# K242492: Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)

- Pathway: 510(k) (Traditional)
- Applicant: Techno-Path Manufacturing, Ltd.
- Decided: Dec 30, 2025 after 496 days
- Product code: QCH (Assayed Quality Control Material For Clinical Microbiology Assays)
- Device class: 2
- Regulation: 21 CFR 866.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P780012 (1979). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190428: Elecsys Anti-HAV II, Roche Diagnostics (2019) Summary page 5.

## Indications for use
Multichem ID-G: Multichem ID-G is intended for use as a qualitative positive quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer’s recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements. Multichem ID-GNeg: Multichem ID-GNeg is intended for use as a qualitative negative quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer’s recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.

Source page: https://510kreport.com/device/K242492
Methodology: https://510kreport.com/methodology