(105 days)
An indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum to aid in the diagnosis of patients with necrotizing vasculitides.
This assay is an indirect immunofluorescence antibody test for the detection and semi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) in human serum.
Here's a breakdown of the acceptance criteria and study details for the IMMCO Diagnostics ImmuGlo™ ANCA Test System, based on the provided 510(k) notification:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (IMMCO ImmuGlo™ ANCA Test System) |
|---|---|
| Relative Specificity: Not explicitly stated, but derived from predicate's performance against ground truth (assuming 100% sensitivity for predicate against its own ground truth from clinical test data, Scimedx: 73 true negative out of 73 total negative samples) | 91% (calculated from the comparative study with Scimedx: 73 true negative / (73 true negative + 7 false positive) |
| Relative Sensitivity: Not explicitly stated, but derived from predicate's performance against ground truth (assuming 100% sensitivity for predicate against its own ground truth from clinical test data, Scimedx: 49 true positive out of 49 total positive samples) | 100% (calculated from the comparative study with Scimedx: 49 true positive / (49 true positive + 0 false negative) |
| Relative Agreement: Not explicitly stated for predicate in a standalone table, but likely expected to be high | 95% (calculated from the comparative study with Scimedx: (49 true positive + 73 true negative) / 129 total samples) |
Note: The acceptance criteria are implicitly based on the performance of the predicate device (Scimedx) to demonstrate substantial equivalence. The document doesn't explicitly state numerical acceptance criteria before showing the results, but rather presents the results against the predicate and concludes substantial equivalence.
Study Proving Device Meets Acceptance Criteria
2. Sample Size and Data Provenance:
* Test Set Sample Size: 129 samples.
* Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective as it compares IMMCO's test performance against a predicate device on a fixed set of samples.
3. Number of Experts and Qualifications for Ground Truth:
* Number of Experts: Not specified.
* Qualifications of Experts: Not specified. However, the initial comparison uses a legally marketed predicate device (Scimedx Corporation's ANCA Test System) as the reference, which implies established clinical accuracy. For discrepant samples, ELISA for MPO or PR3 antigens (two major ANCA antigens) was used, which typically involves laboratory testing performed by qualified personnel.
4. Adjudication Method for Test Set:
* Adjudication Method: Not explicitly detailed for the primary comparison. The comparison is a direct concordance study between the IMMCO device and the Scimedx predicate device.
* For the 7 discrepant samples (IMMCO positive, Scimedx negative), ELISA for MPO or PR3 antigens was used. This acts as a secondary, more specific adjudication method, confirming the "true positivity" for 6 out of these 7 samples.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* No, a MRMC comparative effectiveness study was not done. This evaluation focuses on the performance of an in-vitro diagnostic test system, which does not involve human readers interpreting images or results in the same way an imaging AI would. The comparison is between two commercial assay systems.
6. Standalone Performance:
* Yes, a standalone performance was done, in the sense that the IMMCO device's results were generated independently on the 129 samples, and then compared to the results from the Scimedx device on the same samples. The reported "Relative Specificity," "Relative Sensitivity," and "Relative Agreement" are metrics of its performance compared to the predicate device.
7. Type of Ground Truth Used:
* The primary "ground truth" for the main comparison was the results from a legally marketed predicate device (Scimedx ANCA Test System).
* For the 7 discrepant samples, the "ground truth" was established by ELISA results for MPO or PR3 antigens (pathology/laboratory testing).
8. Sample Size for the Training Set:
* Not applicable. This document describes a traditional in-vitro diagnostic assay comparison, not an AI/machine learning device. Therefore, there is no "training set" in the context of algorithm development. The device itself is a laboratory kit.
9. How Ground Truth for Training Set Was Established:
* Not applicable. As above, there is no training set for this type of device.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).