(124 days)
The OSOM hCG Combo test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum as an aid in the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.
The OSOM hCG Combo device is a solid phase, sandwich-format immunochromatographic assay for the qualitative detection of hCG. Urine or serum is added to the sample well of the test device using the fixed volume Pipette provided. The sample migrates through reaction pads where hCG, if present in the sample, binds to a monoclonal anti-hCG dye conjugate. The sample then migrates across a membrane towards the results window, where the labeled hCG complex is captured at a test line region containing immobilized rabbit anti-α hCG. Excess conjugate will flow past the test line region and be captured at a control line region containing an immobilized antibody directed against the anti-hCG dye conjugate (with or without hCG complexed to it). The appearance of two gray or black bands in the results window indicates the presence of hCG in the sample. If a detectable level of the hCG is not present, only the control band will appear in the results window.
Here's a breakdown of the acceptance criteria and the study details for the OSOM hCG Combo test, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Agreement with a currently marketed qualitative hCG assay. | Urine samples: >99% agreement for both positive and negative results. |
| Serum samples: >99% agreement for both positive and negative results. |
Study Details
1. Sample Sized used for the test set and the data provenance:
- Urine Test Set: 634 samples
- Serum Test Set: 691 samples
- Data Provenance: Not explicitly stated whether retrospective or prospective, nor the country of origin.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. The comparison was made against a "currently marketed qualitative hCG assay," implying the predicate device's results were accepted as the reference.
3. Adjudication method for the test set:
- Not applicable/Not explicitly stated. The comparison was a direct agreement with a predicate device. There is no mention of independent expert adjudication.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a rapid immunoassay for qualitative detection, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, this was a standalone performance study. The device itself performs the detection and provides a visual result (bands). The study assesses the device's accuracy in producing these results compared to a reference standard.
6. The type of ground truth used:
- The ground truth was established by comparison to the results obtained with a currently marketed qualitative hCG assay (presumably the predicate device, Quidel QuickVue®+ One-Step hCG Combo Test). This implies a comparative agreement study where the predicate device serves as the reference standard.
7. The sample size for the training set:
- Not applicable/Not explicitly stated. This device is a traditional immunoassay, not a machine learning or AI-based system that typically requires a discrete training set. The "development" and "validation" would rely on analytical studies and clinical performance rather than a separate "training set" in the AI sense.
8. How the ground truth for the training set was established:
- Not applicable (as per point 7).
§ 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.