(89 days)
VITROS® Troponin I ES Reagent Pack:
For in vitro diagnostic use only.
For the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA) using the VITROS Immunodiagnostic System, to aid in the assessment of myocardial damage and risk stratification.
Cardiac Troponin I measurement aids in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST-segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures.
VITROS® Troponin I ES Calibrators:
For in vitro diagnostic use only.
For use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of cardiac Troponin I (cTnI) in human serum and plasma (heparin and EDTA).
VITROS® Troponin I ES Range Verifiers:
For in vitro diagnostic use only.
For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the quantitative measurement of cardiac Troponin I (cTnI).
- The VITROS Immunodiagnostic Products range of immunoassav products: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack, the VITROS Immunodiagnostic Products Troponin I ES Calibrators and the VITROS Immunodiagnostic Products Troponin I ES Range Verifiers, (which are combined by the VITROS Immunodiagnostic System to perform the VITROS Troponin I ES assay), and VITROS Immunodiagnostic Products High Sample Diluent B.
- The VITROS Immunodiagnostic System: Instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- Common reagents used by the VITROS System in each assay: The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).
Note: High Sample Diluent B was cleared as part of the VITROS Immunodiagnostic Products Total ß-hCG Reagent Pack and VITROS Immunodiagnostic Products Total ß-hCG Calibrators 510(k) premarket notification (K970894).
The VITROS Immunodiagnostic System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.
This 510(k) summary describes the VITROS® Immunodiagnostic Products Troponin I ES Reagent Pack, Calibrators, and Range Verifiers, designed for the quantitative measurement of cardiac Troponin I (cTnI). The submission aims to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the new device are implied by a comparison to a predicate device (BECKMAN Access® AccuTnI Troponin I assay) and various clinical and analytical standards. The document primarily focuses on establishing "substantial equivalence" rather than specific numerical acceptance criteria for each performance characteristic. However, the listed "Differences" section in Table 1 can be interpreted as the reported device performance compared to specific characteristics of the predicate.
| Characteristic | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (VITROS Troponin I ES) |
|---|---|---|
| Intended Use | Similar to predicate | For quantitative measurement of cTnI in human serum and plasma (heparin and EDTA) to aid in assessment of myocardial damage and risk stratification. Aids in diagnosis of acute MI and risk stratification of non-ST-segment elevation acute coronary syndromes. |
| Basic Principle | Chemiluminescence Immunoassay | Solid phase immunoassay (Note: Predicate is 2-site immunoenzymatic, both are chemiluminescence) |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | Automated Immunoassay System | Automated Immunoassay System |
| Antibody | Mouse monoclonal | Mouse monoclonal |
| Sample Type | Serum and plasma (heparin and EDTA) | Serum and plasma (heparin and EDTA) |
| Organizations Used/Referenced | NACB, ESC/ACC/AHA, WHO | NACB, ESC/ACC/AHA, WHO |
| Lower Limit of Detection | Generally acceptable sensitivity | 0.012 ng/mL (Note: Predicate "Not applicable" for this specific metric) |
| Sample Volume | Not explicitly defined as acceptance criteria for new device, but a comparative point of difference. | 80 µL |
| Measuring Range | Broad enough for clinical utility | 0.012-80.0 ng/mL |
| Analytical Sensitivity | Comparable to predicate |
§ 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.