(44 days)
Not Found
No
The device description and performance studies indicate a qualitative, one-step immunoassay for detecting FSH in urine, which is a standard biochemical test method and does not involve AI/ML. There is no mention of AI, ML, or related concepts in the summary.
No
The device is an in vitro diagnostic (IVD) test used to detect FSH in urine as an aid in predicting menopause, not to treat, mitigate, or cure a disease or condition.
Yes
Explanation: The device is used as an aid in predicting menopause by detecting FSH levels, which is a diagnostic purpose.
No
The device description clearly states it is a "midstream test" and an "in vitro diagnostic use" device, which are physical components used to detect FSH in urine. This indicates it is a hardware-based test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative, one-step, midstream assay for the detection of Follicle Stimulating Hormone (FSH) in urine". This involves testing a biological sample (urine) outside of the body.
- Device Description: The description further clarifies that it's "intended for use outside the body (in vitro diagnostic use)".
- Mechanism: The device works by detecting a specific analyte (FSH) in a biological sample (urine) to provide information about a physiological state (predicting menopause). This is the core function of an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
CGJ
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. 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.
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
Intended User / Care Setting
lay consumer / home
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
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 later. Each volunteer conducted the testing at home according to the package insert 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 Performance Studies
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®.
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
Key Metrics
Accuracy
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
Sponsored by:
ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, CA 92121 FDA Establishment Registration: 2531491
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:
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.
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.
1
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
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo with two distinct parts. On the left, there is a circular emblem with text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA." To the right of the emblem, there is a stylized graphic of an eagle, depicted with bold, flowing lines that suggest movement and flight.
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).
3
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
4
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)
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