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510(k) Data Aggregation
(100 days)
SOFIA(R) HCG FIA
The Sofia hCG FIA is an immunofluorescence-based lateral flow assay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine specimens and is designed to aid early detection of pregnancy. The test is intended for prescription use only, including use at point-of-care sites.
The test kit consists of individually packaged test Cassettes-each containing monoclonal murine antibodies for the capture and detection of hCG; disposable specimen transfer pipettes; and a package insert. The test is a qualitative immunofluorescence-based assay used to detect concentrations of 20 mIU/mL hCG or more in urine.
The Sofia hCG FIA is an immunofluorescence-based lateral flow assay intended for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine specimens to aid early detection of pregnancy. The device is for prescription use only, including at point-of-care sites.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria for each performance metric as distinct pass/fail thresholds. However, the performance data presented can be interpreted as demonstrating the device meets the implied requirements for accuracy and reliability for its intended use.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Analytical Sensitivity: Detect hCG at 20 mIU/mL or lower. | Detection Limit: The positive/negative threshold at which 100% of the samples tested positive was confirmed at 20 mIU/mL hCG. |
| Reproducibility: Consistent results across sites and operators. | Reproducibility: Tested at 3 laboratories by 3 operators each, using contrived samples (5-25 mIU/mL hCG). Results at each site agreed 100% with expected results. No significant differences observed within run, between runs, or between sites. |
| Absence of High-Dose Hook Effect: Correctly identify high hCG concentrations. | High Dose Hook Effect: Positive results observed up to 500,000 mIU/mL hCG. No hook effect observed for urine samples with hCG concentrations up to 500,000 mIU/mL. |
| Analytical Specificity: No interference or cross-reactivity from common substances. | Analytical Specificity: No cross-reactivity or interference observed for extensive lists of chemical substances (e.g., Acetaminophen, Aspirin, Caffeine, Ethanol), urine analytes (e.g., Albumin, Glucose, Hemoglobin), hormones (e.g., hLH, hFSH, hTSH, Estriol), and microorganisms (e.g., Escherichia coli, Candida albicans) at specified concentrations. pH (5-9) and Specific Gravity (1.005-1.037) also showed no interference. |
| Clinical Performance: High agreement with a commercially available qualitative test. | Clinical Performance (compared to a commercially available qualitative test): |
- Positive Agreement: >99% (176/177) (95% Cl=97-100%)
- Negative Agreement: >99% (795/797) (95% Cl=99-100%)
- Overall Agreement: >99% (971/974) (95% Cl=99-100%) |
2. Sample Size and Data Provenance for the Test Set:
- Sample Size for Clinical Performance (Test Set): 974 fresh urine specimens.
- Data Provenance: The clinical study was multi-center, conducted by health care personnel at five (5) distinct sites in various geographical regions within the United States. The data is prospective, collected from patients presenting for pregnancy testing.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical test set. The clinical performance study compares the Sofia hCG FIA to "a commercially available qualitative test," implying that the result from this comparator test served as the reference or ground truth.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the clinical test set. The comparison is directly between the Sofia hCG FIA and a single "commercially available qualitative test."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not explicitly performed or described in the provided text. The clinical study compares the device's performance to another commercial test, not to human readers with or without AI assistance. The Sofia hCG FIA is a rapid immunoassay read by an instrument (Sofia Analyzer), not an imaging device typically associated with MRMC studies involving human readers.
6. Standalone Performance:
Yes, standalone performance was assessed. The entire document describes the performance of the Sofia hCG FIA algorithm (via the Sofia Analyzer) in various analytical and clinical studies, independent of human interpretation or intervention in the diagnostic process beyond specimen collection and loading the cassette. The Sofia Analyzer dictates the development time, scans the strip, and analyzes the fluorescent signal using method-specific algorithms to display the result (Positive, Negative, or Invalid).
7. Type of Ground Truth Used:
- Analytical Performance Studies (Reproducibility, Detection Limit, High-Dose Hook Effect, Analytical Specificity): The ground truth was established using known, contrived samples prepared by spiking negative urine with specific, traceable concentrations of hCG (WHO International 4th Standard) or other substances.
- Clinical Performance Study: The ground truth was based on the results obtained from another commercially available qualitative test when evaluating clinical patient samples.
8. Sample Size for the Training Set:
The document does not explicitly state a separate "training set" for the Sofia hCG FIA. As a lateral flow immunoassay read by an analyzer with method-specific algorithms, the "training" would likely refer to the data used during the development and optimization of the instrument's algorithm and the assay reagents themselves. This information is not provided in detail, as the focus is on the validation performance of the finished product.
9. How Ground Truth for Training Set was Established:
As mentioned above, a "training set" is not explicitly described. However, during the development of such a device, a vast number of samples with known hCG concentrations (established through analytical methods, often traceable to international standards) would be used to develop and refine the detection algorithms and thresholds for the Sofia Analyzer. This would involve rigorous calibration and optimization to correctly identify positive and negative results across the intended range of hCG concentrations and ensure specificity. The performance studies detailed in the submission serve as the validation of this developed system.
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