← Product Code [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX) · K151552

# ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II (K151552)

_Elitechgroup · JIX · Jul 8, 2015 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K151552

## Device Facts

- **Applicant:** Elitechgroup
- **Product Code:** [JIX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX.md)
- **Decision Date:** Jul 8, 2015
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 862.1150
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## 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 Pro Series Analyzers. ELITech Clinical Systems ELITROL I & 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 Pro Series Analyzers.

## Device Story

ELICAL 2 and ELITROL I/II are lyophilized human serum-based products used for calibration and quality control of clinical chemistry assays. ELICAL 2 serves as a multi-parametric calibrator; ELITROL I and II serve as two-level quality control sera. Used in clinical laboratories on ELITech Clinical Systems Selectra Pro Series Analyzers. Operators are trained laboratory professionals. The device is reconstituted with distilled/deionized water. Calibration values are assigned by testing against reference materials on Selectra analyzers; control values are assigned via multi-day triplicate testing. Healthcare providers use the calibrator to establish assay accuracy and the control sera to monitor precision and accuracy of patient sample testing. Proper calibration and control ensure reliable quantitative results for clinical decision-making, benefiting patients through accurate diagnostic testing.

## Clinical Evidence

Bench testing only. Performance data established through value assignment protocols on Selectra ProM and ProS analyzers. Calibration values assigned based on mean of 48 measurements against reference materials. Control values assigned via triplicate testing over several days to determine median and confidence ranges. No clinical patient data included.

## Technological Characteristics

Lyophilized human serum-based calibrator and control sera. Reconstituted with distilled/deionized water. Multi-parametric composition. Stability varies by analyte (e.g., bilirubin exceptions). Designed for use on ELITech Clinical Systems Selectra Pro Series Analyzers. No electronic components or software algorithms integral to the calibrator/control products themselves.

## Regulatory 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.

## Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k151552

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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K151552](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIX/K151552)

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