ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
Device Facts
| Record ID | K130765 |
|---|---|
| Device Name | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II |
| Applicant | Elitechgroup |
| Product Code | JIX · Clinical Chemistry |
| Decision Date | Apr 4, 2013 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
Indications for Use
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Analyzers. ELITech Clinical Systems ELITROL I and ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on EliTech Clinical Systems Selectra Analyzers.
Device Story
ELICAL 2 and ELITROL I/II are lyophilized human serum-based products used for calibration and quality control of quantitative assays on ELITech Clinical Systems Selectra Analyzers. ELICAL 2 provides calibration for quantitative methods; ELITROL I and II serve as multi-parametric controls to monitor accuracy and precision. Used in clinical laboratory settings by trained laboratory personnel. The calibrator and controls are reconstituted with distilled/deionized water. Healthcare providers use the resulting calibration and control data to ensure the accuracy of patient sample testing performed on the Selectra analyzers. These products help maintain the reliability of diagnostic results, supporting clinical decision-making by ensuring the analytical system is performing within established specifications.
Clinical Evidence
Bench testing only. Evidence includes value assignment verification for lipase, where target values were verified by calibrating the test system using previously qualified lots and measuring lipase levels. Acceptance criteria required values to be within ±9% of the target. Stability data for lyophilized and reconstituted states (including bilirubin exceptions) were compared to predicates.
Technological Characteristics
Lyophilized human serum-based calibrator and control sera. Prepared from human donor blood tested negative for HbsAg, HCV, and HIV. Reconstituted with distilled/deionized water. Designed for use on ELITech Clinical Systems Selectra Analyzers. Stability profiles provided for various temperature ranges (15-25°C, 2-8°C, -25 to -15°C).
Indications for Use
Indicated for in vitro diagnostic use as a multi-parametric calibrator (ELICAL 2) and quality control sera (ELITROL I and II) for quantitative ELITech Clinical Systems methods on Selectra analyzers. No specific patient population, age, or gender restrictions are defined.
Regulatory Classification
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Related Devices
- K151552 — ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II · Elitechgroup · Jul 8, 2015
- K112029 — ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 · Elitechgroup · Aug 30, 2011
