(43 days)
This is an enzyme immunoassay test system for the detection of antibodies to myeloperoxidase (MPO) in human serum. This test system is to be used as an aid in the detection of antibodies associated with microscopic polyangiitis, idiopathic necrotizing and crescentic glomerulonephritis, and other vasculitides.
This is an enzyme immunoassay for the detection of antibodies to myeloperoxidase (MPO) in human serum.
Here's an analysis of the provided information regarding the Immuno Concepts RELISA® MPO-ANCA Test System:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the FDA's "substantial equivalence" determination, meaning the new device's performance should be comparable to the legally marketed predicate device. While explicit numerical acceptance criteria aren't listed, the study demonstrates performance relative to the predicate device.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (Immuno Concepts RELISA® MPO) |
|---|---|---|
| Relative Sensitivity | Comparable to Predicate Device | 96.4% |
| Relative Specificity | Comparable to Predicate Device | 94.6% |
| Overall Agreement | Comparable to Predicate Device | 94.7% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 818 samples were used for the test set. Breakdown:
- 208 samples submitted to clinical laboratories for ANCA, MPO, and PR3 testing (without specific diagnoses).
- 7 samples from patients with a diagnosis of Churg-Strauss syndrome.
- 18 patients with a diagnosis of vasculitis.
- 25 patients with a diagnosis of Wegener's granulomatosis.
- 261 samples from male blood donors.
- 239 samples from female blood donors.
- Data Provenance: The document does not explicitly state the country of origin for all samples. However, the predicate device is manufactured in Birmingham, England, UK. The source of the 208 clinical samples is general ("clinical laboratories"), suggesting a broader geographic origin, potentially US. The studies are retrospective, as the samples were "submitted to clinical laboratories" or from patients with existing diagnoses, and then tested in parallel.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" as typically established by expert consensus (e.g., radiologists interpreting images) isn't directly applicable here in the same way. For this immunoassay, the "ground truth" for the test set is established by the performance of the predicate device, the Bindazyme™ Anti-MPO Enzyme Immunoassay Kit. The predicate device itself has been legally marketed and its performance implicitly accepted.
The document indicates that for the "false positive" samples identified by the new device, further investigation involved immunofluorescence (P-ANCA pattern). This suggests a second-level diagnostic assessment, but it's not described as an "expert panel" establishing the initial ground truth for the entire sample set.
Therefore, the number and qualifications of experts for establishing ground truth for the entire test set are not explicitly stated as it relies on the predicate device's results.
4. Adjudication Method for the Test Set
The primary "adjudication method" for the test set is direct comparison to the predicate device. Both the Immuno Concepts RELISA® MPO-ANCA Test System and the Bindazyme™ Anti-MPO Enzyme Immunoassay Kit were run in parallel on all 818 samples. Discrepancies were then noted.
For the 38 "false positive" samples (where the new device was positive and the predicate was negative), additional immunofluorescence testing was performed. However, this was for analysis of discrepancies rather than a primary adjudication method for establishing the initial ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not conducted. This type of study involves multiple human readers interpreting cases and comparing their performance with and without AI assistance. The described study is a direct comparison of a new immunoassay device (Immuno Concepts RELISA® MPO-ANCA) against a legally marketed predicate immunoassay device (Bindazyme™ Anti-MPO Enzyme Immunoassay Kit). It does not involve human readers interpreting "cases" in the typical sense of imaging or clinical diagnostics.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done. The Immuno Concepts RELISA® MPO-ANCA Test System was run independently on all samples, and its results were then compared to the results of the predicate device, which also ran independently. There was no human interpretation or interaction with the device's output influencing the reported performance metrics (sensitivity, specificity, agreement). The device's output for each sample was a positive or negative result.
7. Type of Ground Truth Used
The primary "ground truth" used for this study is the results obtained from the legally marketed predicate device (Bindazyme™ Anti-MPO Enzyme Immunoassay Kit). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices where a new device is compared against an established, validated method. For discrepant results, some additional immunofluorescence testing was used as a secondary method of investigation.
8. Sample Size for the Training Set
The document does not provide information on a training set. This type of 510(k) submission focuses on the performance of a final, manufactured device. If the Immuno Concepts RELISA® MPO-ANCA Test System involved machine learning or an "algorithm" in a development phase, details of its training set would typically be described during its initial development, not necessarily in this specific regulatory submission which focuses on the final product's comparison to a predicate. It's likely that this immunoassay kit does not involve a machine learning algorithm in the sense of needing a "training set" for model development; rather, it's a biochemical assay for which performance characteristics are established via testing.
9. How the Ground Truth for the Training Set Was Established
As no training set is described (see point 8), this information is not applicable or provided in the document.
§ 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).