(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.
§ 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.