(101 days)
Immunoassay for in vitro diagnostic use in hospital, clinical laboratories and physician’ offices for the qualitative detection of Human Chorionic Gonadotropin (hCG) in serum or urine for the early detection of pregnancy.
Status hCG™ Serum/Urine is simple one step immunochromatographic test for the rapid, qualitative detection of hCG in serum or urine.
Here's a breakdown of the acceptance criteria and study details based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| 100% correlation with predicate device for urine samples. | 100% correlation with QuickVue® hCG Combo Test |
| 100% correlation with predicate device for serum samples. | 100% correlation with QuickVue® hCG Combo Test |
Note: The 510(k) summary directly states the outcome of the study as the acceptance criteria. For devices showing substantial equivalence, the primary "acceptance criterion" is often demonstrating performance that is equivalent to or better than a legally marketed predicate device. In this case, "100% correlation" to the predicate device is presented as the meeting of this implicit criterion.
Study Details
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 100 specimens (50 negative, 50 positive) for urine tests AND 100 specimens (50 negative, 50 positive) for serum tests.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the 510(k) summary. The ground truth seems to be established by the results of the predicate device, QuickVue® hCG Combo Test.
4. Adjudication Method for the Test Set:
- Not applicable/Not specified as the comparison is against a single predicate device's results, not an independent ground truth established by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case comparative effectiveness study was not done. The study compares the performance of the new device to a predicate device, not human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, this study represents a standalone performance evaluation of the Status hCG™ Serum/Urine device. It functions as an IVD (in vitro diagnostic) test, and its results are read directly, not through an algorithm requiring human-in-the-loop interaction in the context of this 510(k).
7. Type of Ground Truth Used:
- The ground truth for this study was established using the results from a legally marketed predicate device, the QuickVue® hCG Combo Test. The language "100% correlation when 100 specimens were compared" indicates the predicate device's results were used as the reference standard.
8. Sample Size for the Training Set:
- Not applicable/Not specified. This device is an immunochromatographic test, not an AI/machine learning algorithm that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of diagnostic device.
§ 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.