FSH Menopause Predictor Test is a qualitative, one-step, midstream assay for the detection of Follicle Stimulating Hormone (FSH) in urine to be used as an aid in predicting menopause. The FSH Menopause Predictor Test is intended for over-the-counter use by the lay consumer.

Device Description

The FSH Menopause Predictor Test is a midstream test used for the qualitative measurement of FSH and the detection of Follicle Stimulating Hormone in a woman's urine as an aid in predicting menopause. The FSH predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. FSH Menopause Predictor is an over-the-counter (OTC) device and may be sold under various private labels.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the ACON Laboratories Inc. FSH Menopause Predictor Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Accuracy (ACON FSH Menopause Predictor Test (trained Lab Tech) vs. InstaCheck®)	>99% (99% - 99% CI)	This appears to be the primary criterion for substantial equivalence to the predicate device when used by trained personnel. Due to rounding, the confidence interval is very narrow.
Accuracy (ACON FSH Menopause Predictor Test (consumer) vs. ACON FSH Menopause Predictor Test (trained Lab Tech))	94% (92.1% - 95.6% CI)	This criterion assesses the performance of the device when used by the intended lay consumer compared to a trained professional using the same device. This demonstrates user-friendliness and reliability in the intended OTC environment.
Accuracy (ACON FSH Menopause Predictor Test (Consumer) vs. InstaCheck®)	94% (92.1% - 95.6% CI)	This criterion directly compares the consumer-used device to the predicate device, reflecting overall consumer performance against the established standard.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 70 females.
Data Provenance: The study was a prospective clinical trial as participants conducted tests at home according to instructions, and urine samples were collected for testing by a study coordinator. The location of the study (e.g., country of origin) is not explicitly stated in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth in this study was established using a substantially equivalent product (InstaCheck®) and the ACON FSH Menopause Predictor Test used by a trained lab tech.
The text refers to a "trained Lab Tech," implying a professional with specific training in operating such devices. No further details on the qualifications (e.g., years of experience, specific certifications) are provided for this "trained Lab Tech."

4. Adjudication Method for the Test Set

The text describes a comparison study rather than an adjudication process for a single ground truth. The "adjudication" was effectively done by comparing the results of the ACON FSH Menopause Predictor Test (both consumer-used and lab tech-used) against the InstaCheck® device. The data obtained from both devices were recorded as "Negative or Positive" without mention of an adjudication panel resolving discrepancies between the devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a traditional MRMC comparative effectiveness study was not done in the context of comparing human readers with and without AI assistance. This device is a diagnostic test kit, not an AI-powered diagnostic imaging tool that would typically involve radiologists or other human readers interpreting complex images.
However, the study does compare performance between the "trained Lab Tech" and the "consumer" using the ACON device, which could be seen as a form of multi-user comparison, albeit without an AI component. There is no "effect size of how much human readers improve with AI vs without AI assistance" as AI assistance is not part of this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance was done in the sense that the ACON FSH Menopause Predictor Test (when operated by a trained lab tech) was evaluated for its accuracy against the InstaCheck® product. This represents the device's inherent performance under controlled conditions. The "consumer" arm of the study also represents a standalone performance of the device in the hands of its intended user.

7. The Type of Ground Truth Used

The ground truth used was comparative performance against a legally marketed predicate device (InstaCheck®) and the device itself when operated by a trained professional. While not explicitly "pathology" or "outcomes data" in the traditional sense, the InstaCheck® device serves as an established clinical reference for FSH levels in this context. The study also uses the ACON device operated by a trained professional as a reference for assessing consumer performance.

8. The Sample Size for the Training Set

The provided text does not specify a training set sample size. This is likely because the FSH Menopause Predictor Test is a chemical-based in vitro diagnostic, not a machine learning or AI-driven device that requires a separate training set for algorithm development. The performance data presented are from a clinical trial (test set) designed to validate the device's performance.

9. How the Ground Truth for the Training Set Was Established

As there's no mention of a training set in the context of AI or machine learning for this device, a separate ground truth establishment method for a training set is not applicable based on the provided information. The device's mechanism is based on antibody-antigen reactions, not on learned patterns from a large dataset.

Summary

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K041165

JUN 1 7 2004

510(k) Submission ACON Laboratories, Inc. FSH Menopause Predictor Test

Page 31 of 36

510(k) SUMMARY

Date of Summary: 23 April 2004

Product Name:

FSH Menopause Predictor Test

Sponsor's Name:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, CA 92121

Manufactured by:

ACON Biotech (Hangzhou) Co. Ltd. 398 Tianmushan Road Gudang Industrial Park Hangzhou, P.R. China 310023

Correspondent in the U.S .:

Fran White MDC Associates 163 Cabot Street Beverly, MA 01963

Substantially Equivalent Devices:

Product: InstaCheck® FSH Menopause Test Manufactured by: Applied Biotech, Inc. 510(k) Number: K023408

PRODUCT DESCRIPTION:

INTENDED USE:

The FSH Menopause Predictor Test is a qualitative, one-step, midstream assay for the detection of Follicle Stimulating Hormone (FSH) in urine to be used as an aid in predicting menopause. The FSH Menopause Predictor Test is intended for over-the-counter use by the lay consumer.

