ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT

K141265 · Elitechgroup · JHW · Jul 18, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141265
• Device Name: ELITECH CLINICAL SYSTEMS ENVOY 500 CK REAGENT KIT
• Applicant: Elitechgroup
• Product Code: JHW · Clinical Chemistry
• Decision Date: Jul 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

ENVOY®500 CK REAGENT KIT is intended for the quantitative in vitro determination of creatine kinase (CK) in human serum and plasma using the ENVOY 500 Chemistry System. 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

The ENVOY 500 CK Reagent Kit is an in vitro diagnostic reagent used on the ENVOY 500 Chemistry System to measure creatine kinase (CK) activity in human serum and plasma. The device utilizes a kinetic UV method based on IFCC recommendations; the assay involves a series of enzymatic reactions where CK catalyzes the conversion of creatine phosphate and ADP to creatine and ATP, followed by hexokinase and G-6-PDH reactions to produce NADPH. The rate of increase in NADPH absorbance at 340 nm is measured by the analyzer and is directly proportional to CK activity. The system is intended for use in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and monitoring myocardial infarction and muscle diseases. The kit is provided as a ready-to-use liquid bi-reagent.

Clinical Evidence

Bench testing only. Performance was validated through precision studies (within-run CV 1.0-1.5%, total CV 3.5-3.6%), linearity (10-1714 U/L), and interference testing (no significant interference from hemoglobin, bilirubin, triglycerides, ascorbic acid, acetylsalicylic acid, or acetaminophen). Method comparison against the predicate using 100 serum samples yielded y = 1.050x + 0 U/L (r=0.998). Plasma sample validation (n=40) yielded y = 1.020x + 3 U/L (r=0.999).

Technological Characteristics

Liquid bi-reagent kit containing imidazole buffer, D-glucose, N-acetyl-L-cysteine, magnesium acetate, NADP, EDTA, hexokinase, G-6-PDH, and sodium azide. Kinetic UV assay principle. Measures absorbance at 340 nm. On-board stability: 28 days. Storage: 2-8 °C. Standalone reagent kit for use on the ENVOY 500 Analyzer.

Indications for Use

Indicated for the quantitative in vitro determination of creatine kinase (CK) in human serum and plasma for the diagnosis and treatment of myocardial infarction and muscle diseases (e.g., Duchenne-type muscular dystrophy). Not for Point of Care settings. 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) #: k141265

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.