(83 days)
The QUANTA Lite™ SLA (soluble liver antigen) kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-SLA (soluble liver antigen) antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AIH).
The QUANTA Lite™ SLA (soluble liver antigen) kit is an enzyme-linked immunosorbent assay (ELISA).
This document is a 510(k) clearance letter from the FDA for the QUANTA Lite™ SLA ELISA device, not a study report. Therefore, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving device performance as it would typically be found in a clinical study report or a 510(k) summary.
However, based on the provided text, I can extract some relevant information and highlight what is missing.
Information Extracted from the Document:
- Device Name: QUANTA Lite™ SLA (Soluble Liver Antigen) ELISA
- Intended Use: Semi-quantitative detection of anti-SLA (soluble liver antigen) antibody of the IgG class in human serum, intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AIH).
Missing Information (and why it's missing from this type of document):
This letter is an FDA clearance, which means the manufacturer submitted data in their 510(k) application demonstrating substantial equivalence to a predicate device. The detailed study results, acceptance criteria, sample sizes, ground truth establishment, etc., would be in the 510(k) Summary or the full 510(k) submission, which is not provided here.
Therefore, I cannot populate the table or answer most of the specific questions.
Placeholder for Answer Structure, if the full 510(k) Summary were available:
Here's how I would structure the answer if the required information were present:
1. Table of Acceptance Criteria and Reported Device Performance
(This would typically outline performance metrics like Sensitivity, Specificity, Agreement with a predicate device, Precision, etc., and the thresholds set for acceptance.)
| Acceptance Criteria Metric | Acceptance Threshold | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Sensitivity | [e.g., > 90%] | [e.g., 92.5%] | Yes |
| Specificity | [e.g., > 95%] | [e.g., 96.8%] | Yes |
| Positive Agreement | [e.g., > 90%] | [e.g., 91.2%] | Yes |
| Negative Agreement | [e.g., > 90%] | [e.g., 95.5%] | Yes |
| Overall Agreement | [e.g., > 90%] | [e.g., 93.4%] | Yes |
| Intra-Assay Precision | [e.g., CV |
§ 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).