(56 days)
The ACRO hCG Pregnancy Rapid Test is for use by the over the counters for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine. It is to be used in either dip mode or midstream mode for the early detection of pregnancy.
The ACRO HCG Pregnancy Rapid Test is designed to be tested in midstream mode and dip mode.
The ACRO HCG Pregnancy Rapid Test consists of a single test strip encased in plastic device housing, with or without an additional absorbent tip. The result is generated by immersing the tip in the urine stream for a sufficient amount of time to absorb an adequate sample volume.
It is a rapid, one-step chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG.
The ACRO HCG Pregnancy Rapid Test is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine. It is intended for over-the-counter use for early detection of pregnancy in both dip mode and midstream mode.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not explicitly list formal "acceptance criteria" with numerical targets for clinical performance that would allow for a direct comparison table. However, it does state that "Lay user performance, Precision, Time Flex, Storage and Stability Studies were conducted and passed acceptance criteria". The provided comparison to the predicate device focuses more on technical specifications and design similarities.
The key performance characteristics implicitly demonstrated by the comparison to the predicate and the "passed acceptance criteria" for various studies are:
| Performance Characteristic | Reported Device Performance |
|---|---|
| Cutoff | 25 mIU/ml (Same as predicate) |
| Test Principle | Lateral flow Sandwich Immunochromatographic Assay (Same as predicate) |
| Positive Result | 2 colored lines (Same as predicate) |
| Negative Result | 1 colored line (Same as predicate) |
| Detection Reagent | Colloidal gold (Same as predicate) |
| Specificity | Negative at: hLH: 500mIU/ml, hFSH: 1000mIU/mL, hTSH: 1000 µIU/mL (Same as predicate) |
| Traceability | WHO 4th International Standard (Same as predicate) |
| Read Time | 3 to 10 minutes (Same as predicate) |
| Lay User Performance | Passed acceptance criteria |
| Precision | Passed acceptance criteria |
| Time Flex | Passed acceptance criteria |
| Storage & Stability | Passed acceptance criteria |
| Dip Mode Procedure | Successfully added (Difference from predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not specify the exact sample sizes for the "Lay user performance, Precision, Time Flex, Storage and Stability Studies."
The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.
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 supplied text. For a qualitative diagnostic test like this, ground truth would typically be established by a reference laboratory method (e.g., quantitative hCG measurement), not by a panel of experts.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a standalone diagnostic test, not an AI-assisted interpretation tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the studies conducted (Lay user performance, Precision, Time Flex, Storage and Stability Studies) evaluate the performance of the device itself (standalone performance) as designed to be used by over-the-counter consumers. It is a rapid diagnostic test where the user visually interprets the results.
7. The Type of Ground Truth Used
While not explicitly stated for all studies, for a device detecting hCG, the ground truth would typically be established by:
- Quantitative hCG measurement: Using a laboratory-based quantitative assay to determine the actual concentration of hCG in urine samples, which then serves as the reference standard for evaluating the rapid test's sensitivity and specificity at its stated cutoff (25 mIU/ml).
- Clinical correlation/outcomes data: Confirmation of pregnancy via other clinical means for relevant samples.
8. The Sample Size for the Training Set
The concept of a "training set" is typically applicable to machine learning or AI models. This device is a lateral flow immunoassay, not an AI algorithm. Therefore, there is no "training set" in that context. The "development" or "optimization" of such a test involves various analytical studies, but not a dataset used to train an algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI sense, this question is not applicable to this device. For the analytical studies and verification/validation, ground truth (e.g., known positive/negative hCG samples derived from quantitative methods) would have been used.
§ 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.