Cleared Traditional

K242492 - Multichem ID-G (09339892190) (FDA 510(k) Clearance)

Also includes:
Multichem ID-G (SR102G) Multichem ID-G (SR102MG) Multichem ID-GNeg (09339906190) Multichem ID-GNeg (SR102N) Multichem ID-GNeg (SR102MN)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242492 · Techno-Path Manufacturing , Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2025
Decision
496d
Days
Class 2
Risk

K242492 is an FDA 510(k) clearance for the Multichem ID-G (09339892190). Classified as Assayed Quality Control Material For Clinical Microbiology Assays (product code QCH), Class II - Special Controls.

Submitted by Techno-Path Manufacturing , Ltd. (Co. Tipperary, IE). The FDA issued a Cleared decision on December 30, 2025 after a review of 496 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3920 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Techno-Path Manufacturing , Ltd. devices

Submission Details

510(k) Number K242492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2024
Decision Date December 30, 2025
Days to Decision 496 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
394d slower than avg
Panel avg: 102d · This submission: 496d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QCH Assayed Quality Control Material For Clinical Microbiology Assays
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3920
Definition Serologic Controls For Microbiology Assays
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.