(66 days)
The QuickVue One-Step hCG-Combo is a one-step immunoassay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in serum or 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 serum or urine. Serum or 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 QuickVue® One-Step hCG-Combo device, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Similar to other commercially distributed in vitro tests in terms of features and intended use. | Yes |
| Excellent intra- and inter-assay precision | Yes |
| Reproducibly manufacturable (Lot-to-lot consistency) | Yes |
| Common drugs, chemicals, and biologicals do not interfere with performance. | Yes |
| Accuracy exceeding 99% compared to a commercially available qualitative hCG test. | >99% accuracy |
| Physician office personnel with diverse educational backgrounds and work experience (intended users) can perform the test accurately and reproducibly. | Yes |
Study Information
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "samples obtained from women presenting for pregnancy testing."
- Data Provenance: Not explicitly stated, but given the manufacturer is a U.S. company (Quidel Corporation, San Diego, CA), it is likely the data originated from the U.S. The studies were likely prospective as they involved "women presenting for pregnancy testing" and "Physicians' Office studies" to assess performance in real-world settings.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The study compared the device to a "commercially available qualitative hCG test." It's reasonable to infer that the ground truth was established by the results of this comparative method, which would themselves be interpreted by trained laboratory personnel or healthcare professionals. The document does not provide details on the qualifications of such individuals for establishing ground truth but references that the device is "intended for use by health care professionals."
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Adjudication method for the test set:
- Not described. The comparison was direct, suggesting the results of the QuickVue device were compared against the established results of the predicate device.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- Yes, indirectly. The "Physicians' Office studies" can be considered a form of MRMC study. These studies demonstrated that "physician office personnel with diverse educational backgrounds and work experience could perform the test accurately and reproducibly."
- Effect size of human readers with AI vs. without AI assistance: Not applicable. This device is a rapid immunoassay kit, not an AI-powered diagnostic tool. The "human readers" (physician office personnel) are performing the test and interpreting the visual result, not being assisted by AI. The study simply confirms they can do this accurately.
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If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
- Yes. The primary performance characteristic of "accuracy exceeding 99%" was observed in a "direct comparison of the test to a commercially available qualitative hCG test." This refers to the standalone analytical performance of the device itself.
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The type of ground truth used:
- Comparative Reference Standard: The ground truth was established by comparing the device's results to a "commercially available qualitative hCG test." This is a form of reference standard comparison, where the predicate device's results are considered the "truth." While not explicitly stated, it's highly probable that these commercial tests are themselves correlated with patient outcomes (pregnancy status confirmed by other clinical means, e.g., ultrasound, continued monitoring).
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The sample size for the training set:
- Not applicable. This device is a rapid immunoassay, not a machine learning or AI algorithm requiring a specific "training set." The development of the device would involve R&D and optimization, but not in the sense of a machine learning training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an immunoassay. The development process would involve internal validation and quality control measures to ensure the assay performs as intended.
§ 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.