(66 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 test is intended for use by health care professionals.
The test is a rapid immunoassay for the qualitative detection of hCG in urine. Urine is added to the Sample Well on the Test Cassette. Shortly after addition of the sample, a blue procedural Control Line will appear in the Result Window. If hCG is present in the sample, a pink-to-red Test Line will also appear. If hCG is not present, only the blue procedural Control Line will appear.
Here's a breakdown of the acceptance criteria and study information for the Quidel QuickVue® One-Step hCG-Urine device, based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly list numerical acceptance criteria in a table format, but it describes the types of studies performed and the qualitative outcomes. The primary implicit acceptance criterion is "substantial equivalence" to legally marketed predicate devices, supported by demonstrating similar performance characteristics.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Similar features and intended use | Demonstrated similarity to other commercially distributed in vitro tests. |
| Intra- and inter-assay precision | Shown to have "excellent" intra- and inter-assay precision. |
| Lot-to-lot consistency | Analyses showed the test to be "reproducibly manufacturable." |
| Interference testing | Common drugs, chemicals, and biologicals were shown "not to interfere" with the test's performance. |
| Accuracy (compared to predicate) | An accuracy "exceeding 99%" was observed in a multi-center field clinical trial comparing it to a commercially available qualitative hCG test. |
| Usability by healthcare professionals | Physicians' Office studies demonstrated that personnel with diverse educational backgrounds could perform the test "accurately and reproducibly." |
Study Details
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of individual samples. The text mentions "Using samples obtained from women presenting for pregnancy testing" for the accuracy study.
- Data Provenance:
- Country of origin of the data: Not explicitly stated, but the manufacturer is based in the U.S. (San Diego, CA, U.S.A.), indicating the studies likely took place in the U.S.
- Retrospective or Prospective: Not explicitly stated, but the "samples obtained from women presenting for pregnancy testing" for the accuracy study suggests a prospective collection from a clinical setting. The Physicians' Office studies would also be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. However, for the accuracy study, the comparator was a "commercially available qualitative hCG test." The " Physicians' Office studies" involved "physician office personnel with diverse educational backgrounds and work experience," implying general healthcare workers capable of performing point-of-care tests.
4. Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. For the accuracy study, "a direct comparison of the test to a commercially available qualitative hCG test was conducted," implying the commercial test served as the reference or ground truth, rather than an explicit adjudication process for disagreements between human readers.
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:
- MRMC Study: No, this device is a rapid in vitro diagnostic immunoassay, not an AI-assisted diagnostic device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not applicable.
- Effect Size: N/A (not an AI-assisted device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in a sense. The QuickVue device itself is a standalone test that produces a result (presence or absence of a line) without continuous human interaction during the reaction phase, after the user adds the sample. The "accuracy exceeding 99%" was based on the device's output compared to a reference test. The "Physicians' Office studies" looked at how human users perform the standalone test accurately and reproducibly.
7. The type of ground truth used:
- Type of Ground Truth: The primary ground truth for the accuracy study was the result from a "commercially available qualitative hCG test." This is a form of reference standard comparison against an accepted predicate device.
- For the precision and consistency studies, the ground truth would be expected values, which implies a controlled laboratory setting (e.g., gravimetric or volumetric standards, or established reference materials).
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set in that sense. The "training" in the context of this immunoassay would be the internal development and optimization of the assay components and parameters.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as it's not an AI device. The development process would involve extensive experimentation and quality control against known positive and negative hCG samples with established concentrations to optimize sensitivity, specificity, and other analytical performance characteristics.
§ 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.