(45 days)
CHOICE accu-test™ is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. This test is intended for overthe-counter use.
CHOICE accu-test™ detects the presence of hCG in urine by using a combination of polyclonal and monoclonal antibodies on the reagent pad and the test strip. The assay begins functioning with the addition of urine onto the absorbent wick. Through capillary action the urine is pulled along the membrane to the reagent pad where the hCG reacts with the conjugate. Positive results are determined by two colored lines in the window. The absence of hCG produces only one colored line in the window.
Here's a breakdown of the acceptance criteria and study information for the CHOICE accu-test™ One-Step Pregnancy Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Specificity | >99% acceptance | >99% |
| Sensitivity | >99% acceptance | >99% |
| Accuracy | >99% acceptance | >99% |
| Interfering Substances | >99% acceptance | >99% |
| Stability Studies | >99% acceptance | >99% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 132 test devices were compared.
- Data Provenance: Not explicitly stated whether retrospective or prospective. The country of origin of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in vitro diagnostic for a clear biological marker (hCG), and the ground truth would be established by the presence or absence of hCG, likely via a laboratory reference method. The text does not mention the use of human experts for ground truth establishment in this context.
4. Adjudication Method for the Test Set
Not applicable, as expert adjudication is not mentioned for establishing ground truth for this type of test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study described is a comparison study against a predicate device, not an evaluation of human readers with vs. without AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
Yes, a standalone performance study was done. The device itself is a standalone diagnostic test, and the reported performance metrics (Specificity, Sensitivity, Accuracy) reflect its inherent performance in detecting hCG.
7. Type of Ground Truth Used
The ground truth used for the comparison study would have been the results obtained from the "SAS™ Serum/Urine hCG Pregnancy Test Kits," which served as the reference method. This indicates a comparison to a predicate/reference diagnostic method rather than expert consensus, pathology, or outcomes data. For an hCG test, the ground truth is ultimately the actual presence or absence of the hCG hormone.
8. Sample Size for the Training Set
The document does not mention a "training set" as this is a traditional in vitro diagnostic device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical 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.