(23 days)
The RapidVue hCG test is an immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine for the early detection of pregnancy. The test is intended for use by health care professionals.
The RapidVue hCG test uses a monoclonal antibody specific to the beta subunit of hCG in a single-step technology to accurately detect hCG. The Dipstick is dipped in urine. If hCG is present in the specimen at a level of 25 mlU/mL or greater, a pink-to-red Test (T) Line will appear along with a blue procedural Control (C) Line in the test result area. If hCG is present at lower levels, or not present in the specimen, only a blue procedural Control Line will appear in the test result area.
The provided text describes the RapidVue hCG test, an immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine for early pregnancy detection. The submission aims to demonstrate substantial equivalence to the predicate device, QuickVue One-Step hCG Urine Test (K020799).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a pass/fail threshold. Instead, it describes performance characteristics that the RapidVue hCG test aimed to demonstrate as being "consistent with" or "substantially equivalent" to the predicate device. For the purpose of this analysis, we will infer the predicate device's performance as the de facto "acceptance criteria" where specified.
| Performance Characteristic | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (RapidVue hCG) |
|---|---|---|
| Sensitivity | 25 mIU/mL | 25 mIU/mL (verified as consistent with predicate) |
| Prozone Effect | No prozone effect observed | No prozone effect observed (verified as consistent with predicate) |
| Urinary pH Affect | Not affected by variations in urinary pH | Not affected by variations in urinary pH (verified) |
| Procedural Robustness | Consistent with predicate's robustness | Demonstrated robustness |
| Clinical Accuracy | Accuracy consistent with QuickVue One-Step hCG Urine test | Accuracy consistent with QuickVue One-Step hCG Urine test |
| Reproducibility by POL personnel | Performance consistent with predicate when used by POL personnel | Performance evaluated by physician office personnel |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "procured clinical urine samples" for the clinical sample testing but does not specify the sample size for this test set nor the country of origin of the data. It indicates these samples were used to verify accuracy against the predicate. The type of study (retrospective or prospective) for the clinical samples is also not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used, or their qualifications, to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not provide information on any adjudication method used for the test set. Given the nature of a rapid diagnostic test for a clear biomarker, adjudication by multiple readers might not be typically required unless there were ambiguous results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The "Physician Office Laboratory (POL) Reproducibility Study" involved physician office personnel, which implies multiple readers, but it focuses on reproducibility of the RapidVue hCG test itself, not a comparative effectiveness study with and without AI assistance (as this is a non-AI device). Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable and not reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is a rapid diagnostic immunoassay device, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device's performance is inherently "standalone" in that it produces a result based on the chemical reaction, and then a human reads that result. The studies describe the device's inherent performance characteristics.
7. The Type of Ground Truth Used
The document implies the ground truth for the clinical sample testing would be the actual presence or absence of hCG in the urine samples, likely determined by a definitive laboratory method or clinical diagnosis of pregnancy. However, it does not explicitly state the specific method used to establish this definitive ground truth (e.g., expert consensus, pathology, outcome data, or a reference laboratory test). Given it's a quantitative measurement (hCG), a highly sensitive and specific lab assay is the most probable ground truth.
8. The Sample Size for the Training Set
This is a rapid diagnostic immunoassay, not a machine learning model that requires a "training set." Therefore, the concept of a "sample size for the training set" is not applicable. The device's performance is based on its chemical and biological design, not learned from data.
9. How the Ground Truth for the Training Set Was Established
As this is not a machine learning device, the concept of a "training set" and establishing "ground truth for the training set" is not applicable.
§ 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.