ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II

K122858 · Elitechgroup · JFJ · Oct 3, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122858
• Device Name: ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
• Applicant: Elitechgroup
• Product Code: JFJ · Clinical Chemistry
• Decision Date: Oct 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1070
• Device Class: Class 2

Indications for Use

ELITech Clinical Systems AMYLASE SL is intended for the quantitative in vitro determination of amylase in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Measurements of amylase are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Device Story

ELITech Clinical Systems AMYLASE SL is an in vitro diagnostic reagent kit for measuring amylase activity in human serum and plasma. The device uses an enzymatic method where the substrate CNP-G3 is hydrolyzed by amylase to produce CNP. The rate of increase in absorbance at 405 nm is measured on ELITech Clinical Systems Selectra analyzers; this rate is directly proportional to amylase activity. The system includes ELICAL 2 (calibrator) and ELITROL I/II (control sera). The device is used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and monitoring pancreatitis. The system provides quantitative data to support clinical decision-making regarding pancreatic inflammation.

Clinical Evidence

Bench testing only. Performance validated per CLSI guidelines (EP5-A2, EP6-A, EP17-A, EP7-A2, EP9-A2). Precision: Total CV% 2.2-2.7%. Linearity: 20-1500 U/L. LoD: 6 U/L; LoQ: 13 U/L. Method comparison (n=100) vs. Roche AMYL2 yielded y = 0.976x - 1, r=0.999. Plasma comparison (n=48) yielded y = 0.907x + 1, r=1.000. No significant interference from bilirubin, triglycerides, hemoglobin, acetaminophen, ascorbic acid, or acetylsalicylic acid at tested concentrations.

Technological Characteristics

Enzymatic assay using CNP-G3 substrate. Reagent composition: MES buffer (pH 6.15), NaCl, CaCl2, potassium thiocyanate, CNP-G3, sodium azide. Lyophilized human serum-based calibrators and controls. Photometric detection at 405 nm. Designed for use on Selectra ProM analyzers. No software algorithm class specified; standard clinical chemistry photometric analysis.

Indications for Use

Indicated for the quantitative in vitro determination of amylase in human serum and plasma to aid in the diagnosis and treatment of pancreatitis. Not for Point of Care use. Prescription use only.

Regulatory Classification

Identification

An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

Submission Summary (Full Text)

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# Decision Summary

Statement for the Record, k122858

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.