ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
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 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K122858 · Oct 3, 2012 | ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II | Elitechgroup | Retrospective patient serum and plasma samples | Retrospective patient samples were used to perform method comparison and bias estimation studies between the candidate device and the predicate device to support substantial equivalence. | Method comparison; Patient samples; Analytical validation |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Method comparison study; Follow-up/Duration: 5 days | Patient serum samples; Sample Size: 100 | Roche Diagnostics AMYL2 (α-Amylase EPS ver.) | Correlation and bias estimation |
| Method comparison study | Paired plasma (lithium heparin) samples; Sample Size: 48 | Not applicable for this study | Regression analysis |
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).
