ELITECH CLINICAL SYSTEMS CK NAC SL

K122083 · Elitechgroup · JHW · Aug 22, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122083
• Device Name: ELITECH CLINICAL SYSTEMS CK NAC SL
• Applicant: Elitechgroup
• Product Code: JHW · Clinical Chemistry
• Decision Date: Aug 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2
• Attributes: Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K122083 · Aug 22, 2012	ELITECH CLINICAL SYSTEMS CK NAC SL	Elitechgroup	Patient serum samples; Paired serum and plasma samples	Patient samples were used to perform method comparison and matrix comparison studies to demonstrate substantial equivalence to the predicate device.	Method comparison; Matrix comparison; Patient samples

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Method comparison study; Follow-up/Duration: 5 days	Patient serum samples; Sample Size: 100	Roche Diagnostics CKL reagent on a cobas c111 analyzer	Correlation and bias estimation
Matrix comparison study	Paired serum and plasma (lithium heparin) samples; Sample Size: 40	Not applicable for this study	Regression analysis

Indications for Use

ELITech Clinical Systems CK NAC SL is intended for the quantitative in vitro determination of creatine kinase (CK) in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Creatine phosphokinase and its isoenzymes measurements are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Device Story

CK NAC SL is an in vitro diagnostic reagent kit for quantitative measurement of creatine kinase (CK) activity in human serum and plasma. Used on ELITech Clinical Systems Selectra analyzers in clinical laboratory settings by trained personnel. Principle of operation: kinetic UV method; CK catalyzes conversion of creatine phosphate and ADP to creatine and ATP; subsequent enzymatic reactions involving hexokinase and G-6-PDH produce NADPH; increase in NADPH concentration is directly proportional to CK activity. Output is a quantitative measurement of CK activity (U/L). Results assist clinicians in diagnosing and monitoring myocardial infarction and muscle diseases. Device includes calibrator (ELICAL 2) and controls (ELITROL I/II) to ensure accuracy and precision.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (n=80, CV% 0.7-3.9%). Linearity established per CLSI EP6-A (10-1714 U/L). LoD/LoQ determined per CLSI EP17-A (1 U/L and 5 U/L respectively). Interference testing per CLSI EP7-A2 showed no significant interference for bilirubin, triglycerides, acetaminophen, ascorbic acid, or acetylsalicylic acid. Method comparison study (n=100) against Roche CKL yielded y = 1.012x + 2, r=0.998. Matrix comparison (serum vs plasma) yielded r=1.000.

Technological Characteristics

Reagents: Imidazole buffer, D-Glucose, N-Acetyl-L-Cysteine, Magnesium acetate, NADP, EDTA, Hexokinase, G-6-PDH, sodium azide. Kinetic UV method. Analyzers: Selectra ProM. Calibration: 28-day frequency. Calibrator/Controls: Lyophilized human serum-based. Connectivity: Standalone analyzer system.

Indications for Use

Indicated for quantitative in vitro determination of creatine kinase (CK) in human serum and plasma to aid in diagnosis and treatment of myocardial infarction and muscle diseases (e.g., Duchenne-type muscular dystrophy). Not for Point of Care use.

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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# Decision Summary

Statement for the Record, k122083

This 510(k) was reviewed under OIVD’s Pilot Triage 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.