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Glucose Pap Sl, Elical 2, Elitrol 1 and 2

by Seppim S.A.S.

510(k) K100525

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK100525 Date15 Dec 2010ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0217-2016 FDA Class II initiated 22 Sep 2015

    ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received.

    • Terminated Z-0214-2016 FDA Class II initiated 22 Sep 2015

    ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received.

    • Terminated Z-0216-2016 FDA Class II initiated 22 Sep 2015

    ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received.

    • Terminated Z-0215-2016 FDA Class II initiated 22 Sep 2015

    ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system are recalled due to potential drug interference. No complaints were received.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Elitech Clinical Systems Glucose Pap Sl Elitech Clinical Systems Elical 2, Elitech Clinical Systems Elitrol 1 and 2
510(k) Number
FDA Product Code
CGA
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a glucose oxidase reagent (OpenFDA classification) for in vitro diagnostic use. It is designed for the quantitative measurement of glucose concentrations in human serum and plasma samples. The reagents function through enzymatic reactions to produce measurable results, enabling clinical assessment of glucose levels.

The system comprises Glucose Pap Sl reagent strips, Elical 2, Elitrol 1, and Elitrol 2, intended for use on Vital Scientific Selectra/Flexor or ELITech Selectra Pro Series analyzers. Supplied as single-use reagents, they require no sterilization beyond manufacturer packaging. No MRI safety or reusable components are specified. The device holds an FDA 510(k) clearance (K100525) under regulation 862.1345, classified as Class II (CGA product code).

Other devices from Seppim S.A.S.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Elitech Clinical Systems Glucose Pap Sl System used for?

    This system is designed for the quantitative measurement of glucose concentrations in human serum and plasma samples. The enzymatic glucose oxidase reagent strips enable precise clinical assessment of glucose levels, supporting diabetes management and metabolic monitoring.

  • Which analyzers are compatible with the Elitech Glucose Pap Sl System?

    The system is specifically intended for use with Vital Scientific Selectra/Flexor analyzers and the ELITech Selectra Pro Series. Compatibility is confirmed for these platforms only, ensuring accurate and reliable glucose measurements.

  • Are the Elitech Glucose Pap Sl reagents single-use or reusable?

    The reagents—Glucose Pap Sl, Elical 2, Elitrol 1, and Elitrol 2—are supplied as single-use items. This design eliminates the need for sterilization beyond the manufacturer’s sealed packaging, reducing contamination risks and ensuring consistent performance.

  • Do the Elitech Glucose Pap Sl reagents require sterilization beyond packaging?

    No, the reagents are pre-packaged in a sterile state and do not require additional sterilization procedures. The manufacturer’s packaging ensures sterility, making them ready for immediate use on compatible analyzers.

  • What regulatory clearance does the Elitech Glucose Pap Sl System hold?

    The system holds FDA 510(k) clearance under regulation 862.1345, classified as a Class II device (CGA product code). This clearance confirms its substantial equivalence to a predicate device, ensuring compliance with U.S. regulatory standards for in vitro diagnostic use.