standalone Performance (Algorithm Only)
- Not applicable. The Proov Test is a visually read lateral flow assay, not an algorithm or AI-driven device. Its performance is inherent to the chemical reactions on the strip and how it presents results for human interpretation. Therefore, there is no "algorithm only" performance to describe.
7. Type of Ground Truth Used
- Analytical Studies: Ground truth was established by known concentrations of PdG in samples (spiked male urine or simulated urine) and the presence/absence of specific interferents.
- Comparison Study: Ground truth was established by a validated PDG EIA procedure, used as a reference method for the collected urine samples.
- Lay User Study: Ground truth was established by known spiked concentrations of PdG in prepared simulated urine samples.
8. Sample Size for the Training Set
- Not applicable. This is a diagnostic kit, not a machine learning or AI model that requires a "training set" in the computational sense. The device's performance is based on its chemical and biological components.
9. How Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this type of device. The "training" for the device's development would be analogous to traditional R&D and validation processes for chemical assays, where performance is optimized based on laboratory testing and analytical validation, not by training an algorithm on a dataset with established ground truth.
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February 27, 2020
MFB Fertility, Inc. % Mary Vater Quality & Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, VT 05738
Re: K191462
Trade/Device Name: Proov Test Regulation Number: 21 CFR 862.1620 Regulation Name: Progesterone Test System Regulatory Class: Class I, meets the limitation to the exemption 21 CFR 862.9(a) and 862.9(b) Product Code: QKE Dated: January 22, 2020 Received: January 23, 2020
Dear Mary Vater:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191462
Device Name Proov Test
Indications for Use (Describe)
Proov test is intended for the detection of pregnanediol glucuronide (PdG, the major urine metabolite of progesterone) in urine and can be used as an aid for confirmation of ovulation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
l. Submitter
MFB Fertility Inc. 1630A 30th Street PMB 143 Boulder, CO 80301 Tel: +1-720-507-6699 Sponsor Person: Amy Beckely Email: Amy@mfbfertility.com Date Prepared: February 24, 2020
II. Contact
Mary Vater, Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, Vermont, 05738, USA Tel: +1.523.6988 Email: mary@fdaecopy.com
lll. Device
| 510(k) Number: | K191462 |
|---|---|
| Name of Device: | Proov Test |
| Classification Name: | Progesterone Test System |
| Regulation: | 21 CFR §862.1620 |
| Regulatory Class: | Class I |
| Classification Code: | QKE |
IV. Predicate Device
| 510(k) Number: | K040923 |
|---|---|
| Device Name: | IBL Progesterone LIA Test |
| Manufacturer: | IBL GMBH |
> Device Description
The Proov Test is intended for measuring pregnanediol glucuronide (PdG) in first morning urine during the luteal phase of the monthly female reproductive cvcle. The Proov Test is a disposable lateral flow test strip, consisting of a test area and control area. The urine sample is applied to the strip by dipping. The sample moves by lateral flow into the test area, and then the control area. The test area has PdG-specific reagents impregnated on it to detect the present of PdG in the urine. The control area has antibodies impregnated to be used as internal control for proper assay function. The test strip is intended for use outside the body (in vitro diagnostic use) and provides qualitative results with a single red line indicating a positive result for PdG and two red lines indicating a negative result for PdG in urine. Women can use Proov Test at multiple times during their menstrual cycle to confirm ovulation.
VI. Indications for Use
Proov test is intended for the detection of pregnanediol glucuronide (PdG, the major urine metabolite of progesterone) in urine and can be used as an aid for confirmation of ovulation.
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VII. Comparison of Technological Characteristics with the Predicate Device
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
- Indications for Use – The predicate and subject devices intended for the purposes of ovulation confirmation.
- Materials The Proov Test is an IVD made of materials commonly found in lateral flow ● IVD devices. Biocompatibility is not of concern for IVD devices.
- Design The subject device has the same technological characteristics as the use of the ● competition principle and use of antigen to compete for the binding site of the targeted antibody.
- Energy Source The subject device is an analog IVD device and therefore no energy . source is needed.
- Performance Testing Analytical testing was performed on the subject device to ● demonstrate that the Proov Test accurately and reproducibly measures PdG.
