(37 days)
The QuickVue® One-Step hCG-Urine is a one-step immunoassay intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. The QuickVue One-Step hCG-Urine is intended for use by health care professionals.
The test is a rapid immunoassay for the qualitative detection of hCG in urine. This test is to be used for the early detection of pregnancy. The test, a lateral-flow immunoassay, employs monoclonal and polyclonal antibodies. Shortly after addition of the urine sample, a blue procedural Control Line will appear. If hCG is present in the sample, a pink-to-purple Test Line will also appear. The result is read at three minutes. If no blue procedural Control Line develops, the result is considered invalid.
Here's a breakdown of the acceptance criteria and study information for the QuickVue® One-Step hCG-Urine device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Requirement | Reported Device Performance |
|---|---|---|
| Accuracy | > 99% accuracy when compared to other FDA-cleared devices for qualitative hCG detection. | An accuracy exceeding 99% was observed. |
| Precision | Excellent intra- and inter-assay precision. | The test was shown to have excellent intra- and inter-assay precision. |
| Lot-to-Lot Consistency | Reproducibly manufacturable. | Lot-to-lot consistency analyses showed the test to be reproducibly manufacturable. |
| Interference | No interference from common drugs, chemicals, and biologicals. | Common drugs, chemicals, and biologicals were shown not to interfere with the test's performance. |
| Usability (Physician's Office Laboratory) | Doctor's office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly. | Testing was performed at three geographically distinct sites in the United States. The results obtained at each site agreed 100% with the expected results. |
| Substantial Equivalence | Similar to other commercially distributed in vitro tests in terms of features and intended use. | The test was shown to be similar to other commercially distributed in vitro tests in terms of features and intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the primary accuracy study comparing the QuickVue® device to other FDA-cleared devices. It mentions "Using urine samples obtained from women presenting for pregnancy testing."
- Data Provenance:
- Accuracy Study: Urine samples from women presenting for pregnancy testing (implicitly prospective data collection, but not explicitly stated as such, suggesting real-world clinical samples).
- Physician's Office Laboratory Studies: Conducted at "three geographically distinct sites in the United States." This implies retrospective use of existing samples or prospective collection within those sites, but the exact collection method isn't detailed.
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 given text. For a qualitative hCG test, the "ground truth" would typically come from a reference method or a panel of experts confirming pregnancy status, but the details are absent.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
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
- No MRMC study was done. This device is an in-vitro diagnostic (IVD) rapid immunoassay for qualitative detection of hCG in urine, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of an MRMC study. The "readers" would be the healthcare professionals performing and interpreting the test based on the color change. The Physician's Office Laboratory studies assessed the reproducibility and accuracy of personnel.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done in the sense that the device itself, as an immunoassay, produces a result (color change) that is then interpreted. The "accuracy exceeding 99%" was reported for the device's performance against FDA-cleared predicate devices. The Physician's Office Laboratory studies evaluate human interpretation of the device's standalone output.
7. The Type of Ground Truth Used
- The ground truth for the accuracy study comparing the QuickVue® device was based on results from "other FDA-cleared devices for qualitative hCG detection." This implies a comparison to established, legally marketed diagnostic tests that themselves have a defined accuracy against the biological presence of hCG.
- For the Physician's Office Laboratory studies, the ground truth was referred to as "expected results." This likely refers to a pre-determined or confirmed pregnancy status of the urine samples used.
8. The Sample Size for the Training Set
This information is not provided in the given text. As the device is an immunoassay (not an AI/ML algorithm), the concept of a "training set" in the context of machine learning does not directly apply. The development would involve analytical verification and validation using various concentrations of hCG and negative controls.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable in the typical AI/ML sense. For immunoassay development, ground truth for validation samples (analogous to a "training set" in a very loose sense for analytical performance) would be established by preparing samples with known concentrations of hCG and negative controls, and potentially using a highly sensitive and specific reference method.
§ 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.