(64 days)
FSH Menopausal Test is a rapid Step The One chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of the onset of menopause. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH. This device is intended for both professional and lay person use.
One Step FSH Menopausal Test is a rapid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH.
Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the "One Step FSH Menopausal Test":
A. Acceptance Criteria and Reported Device Performance
The acceptance criteria for diagnostic tests often involve measures like sensitivity, specificity, and accuracy, especially when comparing to a reference method or clinical endpoint. While the specific numerical acceptance criteria established by the manufacturer are not explicitly detailed in this FDA letter (which typically focuses on substantial equivalence), the provided data implies a performance standard for "positive agreement" and "negative agreement" in comparison to a predicate device or clinical reference.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Professional Use | |
| Positive Agreement | 90.3% |
| Negative Agreement | 92.2% |
| Overall Agreement | 91.5% |
| Lay Use | |
| Positive Agreement | 90.3% |
| Negative Agreement | 92.2% |
| Overall Agreement | 91.5% |
| Accuracy (Against Clinical Reference) | |
| Negative Reference | 92.2% |
| Positive Reference | 90.3% |
Note: The FDA 510(k) summary usually provides the specific acceptance criteria. This document indicates the device is "substantially equivalent," meaning its performance is comparable to a legally marketed predicate device, implicitly meeting accepted performance standards for its intended use.
B. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the specific sample size used for the test set in a clinical study to validate these performance metrics. The agreement percentages (Positive Agreement, Negative Agreement, Overall Agreement) are listed, but the accompanying sample sizes for "Professional Use" and "Lay Use" are not present in this excerpt.
- Data Provenance: Not specified in this document. It does not mention the country of origin of the data or whether the study was retrospective or prospective.
C. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not available in the provided document. For an FSH Menopausal Test, the "ground truth" for elevated FSH levels would likely be established by a laboratory assay (e.g., ELISA) for quantitative FSH levels, interpreted by a qualified medical professional (e.g., endocrinologist, gynecologist). The document doesn't detail the involvement of experts in establishing the ground truth or their qualifications.
D. Adjudication Method for the Test Set
This information is not available in the provided document. Adjudication methods (e.g., 2+1, 3+1) are typically used in imaging or subjective interpretation studies. For a diagnostic test like this, the ground truth is usually established by a reference method (e.g., quantitative laboratory FSH measurement), making multi-reader adjudication less relevant in the same way.
E. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which typically evaluates how AI assistance impacts human reader performance, is not applicable to a single-use, qualitative in-vitro diagnostic test like the One Step FSH Menopausal Test. This device is not an AI-assisted interpretation tool.
F. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, in essence. This device inherently operates as a "standalone" test. The "performance" figures provided (Positive Agreement, Negative Agreement, Overall Agreement) reflect the device's ability to accurately detect FSH in urine samples, without human intervention in the detection process itself. The "Lay Use" section specifically evaluates its performance when interpreted by non-professionals, which is a key aspect of its standalone functionality for over-the-counter use.
G. The Type of Ground Truth Used
The ground truth used for performance evaluation is indicated by "Clinical Reference" and "Negative Reference" / "Positive Reference." This strongly suggests that the device's results were compared against an established clinical reference method for FSH levels (likely a quantitative laboratory assay) to determine true positive and true negative cases.
H. The Sample Size for the Training Set
This information is not available in the provided document. For a traditional in-vitro diagnostic test, there isn't a "training set" in the machine learning sense. The device's components (antibodies, reagents) are developed and optimized through research and development, but the sample sizes involved in that development process are distinct from the clinical validation (test set) discussed above.
I. How the Ground Truth for the Training Set Was Established
Not applicable in the machine learning sense. The "ground truth" for the development of such a test would involve confirming the specificity and sensitivity of the antibodies and reagents against known concentrations of FSH, using established laboratory standards and methods. This is part of the product development and quality control process, rather than a "training set" in AI/ML terminology.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. The seal is black and white and has a simple, clean design.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 3 0 2005
Mr. Jason Peng Manger of Regulatory Affairs IND Diagnostic Inc. 1629 Fosters Way Delta, B.C. V3M 6S7 Canada
Re: K052662 Trade/Device Name: One Step FSH Menopausal Test Regulation Number: 21 CFR 862.1300 Regulation Name: Follicle-stimulating hormone test system Regulatory Class: Class I Product Code: CGJ Dated: September 22, 2005 Received: September 28, 2005
Dear Mr. Peng;
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. 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.
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 can be found in Title 21, Code 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 or any Federal 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 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. 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 Division 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/industry/support/index.html.
Sincerely yours,
Alberto G.
Alberto Gutierrez, Ph.D. 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):
Device Name:
Indications For Use:
K05 2662
One Step FSH Menopausal Test
FSH Menopausal Test is a rapid Step The One chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of the onset of menopause. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH. This device is intended for both professional and lay person use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Lucy Phillips
(Division Sign-Off)
Division of Clinical Laboratory Devices
Division of Clinical Laboratory Devices
510(k) Number K052662
§ 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.