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510(k) Submission ACON Laboratories, Inc. FSH Menopause Predictor Test

SUMMARY OF TECHNOLOGY:

The FSH Menopause Predictor Test employs a unique combination of mouse monoclonal-dye conjugate and goat polyclonal-solid phase antibodies to selectively identify Follicle Stimulating Hormone (FSH) in urine. As the urine flows through the absorbent portion of the device, the antibody-dye conjugate binds to the FSH forming an antibody-antigen complex. This complex binds to the anti-FSH antibody in the reaction zone and produces a pink-rose color band (T Line) that shows up within 3 minutes. When the FSH concentration is equal to or greater than 25 mIU/mL, the color intensity of the test line is equal to or greater than that of the reference line. When the FSH concentration is lower than 25 mIU/mL, the color intensity of the test line is lighter than that of the reference line. In the absence of FSH, there is no Test line formation. Test should not be read after 8 minutes have passed since sample application. The formation of a pink-rose color band (Reference Line) in the reference line area indicates that adequate sample volume has been applied and proper wicking has occurred.

PERFORMANCE DATA:

A clinical trial was done to compare the performance of the FSH Menopause Predictor Test to a substantially equivalent product (InstaCheck") manufactured by ABI. Data clearly demonstrate that the performance of the FSH Menopause Predictor Test is substantially equivalent to the InstaCheck®.

InstaCheck® vs. FSH Menopause Predictor Test

70 females tested the FSH Menopause Predictor Test to determine their respective FSH levels during the first week of cycle (Days 2 through 7, with Day 1 as the first day of menstruation). The test was repeated one week later. If the participant was no longer having regular periods, they took the test at any time during the month and repeated with the second test one week Each volunteer conducted the testing at home according to the package insert later. instructions. The urine samples were provided to the study coordinator for testing. The study coordinator tested each sample using the FSH Menopause Predictor Test and the InstaCheck®. The data obtained was recorded as Negative or Positive.

Summary of Results

ACON FSH Menopause Predictor Test (trained Lab Tech) vs. InstaCheck® Accuracy >99% (99% - 99%)*

ACON FSH Menopause Predictor Test (consumer) vs. ACON FSH Menopause Predictor Test (trained Lab Tech)

Accuracy = 94% (92.1% - 95.6%)*

ACON FSH Menopause Predictor Test (Consumer) vs. InstaCheck® Accuracy = 94% (92.1% - 95.6%)*
*Denotes 95% Confidence Interval

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUN 1 7 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Acon Laboratories, Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915

K041165 Re:

Trade/Device Name: FSH Menopause Predictor Test Regulation Number: 21 CFR 862.1300 Regulation Name: Follicle- Stimulating hormone test system Regulatory Class: Class I Product Code: CGJ Dated: June 8 2004 Received: June 9, 2004

Dear Ms. White:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o no re revea your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass sualed in the 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). and Cosmetic Free (110) that the device, subject to the general controls provisions of the Act. The r ou may, dierely mans of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device n may be subject to Jude of Federal Regulations (CFR), Parts 800 to 895. 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 that I Driman statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and in your of substantial equivalence of your device of your device to a legally premaired predicated device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desire openite meetion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may outum of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K041165

Device Name: __FSH Menopause Predictor Test

Indications for Use:

FSH Menopause Predictor Test is a qualitative, one-step, midstream assay for the r STI Michopause i redretor rest is a quant (FSH) in urine to be used as an aid in predicting decection of Formation Fredictor Test is intended for over-the-counter use by the lay consumer.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) _

(Posted November 13, 2003)

Page 1 of l

Regulation Number and Section

§ 862.1300 Follicle-stimulating hormone test system.

(a)
Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.(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.

JUN 1 7 2004

510(k) Submission ACON Laboratories, Inc. FSH Menopause Predictor Test

510(k) SUMMARY

Product Name:

Sponsor's Name:

Sponsored by:

Manufactured by:

Correspondent in the U.S .:

Substantially Equivalent Devices:

PRODUCT DESCRIPTION:

INTENDED USE:

510(k) Submission ACON Laboratories, Inc. FSH Menopause Predictor Test

SUMMARY OF TECHNOLOGY:

PERFORMANCE DATA:

Summary of Results

Page 2

Indications for Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

§ 862.1300 Follicle-stimulating hormone test system.