- . Clinical Testing - Clinical testing was performed on the subject device to demonstrate that the Proov Test accurately confirms ovulation and that users are able to reach accurate conclusions when compared to expert analysis of the test results.
| Proov Test (Subject Device) | IBL Progesterone LIATest | Comments onSubstantial Equivalence | ||
|---|---|---|---|---|
| Indicationsfor Use | Proov test is intended for thedetection of pregnanediolglucuronide (PDG, the majorurine metabolite ofprogesterone) in urine and canbe used as an aid forconfirmation of ovulation. | Luminescenceimmunoassay for the invitro diagnosticquantitative measurementof active freeprogesterone (a femalehormone) in saliva.Measurements obtainedby this device may beused in the diagnosis andtreatment of disorders ofthe ovaries and can beused as an aid forconfirmation of ovulation. | The devices are both usedfor the confirmation ofovulation. | |
| Materials | Antibody and AntigenNitrocellulose MembraneColloidal Gold Conjugate PadSample Pad | - Microtiter Platecoated with rabbitanti-mouse antibody- ProgesteroneAntiserum (mouseanti-progesteroneantibody)- Standards A-G (0,20, 25, 50, 100, 300,and 1000 pg/mL);progesterone inbuffer with BSA andstabilizers- Controls Level I andII | The Proov Test is an IVDmade of materialscommonly found inlateral flow IVD devices.Biocompatibility is not ofconcern for IVD devices. | |
| Design | In vitro diagnostic deviceconsisting of disposablelateral flow test strip,consisting of a test area andcontrol area. The urine sampleis applied to the strip bydipping. The sample moves bylateral flow into the test area,and then the control area. Thetest area has PdG-specificreagents impregnated on it todetect the presence ofhormone metabolites in urine.The test strip is intended foruse outside of the body, andprovides qualitative resultswith a single red lineindicating a positive result forPdG and two red linesindicating a negative result forPdG in urine. Presence of PdGconfirms that ovulation hasoccurred. | Assay Buffer (Tris buffer with BSA and stabilizers) Enzyme Conjugate (alkaline phosphate [calf] conjugate with stabilizers) Chemiluminescence Reagent AP (acridan based substrate) Wash Buffer (Tris buffer with Tween and stabilizer) Adhesive Foil | Device is an ELISA basedon the competition assayprinciple. An unknownamount of antigen presentin the sample and a fixedamount of enzyme labeledantigen compete for thebinding sites of theantibodies/antigens coatedonto the wells. Results ofsamples can bedetermined directly usingthe standard curve. | The subject device issimilar to the predicatedevice with use of thecompetition principle anduse of antigen to competefor the binding site of thetargeted antibody. |
| Analyte | Pregnanediol Glucuronide(PdG) | Progesterone | The predicate measuresprogesterone and thesubject device measures aprogesterone metabolite,PdG. | |
| Method | Lateral flowImmunoassay/competitionprinciple | ELISAImmunoassay/competitionprinciple | Immunoassay/competitionprinciple, thereforeequivalent. | |
| Specimen | Urine | Saliva | Both are clinically validspecimens for targetedanalyte. | |
| IntendedPopulation | For over-the-counter andprescription uses | Prescription use | Proov has beensuccessfully validatedwith lay-users. | |
| Reading | Visual, colloidal gold | Luminescence | Subject device is | |
| Indicator | qualitative and thepredicate isquantitative.Comparison of Proovvs. ELISA method tosupport equivalence. | |||
| PerformanceTesting | Precision/ReproducibilityStudyTraceability ControlDetection LimitAnalyticalSpecificity/Interference/Cross-ReactivitySpecific Gravity and pHHook EffectComparison StudyLay User Study | Precision/ReproducibilityLinearityTraceability ControlDetection LimitAnalytical SpecificityComparison Studies | The testing conductedwas similar for boththe predicate andsubject devices withthe exception that thepredicate devicerequired linearitytesting, which is notapplicable to a lateralflow assay. |
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VIII. Performance Characteristics
Analytical Performance
- a. Precision
Precision studies were conducted with male urine samples spiked with six (6) concentrations of PdG: -100%, -50%, -25%, cutoff, +25%, and +50% of the threshold were run in replicates of ten (10) each within one assay run to determine within-lot precision. Between lot reproducibility was determined by replicate measurements of ten (10) different urine samples in three (3) different lots. Between technician reproducibility was determined in ten (10) different test runs of three (3) different technicians. The results obtained are summarized in the following table
| PDGConcentration | -100%(0 ug/mL) | -50%(2.5 ug/mL) | -25%(3.75 ug/mL) | Cut-Off(5 ug/mL) | 50%(6.25 ug/mL) | 75%(7.5 ug/mL) |
|---|---|---|---|---|---|---|
| Positive Results/Negative Results | 0 + / 90 - | 0 + / 90 - | 0 + / 90 - | 41 + / 49 - | 90 + / 0 - | 90 + / 0 - |
The cut-off value of 5 ug/mL is verified for the device.
-
b. Linearity
Not applicable, these are visually read devices. -
Traceability C.
The tests calibrated against PdG standards. -
Shelf Life d.
