← Back to catalogue

Elitech Clinical Systems Elical 2 +1 more model

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130765

by Elitechgroup

Identifiers

510(k) Number
K130765 FDA 510(k)
FDA Product Code
JIX FDA 510(k)
Models / Variants
Elitech Clinical Systems Elical 2 FDA 510(k)
Elitech Clinical Systems Elitrol I, Elitech Clinical Systems Elitrol Ii FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1150 FDA 510(k)
Regulation Number
862.1150 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ELITECH CLINICAL SYSTEMS ELICAL 2 is a multi-parametric calibrator, while ELITROL I and ELITROL II are two-level quality control sera. These are lyophilized human serum-based products used to calibrate and monitor quantitative clinical chemistry assays on ELITech Selectra analyzers in clinical laboratories.

The devices are supplied for use with ELITech Clinical Systems Selectra Pro Series Analyzers. They are sourced from a commercial vendor and re-labeled. The ELICAL 2 ensures accurate system calibration, while the ELITROL I and II verify assay performance. The device is authorized under FDA 510K with product code JIX.

Frequently asked questions

What is the purpose of the ELITECH CLINICAL SYSTEMS ELICAL 2 and ELITROL I II?

The ELICAL 2 is a multi-parametric calibrator used to ensure accurate system calibration, while ELITROL I and II are two-level quality control sera that verify assay performance on ELITech Selectra analyzers in clinical laboratories.

How are the ELITECH CLINICAL SYSTEMS ELICAL 2 and ELITROL I II supplied?

These devices are lyophilized human serum-based products supplied for use with ELITech Clinical Systems Selectra Pro Series Analyzers. They are sourced from a commercial vendor and re-labeled for specific laboratory use.

Are the ELITECH CLINICAL SYSTEMS ELICAL 2 and ELITROL I II single-use or reusable products?

The device information does not specify whether these products are single-use or reusable. The ELICAL 2 is used for calibration while ELITROL I and II are used for quality control, but the exact usage instructions regarding single-use or reuse are not provided in the available data.

What is the regulatory status of the ELITECH CLINICAL SYSTEMS ELICAL 2 and ELITROL I II?

The devices are authorized under FDA 510K with product code JIX. They are classified as substantially equivalent devices for clinical chemistry applications, with the review advisory committee being CH (Clinical Chemistry).

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I ..., Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I ..., Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol I ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Elitechgroup

Sources (1)

  • FDA 510(k) K130765 24 fields · synced Sep 21, 2026