Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)

by Techno-path Manufacturing Ltd.

510(k) K242492

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K242492↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK242492	Date30 Dec 2025Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K242492
FDA Product Code: QCH
Models / Variants: Multichem ID-G (09339892190)
Multichem ID-G (SR102G)
Multichem ID-G (SR102MG)
Multichem ID-GNeg (09339906190)
Multichem ID-GNeg (SR102N)
Multichem ID-GNeg (SR102MN)
FDA applicant: Techno-Path Manufacturing , Ltd.

Device Class: Class II
Regulation: 21 CFR Part 866.3920
Advisory Committee: Microbiology
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The Multichem ID-G series is an assayed quality control material for clinical microbiology assays, designed as liquid quality control derived from human plasma. These materials are intended for monitoring the precision of Roche cobas immunoassay systems, consolidating six analytes for qualitative quality control purposes. The product is categorized under FDA’s regulation number 866.3920 and falls within Class II medical devices.

Supplied as liquid controls, the Multichem ID-G and ID-GNeg variants are intended for use in clinical microbiology laboratories. They are single-use materials, with no indication of MRI compatibility or sterility requirements specified beyond standard laboratory handling. Each variant is uniquely referenced by model number (e.g., 09339892190, SR102G) and is authorized under FDA 510(k) clearance (K242492) for microbiology applications. Storage and handling follow standard clinical laboratory protocols for liquid quality control materials.

From the manufacturer

Multichem ID-G -. Multichem ID-G consolidates six analytes. This is a qualitative quality control optimized for Roche cobas® systems and reagents. INFORMATION FOR USA ONLY: This product is not intended for use in donor screening testing.

Source: technopathclinicaldiagnostics.com

Manufacturer's product page: Multichem hsTnThird Party High Sensitive Troponin QC in a Frozen Liquid Stable FormatView Product