(270 days)
Access hsTnl is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI).
The Access hsTnl and Access UniCel Dxl 800 Immunoassay System comprise the Access Immunoassay System for the quantitative determination of cardiac troponin I (cTnl) in human serum and plasma. The Access hsTnl reagent packs contain specific reagents for the in vitro diagnostic measurement of cTnl including: R1a: Dynabeads* paramagnetic particles coated with mouse . monoclonal anti-human cTnl antibody suspended in TRIS buffered saline, with surfactant, bovine serum albumin (BSA).
The Access hsTnI device is an immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma to aid in the diagnosis of myocardial infarction (MI). The study to prove the device meets acceptance criteria involved establishing the 99th percentile Upper Reference Limit (URL) in a healthy population and evaluating clinical performance (diagnostic accuracy) in patients presenting with chest pain or symptoms suggestive of Acute Coronary Syndromes (ACS).
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (New Device: Access hsTnI) | Predicate Device Performance (Access AccuTnl+3) | Reported Device Performance (Access hsTnI) |
|---|---|---|---|
| Intended Use/ | |||
| Indications for Use | Aid in the diagnosis of myocardial infarction (MI) | Aid in the diagnosis of myocardial infarction | Aid in the diagnosis of myocardial infarction (MI) |
| Assay Principle | Chemiluminescent sandwich immunoassay | Chemiluminescent sandwich immunoassay | Same |
| Test System | Automated immunoassay instrument | Automated immunoassay instrument | Same |
| Sample Type | Serum and heparinized plasma | Serum and heparinized plasma | Same |
| Reagent Pack configuration | Reagents ready to use and separated in a single reagent pack | Reagents ready to use and separated in a single reagent pack | Same |
| Primary Reagent Materials | Dynabeads paramagnetic particles coated with mouse monoclonal anti-human cTnI antibody | Solid phase magnetic particles, anti-cTnI antibodies | Dynabeads paramagnetic particles coated with mouse monoclonal anti-human cTnI antibody |
| Sample Volume | 55µl | 55µl | Same |
| Specific Reagent Materials | Sheep monoclonal anti-human cTnI alkaline phosphatase conjugate diluted in ACES buffered saline, with surfactant, BSA matrix, protein (bovine, sheep, mouse) | Mouse monoclonal anti-human cTnI alkaline phosphatase conjugate, magnetic particles coated with mouse monoclonal anti-human cTnI | Sheep monoclonal anti-human cTnI alkaline phosphatase conjugate diluted in ACES buffered saline, with surfactant, BSA matrix, protein (bovine, sheep, mouse) |
| Immunoassay Instrument | UniCel DxI 800 Access Immunoassay System | Access 2 Immunoassay System | UniCel DxI 800 Access Immunoassay System |
| Analytical Measuring Range | 2.1 pg/mL to 27,027 pg/mL | 0.02 ng/mL to 100 ng/mL (20 pg/mL to 100,000 pg/mL) | 2.1 pg/mL to 27,027 pg/mL |
| Expected Results (Upper Reference Limit) | 99th percentile of 17.9 pg/mL (Overall Lithium Heparin Plasma), 18.1 pg/mL (Overall Serum) | 99th percentile of 0.02 with a 95% Confidence Interval (CI) of 0.01-0.05 ng/mL | 99th percentile of 17.9 pg/mL (95% CI: 14.7-27.1) for Lithium Heparin Plasma |
| 99th percentile of 18.1 pg/mL (95% CI: 14.3-25.6) for Serum | |||
| Precision | ≤ 10% within-laboratory CV for concentrations ≥ 11.5 pg/mL, ≤ 1.15 pg/mL within-laboratory SD for concentrations 0.075 ng/mL. SD ≤0.006 at concentrations ≤0.075 ng/mL | Within-laboratory (total) %CV: 2.8% to 10% for ≥ 11.5 pg/mL, SD: 0.22 to 0.75 for 11.5 pg/mL, 11.5 pg/mL, 11.5 pg/mL, 11.5 pg/mL, |
§ 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.