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510(k) Data Aggregation
(220 days)
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
The Axis Homocysteine Enzyme Immunoassay is intended for the quantitative measurement of total L-homocysteine in human serum or plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocysteinuria.
The Axis Homocysteine Enzyme Immunoassay is designed for the quantitative determination of total homocysteine in plasma or serum. In the Axis Homocysteine Enzyme Immunoassay, protein bound homocysteine is reduced to free homocysteine, enzymatically converted to S-adenosyl-L-homocysteine (SAH), and detected in competitive immunoassay with monoclonal anti-SAH antibody.
The Axis Homocysteine Enzyme Immunoassay (Axis Homocysteine EIA) underwent an evaluation to establish its substantial equivalence to an existing device, the University of Bergen Homocysteine by HPLC method, and thus confirm its safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Device Performance) | Axis Homocysteine Enzyme Immunoassay Performance |
|---|---|---|
| Precision | ||
| - Within-run %CV (Low) | Similar to or better than predicate | 7.3% |
| - Within-run %CV (Medium) | Similar to or better than predicate | 6.8% |
| - Within-run %CV (High) | Similar to or better than predicate | 5.2% |
| - Total precision (Low) | Similar to or better than predicate | 9.3% |
| - Total precision (Medium) | Similar to or better than predicate | 8.1% |
| - Total precision (High) | Similar to or better than predicate | 7.1% |
| Measuring Range | Not explicitly stated, but within clinically relevant range | 2 - 50 µmol/L |
| Limit of Quantification | Not explicitly stated, but clinically acceptable |
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