510(k) · Cleared
ClearedMultichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techno-Path Manufacturing, Ltd. · QCH Assayed Quality Control Material For Clinical Microbiology Assays
Cleared on Dec 30, 2025 as substantially equivalent to K190428 (Roche Diagnostics, 2019) after a 496-day review. Its family tree reaches back 3 generations to 1979.
- Decided
- Dec 30, 2025
- Review
- 496 days
- Class
- Class II
- Product code
- QCH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to P780012 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backP780012 HAVABAbbott Laboratories · 1979 · Recalled
- 2 generations backK100903 Anti-HavRoche Professional Diagnostics · 2010
- 1 generation backK190428 Elecsys Anti-HAV IIRoche Diagnostics · 2019
- This deviceK242492 Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem…Techno-Path Manufacturing, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P780012 | HAVAB | Abbott Laboratories | 1979 | 1 |
| −2 | K100903 | Anti-Hav | Roche Professional Diagnostics | 2010 | — |
| −1 | K190428 | Elecsys Anti-HAV II | Roche Diagnostics | 2019 | — |
| 0 (this device) | K242492 | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G… | Techno-Path Manufacturing, Ltd. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QCH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190428 | Elecsys Anti-HAV IISummary page 5…21 CFR 866.3920 Classification: Class II Product Code(s): QCH Predicate Device: PreciControl Anti-HAV II [K190428] Substantial Equivalency: Device & Predicate K190428 K242492 Devic… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 46 years and passes through 4 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K190428.
How does its category compare?
All QCH devicesQCH Assayed Quality Control Material For Clinical Microbiology Assays: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QCH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QCH
Too few QCH 510(k)s in any year since 2007 to give a median.
Recalls per year · QCH
No recall names QCH since 2007.
Adverse event reports per year · QCH
No MAUDE report names QCH since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (148 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242492 · printed Nov 6, 2026
Cite this page
510(k) Report. “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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242492
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026