The devices are stable at 4-30℃ (39-86F) for 24 months based on the accelerated stability study at 42°C. -
Detection Limit (sensitivity) e. 5 ug/ml PdG
-
Interference/Cross Reactivity f. Potential interfering substances found in human urine of physiological or pathological conditions were added to negative male urine and male urine spiked with PdG 25% above the cut-off level.
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| Substances | Concentration |
|---|---|
| LH | 600 mIU/ml |
| HCG | 1000 mIU/ml |
| Progesterone | 100 ng/ml |
| Pregnanediol | 60 ug/ml |
| Estone-3-Glucuronide | 600 ng/ml |
| Acetaminophen | 20 mg/dl |
| Ascorbic Acid | 20 mg/dl |
| Caffeine | 20 mg/dl |
| Glucose | 2000 mg/dl |
| Ampicillin | 20 mg/dl |
| Ketone | 1% |
| Acetylsalicylic Acid | 20 mg/dl |
| Atropine | 20 mg/dl |
| Gentisic Acid | 20 mg/dl |
| Hemoglobin | 500 mg/dl |
| Tetracycline | 20 mg/dl |
| Nitrite Positive | 1% |
| Phenothiazine | 20 mg/dl |
| Ethanol | 1% |
| Albumin | 100 mg/dl |
These urine samples were tested using three batches of the device. The following compounds showed no interference at the concentrations shown as summarized in the following table.
Effect of Urine Specific Gravity and Urine pH g.
To investigate the effect of urine specific gravity and urine pH, negative urine samples and urine spiked with PdG 25% above cut-off levels with a 1.000 to 1.025 specific gravity or urine samples with pH 4.25 to 9 were used. These samples were tested using three batches of device. Results were all positive for samples above the +25% cut-off and all negative for negative samples.
h. Hook Effect.
Negative urine samples were spiked with PdG at concentrations of ranging from 50 ug/ml to 1 mg/ml. Three lots of the devices were tested. The results demonstrated that no hook effect was observed at PdG concentrations up to 1 mg/ml
i. Comparison studies:
The method comparison studies for the Proov Test were compared to a validated PDG EIA procedure. The PDG content from 94 urine samples collected from apparently healthy females individuals were assessed by both methods. All samples were blind- labeled and Proov Tests results were read by three different technicians. Proov results were compared to PDG ELISA results. Results are presented below.
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| Proov Test | Low negative by ELISA (less than -50%) | Near Cutoff Negative by ELISA (Between - 50% and cut-off) | Near Cutoff Negative by ELISA (Between cut-off and + 50%) | High Positive by ELISA (greater than +50%) | |
|---|---|---|---|---|---|
| Viewer A | Positive | 0 | 4 | 13 | 18 |
| Negative | 48 | 11 | 0 | 0 | |
| Viewer B | Positive | 0 | 1 | 13 | 18 |
| Negative | 48 | 14 | 1 | 0 | |
| Viewer C | Positive | 0 | 0 | 12 | 18 |
| Negative | 48 | 15 | 1 | 0 |
Discordant Results
| Viewer | Sample # | ELISA Result | Viewer Results |
|---|---|---|---|
| Viewer A | 12 | 4.4 | positive |
| Viewer A | 41 | 4.6 | positive |
| Viewer A | 66 | 4.7 | positive |
| Viewer A | 16 | 4.8 | positive |
| Viewer B | 16 | 4.8 | positive |
| Viewer B | 46 | 5.2 | negative |
| Viewer C | 46 | 5.2 | negative |
i. Lay User Study:
A lay user study was performed at three intended user sites with 101 lay persons testing the devices. They had diverse educational and professional backgrounds and were all women ranged in age from 18 to 65 years. Urine samples were prepared at the following concentrations; +/- 75%, +/-50%, +/-25% of the cutoff by spiking PdG into simulated urine. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 or 2 blind labeled sample and 1 or 2 devices. The results demonstrate that lay women can correctly read Proov results over 99% of the time (121 of the 121 samples).
| PDG conc | # neg | # pos | % correctlyinterpreted |
|---|---|---|---|
| 1.25 | 20 | 0 | 100 |
| 2.5 | 20 | 0 | 100 |
| 3.75 | 21 | 0 | 100 |
| 6.25 | 0 | 20 | 100 |
| 7.5 | 0 | 20 | 100 |
| 8.75 | 0 | 20 | 100 |
Lay-users were also given surveys on the ease of understanding the package insert instructions. 92% of lay users indicated that the device instructions and testing were easy or very easy. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 8.
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IX. Conclusions
The overall performance data in this submission supports that the MFB Fertility, Inc. Proov Test is substantially equivalent to the predicate device.
§ 862.1620 Progesterone test system.
(a)
Identification. A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.