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COBAS-FP Reagents and Calibrators

by Roche Diagnostic Systems, Inc.

510(k) K941712

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK941712 Date13 Jun 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LGJ
Device Class
Class II
Regulation
21 CFR Part 862.3035
Advisory Committee
Clinical Toxicology
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.

The COBAS-FP Reagents and Calibrators are designed for fluorescence polarization immunoassay (FPIA) testing, specifically for measuring gentamicin levels in patient samples. This device falls under the category of Fluorescence Polarization Immunoassay reagents, enabling quantitative analysis of aminoglycoside antibiotics like gentamicin in clinical toxicology applications. It operates by detecting fluorescence polarization changes in a labeled antigen-antibody complex, providing precise concentration measurements of the target analyte.

These reagents and calibrators are intended for use in clinical laboratories equipped with the COBAS-FP analyzer system. Supplied as single-use components, they require no sterilization beyond manufacturer-provided packaging. The product is classified under FDA device class II (862.3035) and holds a 510(k) clearance (K941712) for substantial equivalence in clinical toxicology applications. Storage conditions and expiration dates are specified on the packaging, ensuring proper handling and compliance with regulatory requirements.

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