FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The OSOM™ hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO USE ONLY.

Device Description

Wyntek's OSOM hCG- Urine Test uses color immunochromatographic stick technology with antibodies coated on the membrane. If hCG is present in urine, a blue test line will appear to indicate a positive result.

AI/ML Overview

Here's an analysis of the OSOM hCG-Urine Test's acceptance criteria and the study that proves its performance, based on the provided documents:

Acceptance Criteria and Device Performance for OSOM™ hCG-Urine Test

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Substantial Equivalence	Device must be substantially equivalent to a predicate device (Abbott Test Pack hCG Urine test) in technology and intended use.	The Wyntek™ OSOM® hCG-Urine Test is considered substantially equivalent to the Abbott Test Pack hCG Urine test. Both utilize membrane, monoclonal and polyclonal antibodies to identify hCG in urine and interpret results through color lines.
Analytical Sensitivity	Device should accurately detect hCG at clinically relevant levels for early pregnancy detection. (Though not explicitly stated as a numerical target, high sensitivity is implied for "early detection of pregnancy".)	In a limited sample size comparison with the Abbott TestPack Plus hCG Urine Test, the OSOM hCG-Urine Test demonstrated 100% sensitivity.
In the multi-site physician office evaluation, the device showed 100% agreement with expected results for negative, low positive, and moderate positive samples, indicating high sensitivity at different hCG concentrations.
Analytical Specificity	Device should accurately identify the absence of hCG and avoid false positives.	In a limited sample size comparison with the Abbott TestPack Plus hCG Urine Test, the OSOM hCG-Urine Test demonstrated 100% specificity.
In the multi-site physician office evaluation, the device showed 100% agreement with expected results for negative, low positive, and moderate positive samples, indicating high specificity.
Precision	Consistent and reproducible results.	An evaluation conducted at three physician offices, where a randomly coded panel of negative, low positive, and moderate positive samples were tested for three days, resulted in 100% agreement with the expected results. This suggests excellent precision and reproducibility across different users and days.

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

Comparison Study: "limited sample size" - The exact number of samples is not specified.
Physician Office Evaluation: A "randomly coded panel consisting of negative, low positive and moderate positive samples" was used. The total number of samples in this panel is not specified, nor is how many times they were tested over the three days.
Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given the context of a 510(k) submission for a diagnostic device prior to marketing, it is highly likely that these were prospective studies conducted specifically for regulatory submission, probably in the United States (where the company is based and the FDA operates).

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

The document does not specify the number of experts used to establish the ground truth.
The qualifications of those experts are also not mentioned. The physician office evaluation implies healthcare professionals (physicians or their staff) were involved in generating the results, but their role in establishing the "expected results" (ground truth) for the coded panel 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 physician office evaluation, it states "The results obtained had 100% agreement with the expected results," implying a direct comparison against a pre-established ground truth without a complex adjudication process between multiple readers of the new device.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This device is a rapid diagnostic test, not an imaging or complex interpretation system where MRMC studies are typically employed to assess human reader performance with and without AI assistance. The precision study involved multiple sites (physician offices) but not multiple readers for comparative effectiveness.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described primarily assess the standalone performance of the device itself (the OSOM hCG-Urine Test). Although human interpretation of the color lines is inherent to the use of such a test, the "100% agreement with expected results" suggests the test's intrinsic ability to correctly indicate positive or negative. The "algorithm" here is the immunochromatographic stick technology, and its performance is reported. There isn't an "AI" component mentioned that would typically distinguish between an algorithm-only and human-in-the-loop performance in the modern sense.

7. The Type of Ground Truth Used

For the comparison study with the Abbott TestPack Plus hCG Urine Test, the predicate device's results likely served as a form of ground truth or reference standard.
For the physician office evaluation, the ground truth was established as "expected results" for the randomly coded panel of negative, low positive, and moderate positive samples. This implies that the hCG concentration in these samples was independently confirmed (likely through a highly accurate laboratory method, though not specified) to determine their true positive/negative/concentration status. This would typically be a form of analytical reference standard based on known sample characteristics.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This device is a chemical immunoassay, not an AI or algorithm that requires a separate training phase with labeled data. All mentioned samples are for performance evaluation (test/validation).

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

As there is no "training set" in the AI/machine learning sense for this device, this question is not applicable. The device's underlying chemistry and design are based on established biological principles, not trained on data.

Summary

Regulation Number and Section

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.