(77 days)
The Bayer Diagnostics Clinitest® hCG Pregnancy Test is an in vitro qualitative test for the rapid detection of human chorionic gonadotropin (hCG) at a cut-off concentration of 25 mlU/ml in urine. This test kit is used to obtain a visual result and is intended for professional and laboratory use.
Human Chorionic Gonadotropin (hCG) test system for the use in early detection of pregnancy.
Here's a breakdown of the acceptance criteria and study details for the Bayer Diagnostics Clinitest® hCG Pregnancy Test, based on the provided text:
Acceptance Criteria and Device Performance
The core acceptance criterion for this device appears to be its ability to accurately detect hCG at a specific concentration and differentiate between various hCG levels, particularly around the 25 mIU/mL cutoff.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity: Detect hCG at 25 mIU/mL | The device detects urinary hCG at 25 mIU/mL. |
| Accuracy (Agreement with Commercial Assay): 100% agreement with a commercial hCG immunoassay at tested concentrations (0, 25, 100 mIU/mL) | 100% agreement with the commercial hCG assay (ADALTIS Italia immunoradiometric assay) was observed for samples at 0, 25, and 100 mIU/mL. |
Study Details
2. Sample Size and Data Provenance
- Test Set (Sensitivity Study):
- Sample Size: 280 samples (20 samples per hCG concentration level across 7 levels x 2 product lots). Each sample was blind-labeled and tested.
- Data Provenance: The samples were prepared in-house by spiking negative urine (from 4 donors) with hCG standard. This suggests laboratory-controlled, prospective data generation rather than retrospective patient data.
- Test Set (Accuracy Study):
- Sample Size: 200 visual test results (68 samples at 0 mIU/mL, 66 at 25 mIU/mL, 66 at 100 mIU/mL).
- Data Provenance: The samples were prepared by pooling four urine specimens and spiking them with hCG, then tested at two external sites. This is also laboratory-controlled, prospective data.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Sensitivity Study: "Samples were randomly distributed among four visual readers for each product lot."
- Number of Experts: 4
- Qualifications: Not specified. It's likely they were trained laboratory personnel or similar, given the context of a professional-use device, but no specific professional titles (e.g., medical technologists, clinical laboratory scientists) or years of experience are listed.
- Accuracy Study: For the Clinitest® hCG results, it states "visual test results," implying human readers.
- Number of Experts: Not explicitly stated how many individual readers performed the tests at the external sites, only that there were "two external sites."
- Qualifications: Not specified.
4. Adjudication Method for the Test Set
- Sensitivity Study: The text mentions "four visual readers for each product lot" and then reports aggregate "Number of Positives" and "Number of Negatives." It does not explicitly describe an adjudication method (e.g., 2+1, 3+1). It's possible that each reader's result contributed to the count, or a consensus was reached, but the specific process isn't detailed.
- Accuracy Study: The results are reported as "Clinitest® hCG Visual Results" and "100% agreement of sample results with the commercial hCG assay." No specific reader adjudication process is detailed beyond the visual reading at two external sites.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, this was not an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device itself is a qualitative invitro diagnostic test for visual reading, not an AI-powered diagnostic tool. The "readers" mentioned are simply individuals interpreting the visual test results.
6. Standalone Performance Study
- Yes, a standalone performance study was done. The entire performance section describes the algorithm's (the test's) ability to detect hCG in urine samples independent of a human interpretation for comparison or assistance. The "visual readers" are the mechanism by which the device (algorithm) provides a result, not an interface for an AI. The device is intended to provide a visual result, and its performance is the standalone performance.
7. Type of Ground Truth Used
- Sensitivity Study: The ground truth was established by spiking negative urine with known concentrations of hCG standard. This is a highly controlled, synthetic ground truth. The hCG standard itself is calibrated against WHO 3rd International Reference Preparation (IRP).
- Accuracy Study: The ground truth for this study was established using a commercial hCG immunoassay (an immunoradiometric assay made by ADALTIS Italia). This is an external reference standard.
8. Sample Size for the Training Set
- The document does not describe a training set in the context of machine learning or AI. This is a traditional immunoassay device, not an AI algorithm. Therefore, the concept of a "training set" for an AI model is not applicable here.
9. How the Ground Truth for the Training Set Was Established
- As there is no mention of an AI algorithm or a training set, this question is not applicable to the provided information.
§ 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.