Techno-Path Manufacturing , Ltd. · Class II · Cleared Dec 30, 2025
| K-number | K242492 |
| Device name | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) |
| Applicant | Techno-Path Manufacturing , Ltd. |
| Product code | QCH |
| Device class | Class II |
| Decision date | Dec 30, 2025 |
| Decision | Substantially Equivalent |
| Regulation | — |
Multichem ID-G and Multichem ID-GNeg are quality control serum materials used to monitor the accuracy and precision of laboratory testing procedures for five infectious disease markers (Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG, and Anti-HIV 1 IgG) on Roche cobas heterogeneous immunoassay systems. The positive control (ID-G) contains these analytes at specified levels, while the negative control (ID-GNeg) does not contain them.
Both controls are supplied as liquid human serum-based materials in single-level formulations (1 or 4 vials of 4 mL each), stored at 2-8°C with an 11-month shelf life and 30-day open vial stability. The positive control is manufactured by spiking a delipidated human serum base with disease-state plasma tested positive for each required analyte using FDA-cleared assays, targeting specific cutoff index (COI) ranges for Roche immunoassays.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov