ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY

K132571 · Roche Diagnostics · JHY · Oct 18, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132571
• Device Name: ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY
• Applicant: Roche Diagnostics
• Product Code: JHY · Clinical Chemistry
• Decision Date: Oct 18, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase in human serum and plasma. Measurements of the MB isoenzyme of creatinine kinase are used as an aid in the diagnosis of myocardial infarction. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

The Elecsys CK-MB STAT and CK-MB immunoassays are two-step sandwich immunoassays utilizing streptavidin-coated microparticles and electrochemiluminescence (ECLIA) detection. The device processes human serum or plasma samples (15 µL) on Roche cobas e 411 analyzers. During the first incubation, biotinylated monoclonal anti-CK-MB antibodies and ruthenium-labeled monoclonal CK-MB-specific antibodies form a sandwich complex with the analyte. In the second incubation, streptavidin-coated microparticles bind the complex to the solid phase. The analyzer measures the electrochemiluminescent signal, which is proportional to the CK-MB concentration. Results are calculated via a 2-point calibration against a master curve provided by the reagent barcode. The device is used in clinical laboratory settings by trained technicians to aid in the diagnosis of myocardial infarction. The output provides quantitative CK-MB levels, which clinicians use in conjunction with patient history and other clinical findings to assess cardiac health.

Clinical Evidence

Bench testing only. Performance validated per CLSI guidelines. Precision testing (21 days) showed total CVs ranging from 2.0% to 4.2% across the measuring range (1-300 ng/mL). Analytical sensitivity: LoB=0.1 ng/mL, LoD=0.3 ng/mL, LoQ=1 ng/mL. Method comparison (n=165) against predicate yielded a slope of 1.053 and r=0.982. Matrix equivalence studies confirmed recovery for various anticoagulants (Na-heparin, Li-heparin, K2/K3-EDTA). No interference found for common pharmaceuticals or endogenous substances (hemoglobin, bilirubin, lipids, biotin, RF, immunoglobulins) within specified limits.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence (ECLIA) detection; streptavidin-coated microparticles; biotinylated and ruthenium-labeled monoclonal antibodies. Measuring range: 1-300 ng/mL. Sample volume: 15 µL. Platform: cobas e 411 analyzer. Calibration: 2-point calibration with master curve. Traceability: Abbott IMx CK-MB assay. Standards: CLSI EP5-A2, EP17-A, EP6-A. Sterilization: Not applicable (reagent).

Indications for Use

Indicated for in vitro quantitative determination of MB isoenzyme of creatine kinase in human serum and plasma as an aid in the diagnosis of myocardial infarction. For prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k132571

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.