Cleared Traditional

K081920 - BD GENEOHM CDIFF ASSAY

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

K081920 · Bd Diagnostics (Geneohm Sciences, Inc.) · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K081920

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.

LLH Device Classification - Class 1, General Controls

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 36
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