(270 days)
Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access 2 Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI).
The Access hsTnI is a two-site immunoenzymatic ("sandwich") assay. Monoclonal anti-cTnl antibody coniugated to alkaline phosphatase is added to a reaction vessel along with a surfactant-containing buffer and sample. After a short incubation, paramagnetic particles coated with monoclonal anti-cTnl antibody are added. The human cTnl binds to the anti-cTnl antibody on the solid phase, while the anti-cTnl antibody-alkaline phosphatase conjugate reacts with different antigenic sites on the cTnl molecules. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
Here's a breakdown of the acceptance criteria and study details for the Access hsTnI device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance (Candidate) |
|---|---|---|
| Precision | ≤ 10% within-laboratory CV for concentrations ≥ 11.5 pg/mL ≤ 1.15 pg/mL within laboratory SD for concentrations 0.05), or if significant, bias ≤ 10% across the analytical measuring range. | |
| LoB (Limit of Blank) | Not explicitly stated as a numerical criterion in the "Predicate" column. | 0.6 pg/mL |
| LoD (Limit of Detection) | Not explicitly stated as a numerical criterion in the "Predicate" column. | 1.0 pg/mL (serum) and 0.6 pg/mL (plasma) |
| LoQ (Limit of Quantitation) | Not explicitly stated as a numerical criterion in the "Predicate" column. | 0.8 pg/mL (serum) and 0.7 pg/mL (plasma) at ≤20% within-lab CV |
| Carryover | Not explicitly stated as a numerical criterion in the "Predicate" column. | ≥ 95% of maximum individual replicate carryover events |
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.