(165 days)
The ACRO hCG Pregnancy Rapid Test is used by the consumer for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine. It is used to detect the pregnancy of HCG in urine as an indication of pregnancy.
The ACRO HCG Pregnancy Rapid Test is designed to be tested in midstream 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 consumer-use device for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine to detect pregnancy.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | Rapid qualitative detection of hCG to aid in the early detection of pregnancy. |
| Cutoff | 25 mIU/mL |
| Test Principle | Lateral flow Sandwich Immunochromatographic Assay |
| Positive Result | 2 colored lines |
| Negative Result | 1 colored line |
| Detection Reagent | Colloidal gold |
| Specificity | Negative at: |
| hLH: 500mIU/ml | |
| hFSH: 1000mIU/mL | |
| hTSH: 1000 µIU/mL | |
| Traceability | WHO 4th International Standard |
| Critical Raw Materials (source) and Preparation Formulas | Antibody and Antigen |
| Nitrocellulose Membrane | |
| Colloidal Gold Conjugate Pad | |
| Sample Pad | |
| Component Strip | Width and Length |
| Critical Production Process | Membrane spray/coating |
| Conjugate Pad | |
| Sample pad treatment | |
| Storage Temperature | 35 – 86°F (2 – 30 °C) |
| Read Time | 3 to 10 minutes |
| Device Format | Midstream without Absorbent Tip and Midstream with Absorbent Tip |
| Verification and Validation | Lay user performance, Precision, Time Flex, Storage, and Stability Studies were conducted and passed acceptance criteria. |
2. Sample Size for the Test Set and Data Provenance
The provided document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Lay user performance, Precision, Time Flex, Storage and Stability Studies were conducted and passed acceptance criteria."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document refers to "Lay user performance" studies, which implies testing by intended users rather than experts establishing a ground truth for diagnostic accuracy. For an OTC device like a pregnancy test, the "ground truth" for lay user performance typically involves whether the user can correctly interpret the test result based on provided instructions, not necessarily the diagnostic accuracy of the device against a clinical "gold standard."
4. Adjudication Method for the Test Set
This information is not provided in the document. Given the nature of a rapid pregnancy test designed for consumer use, and the absence of specific details on expert interpretation, it's unlikely a formal adjudication method by multiple experts was employed for user performance studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This question is not applicable to the ACRO HCG Pregnancy Rapid Test. This device is a standalone in-vitro diagnostic test, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The ACRO HCG Pregnancy Rapid Test is a standalone device in the sense that its result is determined by chemical reaction and visual interpretation by the user. There is no "algorithm only" component or AI involved. The "standalone" performance here refers to the device's inherent ability to detect hCG accurately without further human intervention beyond performing the test and reading the results. The document implies this through the "Precision, Storage and Stability Studies."
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the performance studies (Precision, Specificity, etc.), the ground truth would likely be established through:
- Known concentrations: For precision and specificity, controlled urine samples with known hCG levels (including negative controls and samples spiked with interfering substances like hLH, hFSH, hTSH) would be used.
- WHO 4th International Standard: The document explicitly mentions "WHO 4th International Standard" for traceability, indicating that the device's performance is aligned with a recognized international standard for hCG measurement.
For the "Lay user performance" studies, the "ground truth" would likely be based on comparison with the manufacturer's expected result for the tested samples, and the user's ability to correctly obtain and interpret that result according to the instructions.
8. The Sample Size for the Training Set
This information is not applicable as the ACRO HCG Pregnancy Rapid Test is a chemical assay, not a machine learning or AI-driven device that requires a training set in that context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as 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.