Cleared Traditional

K081920 - BD GENEOHM CDIFF ASSAY

K081920 is the FDA 510(k) clearance for BD GENEOHM CDIFF ASSAY by Bd Diagnostics (Geneohm Sciences, Inc.). It is a Class 1 Microbiology device (product code LLH) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K081920 · Bd Diagnostics (Geneohm Sciences, Inc.) · Microbiology device
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Dec 2008
Decision
169d
Days
Class 1
Risk

K081920 is an FDA 510(k) clearance for the BD GENEOHM CDIFF ASSAY. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Bd Diagnostics (Geneohm Sciences, Inc.) (San Diego, US). The FDA issued a Cleared decision on December 19, 2008 after a review of 169 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Diagnostics (Geneohm Sciences, Inc.) devices

Submission Details

510(k) Number K081920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2008
Decision Date December 19, 2008
Days to Decision 169 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 102d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLH Reagents, Clostridium Difficile Toxin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LLH Reagents, Clostridium Difficile Toxin

All 30
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K081920.
SensiTox C. difficile Toxin Test
K193490 · First Light Diagnostics, Inc. · Jul 2021
XPERT C. DIFFICILE
K091109 · Cepheid · Jul 2009
C. DIFF QUIK CHEK COMPLETE
K082499 · Techlab, Inc. · Mar 2009
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
K080931 · bioMerieux, Inc. · Jun 2008
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K072138 · bioMerieux, Inc. · Dec 2007
TOX A/B QUICK CHEK
K050891 · Techlab, Inc. · Jul 2005