(269 days)
Not Found
No
The device description and performance studies focus on a simple lateral flow immunoassay with visual interpretation of results. There is no mention of image processing, AI, ML, or any data analysis beyond basic qualitative interpretation of lines on a test strip.
No.
The device is an in vitro diagnostic test for detecting a hormone metabolite in urine to aid in confirming ovulation, not to treat or prevent a disease or condition.
Yes
The device detects pregnanediol glucuronide (PdG) in urine to aid in the confirmation of ovulation. This process involves the detection and measurement of a biomarker to provide information about a physiological state, which aligns with the definition of a diagnostic device.
No
The device description clearly states it is a "disposable lateral flow test strip" which is a physical hardware component used for in vitro diagnostic testing. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "detection of pregnanediol glucuronide (PdG...in urine)" and is used "as an aid for confirmation of ovulation." This involves testing a sample taken from the body (urine) to provide information about a physiological state (ovulation).
- Device Description: The description clearly states the test strip is "intended for use outside the body (in vitro diagnostic use)." It also describes the mechanism of action which involves chemical reactions with the urine sample to produce a result.
- Regulatory Context: The intended user/care setting mentions "Over-The-Counter Use (21 CFR 801 Subpart C) and Prescription Use (Part 21 CFR 801 Subpart D)," which are regulations governing medical devices, including IVDs.
- Performance Studies: The document describes performance studies involving testing urine samples and comparing results to a validated method (PDG ELISA/EIA), which is typical for evaluating the performance of an IVD.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
QKE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found (The lay user study included women aged 18 to 65 years, but this is not explicitly stated as an indicated patient age range for the device itself.)
Intended User / Care Setting
For over-the-counter and prescription uses
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Analytical Performance:
- Precision: Studies conducted with male urine samples spiked with six concentrations of PdG: -100%, -50%, -25%, cutoff, +25%, and +50% of the threshold, run in replicates of ten each within one assay run. Between lot reproducibility determined by replicate measurements of ten different urine samples in three different lots. Between technician reproducibility determined in ten different test runs of three different technicians.
- Linearity: Not applicable, as devices are visually read.
- Traceability: Tests calibrated against PdG standards.
- Shelf Life: Stable at 4-30℃ (39-86F) for 24 months based on accelerated stability study at 42°C.
- Detection Limit (sensitivity): 5 ug/ml PdG
- Interference/Cross Reactivity: Potential interfering substances (LH, HCG, Progesterone, Pregnanediol, Estone-3-Glucuronide, Acetaminophen, Ascorbic Acid, Caffeine, Glucose, Ampicillin, Ketone, Acetylsalicylic Acid, Atropine, Gentisic Acid, Hemoglobin, Tetracycline, Nitrite Positive, Phenothiazine, Ethanol, Albumin) added to negative male urine and male urine spiked with PdG 25% above the cut-off level. Tested using three batches of the device. No interference observed.
- 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. Tested using three batches of device. All positive for samples above +25% cut-off and all negative for negative samples.
- Hook Effect: Negative urine samples spiked with PdG at concentrations ranging from 50 ug/ml to 1 mg/ml. Three lots of devices tested. No hook effect observed up to 1 mg/ml.
- Comparison studies: The PDG content from 94 urine samples collected from apparently healthy females individuals were assessed by both methods (Proov Test vs. validated PDG EIA procedure). Samples blind-labeled and Proov Tests results read by three different technicians. Results compared to PDG ELISA results.
- Lay User Study: Performed at three intended user sites with 101 lay persons with diverse educational and professional backgrounds, all women aged 18 to 65 years. Urine samples prepared at +/- 75%, +/-50%, +/-25% of the cutoff by spiking PdG into simulated urine. Each participant provided with package insert, 1 or 2 blind labeled sample and 1 or 2 devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
| PDG Concentration | -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 - |
Lay User Study Results:
| PDG conc | # neg | # pos | % correctly interpreted |
|---|---|---|---|
| 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 |
| Results demonstrate that lay women can correctly read Proov results over 99% of the time (121 of the 121 samples). |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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.
4
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 LIA
Test | Comments on
Substantial Equivalence | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Luminescence
immunoassay for the in
vitro diagnostic
quantitative measurement
of active free
progesterone (a female
hormone) in saliva.
Measurements obtained
by this device may be
used in the diagnosis and
treatment of disorders of
the ovaries and can be
used as an aid for
confirmation of ovulation. | The devices are both used
for the confirmation of
ovulation. | |
| Materials | Antibody and Antigen
Nitrocellulose Membrane
Colloidal Gold Conjugate Pad
Sample Pad | - Microtiter Plate
coated with rabbit
anti-mouse antibody
- Progesterone
Antiserum (mouse
anti-progesterone
antibody) - Standards A-G (0,
20, 25, 50, 100, 300,
and 1000 pg/mL);
progesterone in
buffer with BSA and
stabilizers - Controls Level I and
II | 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 | In vitro diagnostic device
consisting of 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 presence of
hormone metabolites in urine.
The test strip is intended for
use outside of the body, 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. Presence of PdG
confirms that ovulation has
occurred. | 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 based
on the competition assay
principle. An unknown
amount of antigen present
in the sample and a fixed
amount of enzyme labeled
antigen compete for the
binding sites of the
antibodies/antigens coated
onto the wells. Results of
samples can be
determined directly using
the standard curve. | The subject device is
similar to the predicate
device with use of the
competition principle and
use of antigen to compete
for the binding site of the
targeted antibody. |
| Analyte | Pregnanediol Glucuronide
(PdG) | Progesterone | The predicate measures
progesterone and the
subject device measures a
progesterone metabolite,
PdG. | |
| Method | Lateral flow
Immunoassay/competition
principle | ELISA
Immunoassay/competition
principle | Immunoassay/competition
principle, therefore
equivalent. | |
| Specimen | Urine | Saliva | Both are clinically valid
specimens for targeted
analyte. | |
| Intended
Population | For over-the-counter and
prescription uses | Prescription use | Proov has been
successfully validated
with lay-users. | |
| Reading | Visual, colloidal gold | Luminescence | Subject device is | |
| Indicator | | | qualitative and the
predicate is
quantitative.
Comparison of Proov
vs. ELISA method to
support equivalence. | |
| Performance
Testing | Precision/Reproducibility
Study
Traceability Control
Detection Limit
Analytical
Specificity/Interference/Cross-
Reactivity
Specific Gravity and pH
Hook Effect
Comparison Study
Lay User Study | Precision/Reproducibility
Linearity
Traceability Control
Detection Limit
Analytical Specificity
Comparison Studies | The testing conducted
was similar for both
the predicate and
subject devices with
the exception that the
predicate device
required linearity
testing, which is not
applicable to a lateral
flow assay. | |
5
6
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
| PDG
Concentration | -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.
7
| 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.
8
| 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 | % correctly
interpreted |
|----------|-------|-------|----------------------------|
| 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.