(21 days)
The Phamatech At Home Ovulation Test is a rapid qualitative test for the detection of luteinizing hormone (LH) in urine. The cut-off concentration for this test is as follows: LH at 30mlU/mL. This assay is intended for use in the home to assist in determining the ovulation cycle. The Phamatech At Home Ovulation Test is intended for over the counter use.
Immunoassay for the qualitative detection of LH in urine. The At HOME OVULATION TEST, like many commercially available ovulation test kits, qualitatively measures the presence of luteinizing hormone by visual color sandwich one step immunoassay technology. All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / LH / colored (labeled) antibody complexes.
The Phamatech At HOME OVULATION TEST (Model 9032) is a rapid, qualitative immunoassay for the detection of luteinizing hormone (LH) in urine at a cut-off concentration of 30mlU/mL. It is intended for home use to assist in determining the ovulation cycle.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with predicate device (Syntron Be Sure Test) | >99% correlation in clinical sample correlation study |
| Overall accuracy in professional hands | >98% overall accuracy in clinical studies at two independent laboratories |
| Overall accuracy in consumer hands | "Excellent overall accuracy" (specific percentage not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The exact sample sizes for the clinical sample correlation study, the clinical studies with professional users, and the consumer study are not explicitly stated in the provided document. The data provenance is described as "clinical specimens" and "clinical studies, performed at two independent laboratories," suggesting that the data is prospective and likely collected in a clinical setting. The country of origin of the data is not specified, but the manufacturer is based in San Diego, California, USA, implying the studies were likely conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions "professional users" in clinical studies, but their role in establishing ground truth versus simply performing the test is unclear.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance data focuses on the device's accuracy and correlation, not on comparing human reader performance with and without AI assistance. This device is a rapid diagnostic test, not an AI-driven image analysis tool.
6. Standalone Performance
Yes, standalone performance (algorithm only performance, without human-in-the-loop) was assessed. The "At HOME OVULATION TEST" is a standalone device that provides a visual result directly to the user, the manufacturer or a professional user would determine the performance data as reported above, but also included in this filing is consumer user performance. The device's performance metrics (correlation, overall accuracy) reflect its inherent ability to detect LH. The "consumer study" further assesses its standalone performance when interpreted by lay users.
7. Type of Ground Truth Used
The ground truth for the clinical sample correlation study was established by comparing the At HOME OVULATION TEST results to the Syntron Be Sure Test, a predicate device. For the clinical studies and consumer study, the ground truth would typically be established through established laboratory methods or medical assessment of the individual's LH levels, though the exact method is not detailed in the provided document. Given it's an ovulation test, the ground truth for LH levels would likely be based on quantitative immunoassay results or other accepted methods for measuring LH in urine.
8. Sample Size for the Training Set
The document does not provide information regarding a "training set" or its sample size. This device relies on "basic immunochemical sandwich assay principle," not on machine learning or AI models that require specific training sets.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML model, there is no information on how its ground truth was established.
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510(k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
At HOME OVULATION TEST (Model 9032) Identification:
Immunoassay for the qualitative detection of LH in urine. Description:
Phamatech Name of Manufacturer: 9530 Padgett Street Suite #101 San Diego, California 92126, USA
Intended Use: The At HOME OVULATION TEST is a rapid, qualitative immunoassay for the detection of luteinizing hormone (LH) in urine. The cut-off concentration for this test is as follows: LH at 30mlU/mL. This assay is intended for use in the home to assist in determining the ovulation cycle.
Technology: The At HOME OVULATION TEST, like many commercially available ovulation test kits, qualitatively measures the presence of luteinizing hormone by visual color sandwich one step immunoassay technology. Examples of such predicate devices include the Phamatech (San Diego, CA) OvuCard and the Quidel OvuQuick LH Test (San Diego, CA 92121). All of the above devices rely on the basic immunochemical sandwich assay principle of recognition and formation of specific antibody / LH / colored (labeled) antibody complexes.
Performance: The product performance characteristics of the At HOME OVULATION TEST were evaluated in a clinical sample correlation study and a blind labeled spiked study. The results of these studies demonstrate the Phamatech At HOME OVULATION TEST to be substantially equivalent to the reported performance characteristics of other commercially available tests for the qualitative detection of luteinizing hormone in urine. Correlation studies, using clinical specimens, produced a >99% correlation when compared to the Syntron Be Sure Test. Clinical studies, performed at two independent laboratories, were also performed. In them the Phamatech At HOME OVULATION TEST exhibited excellent overall accuracy (>98%) in the hands of professional users. A consumer study was also performed, in it the At HOME OVULATION TEST exhibited excellent overall accuracy. Consumer interpretation of the LH test showed accuracy to be
Conclusion: For the reasons mentioned above, it may be concluded that the Phamatech At HOME OVULATION TEST is substantially equivalent to a variety of detection tests currently in commercial distribution and is safe in the hands of the lay user.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 4 2002
Mr. Carl A. Mongiovi Vice President Pharmatech, Inc. 9530 Padgett Street - Suite #101 San Diego, CA 92126
Re: K021409
Trade/Device Name: At Home Ovulation Test (Model 9032) Regulation Number: 21 CFR 862.1485 Regulation Name: Luteinizing hormone test system Regulatory Class: Class I Product Code: CEP Dated: April 25, 2002 Received: May 3, 2002
Dear Mr. Mongiovi:
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 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: At Home Ovulation Test (Model 9032)
Indications for Use:
The Phamatech At Home Ovulation Test is a rapid qualitative test for the The I hamateen At Homo Oralation of the intended for over the counter use.
Please DO NOT WRITE BELOW THIS LINE
Concurrence of the CDRH Office of Device Evaluation (ODE)
Jean Cooper
(Employee Sign-Off)
Division of Clinical Laboratory Devices
Division Sign off Division of Clinical Laboratory Devices 510 (k) Number:
Over the Counter: OR Prescription Use:_ Per 21 CFR 801.109
§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(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.