(125 days)
The Bayer Healthcare Clinitest hCG Pregnancy Test is for in vitro diagnostic use as a qualitative method in the rapid detection of human chorionic gonadotropin (hCG) in urine specimens. The test is utilized with the Clinitest Status analyzer and is intended for near patient (point of care) and centralized laboratory locations.
The Clinitest® hCG is a qualitative test for the rapid detection of human chorionic gonadotropin (hCG) in urine. The device is read by the Clinitek Status instrument.
This document describes a 510(k) premarket notification for the Clinitest® hCG Pregnancy Test. The information provided focuses on the device's substantial equivalence to predicate devices and general regulatory information, rather than a detailed study proving the device meets specific acceptance criteria with performance metrics.
Therefore, many of the requested sections (e.g., sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC study details, ground truth specifics for training) cannot be extracted from the provided text. The document is a regulatory submission summary, not a full study report.
However, I can extract the following based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" for performance metrics (like sensitivity, specificity, or accuracy) or report specific device performance values in a table. It only states that the device has "similar technological characteristics, device performance and intended use" to its predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical criteria in the provided text. The overarching "acceptance criterion" from a regulatory perspective is "substantial equivalence" to predicate devices. | The document states the device has "similar technological characteristics, device performance and intended use" as the predicate devices. It provides no specific numerical performance data (e.g., sensitivity, specificity, accuracy). |
2. Sample size used for the test set and the data provenance
Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the document.
5. 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
Not applicable. This device is a rapid diagnostic test read by an instrument (Clinitek Status analyzer), not an AI-assisted diagnostic imaging device requiring human reader interpretation in the context of MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device, when read by the Clinitek Status instrument, operates in a "standalone" manner for interpreting the test result (positive, borderline, or negative). However, the document does not provide a standalone performance study report with specific metrics. It simply describes the device's function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not provided in the document. For pregnancy tests, ground truth typically involves confirmation with a more definitive method (e.g., quantitative hCG measurement, clinical outcome).
8. The sample size for the training set
Not applicable/Not provided. This is a point-of-care rapid diagnostic test, not an AI/machine learning device that would typically have a "training set" in the computational sense. The "training" for such devices usually refers to manufacturing process development, reagent optimization, and internal verification/validation, not a dataset for algorithm training.
9. How the ground truth for the training set was established
Not applicable/Not provided (as per point 8).
§ 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.