(54 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 QuickVue One-Step hCG-Combo is intended for use by health care professionals.
The test is a rapid immunoassay for the qualitative detection of hCG in serum or urine. This test is to be used for the early detection of pregnancy. 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-purple 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:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative "acceptance criteria" for accuracy, precision, or other measures as a predetermined threshold that must be met. Instead, it describes performance characteristics and comparisons to establish substantial equivalence.
Based on the information provided, here's a table summarizing the performance aspects:
| Performance Characteristic | Reported Device Performance |
|---|---|
| Accuracy (compared to predicate) | Exceeding 99% accuracy when compared to the Hybritech® ICON® II HCG ImmunoConcentration™ Assay for qualitative hCG detection. |
| Intra-Assay Precision | "Excellent" intra-assay precision. |
| Inter-Assay Precision | "Excellent" inter-assay precision. |
| Lot-to-Lot Consistency | "Reproducibly manufacturable." |
| Interference | Common drugs, chemicals, and biologicals were shown "not to interfere with the test's performance." |
| Usability (Physician's Office Lab) | Doctor's office personnel with diverse backgrounds could perform the test accurately and reproducibly. Results agreed 100% with expected results at three distinct U.S. sites. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Undisclosed. The document states "samples obtained from women presenting for pregnancy testing" were used for the direct comparison study.
- Data Provenance:
- Direct Comparison Study: Samples were "obtained from women presenting for pregnancy testing." The specific country of origin is not stated, but given FDA submission, it's highly probable the study was conducted in the U.S.
- Physician's Office Laboratory Studies: Conducted at "three geographically distinct sites in the United States."
- Retrospective or Prospective: Not explicitly stated, but the phrasing "samples obtained from women presenting for pregnancy testing" suggests these were likely prospective or collected contemporaneously with the study. The Physician's Office Lab studies appear to be prospective.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method (Test Set)
- Not explicitly described. The comparison was made "to the Hybritech ICON II HCG ImmunoConcentration Assay," which served as the reference standard. This implies independent determination by the predicate device as the ground truth, rather than human expert adjudication of agreement between the two tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The studies focused on the performance of the device itself, either in comparison to a predicate device or by laboratory personnel, rather than measuring the improvement of human readers (clinicians) with or without AI assistance. This device is an in-vitro diagnostic, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance assessment was conducted. The "accuracy exceeding 99%" reported for the comparison against the Hybritech ICON II HCG ImmunoConcentration Assay represents the standalone performance of the QuickVue One-Step hCG-Combo device. The Physician's Office Laboratory studies also demonstrated the device's standalone performance when used by varied personnel.
7. Type of Ground Truth Used
- For Accuracy Study: The ground truth was established by a predicate device, specifically the "Hybritech® ICON® II HCG ImmunoConcentration™ Assay for qualitative hCG detection." This assay itself would have its own established ground truth (likely clinical diagnosis or another gold standard for hCG detection).
- For Usability (Physician's Office Lab) Study: The ground truth was "expected results," which would be based on known positive and negative hCG samples or clinical diagnoses.
8. Sample Size for the Training Set
- Not applicable / Not disclosed. This device is a rapid immunoassay, a chemical and biological test system, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "development" and "optimization" phase of such a device would involve extensive testing and validation, but not typically a "training set" as understood in AI/ML contexts.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As mentioned above, there isn't a "training set" in the AI/ML sense for this type of immunoassay. The development and validation would involve biochemical principles and rigorous quality control rather than machine learning training.
§ 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.