Cleared Traditional

K980185 - COLORPAC TOXIN A

K980185 is an FDA 510(k) clearance for COLORPAC TOXIN A, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Microbiology device with product code LLH cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K980185 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
178d
Days
Class 1
Risk

K980185 is an FDA 510(k) clearance for the COLORPAC TOXIN A. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on July 17, 1998 after a review of 178 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 Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K980185

510(k) Number K980185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1998
Decision Date July 17, 1998
Days to Decision 178 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
76d slower than avg
Panel avg: 102d · This submission: 178d
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 37
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K980185.
PREMIER TOXINS A&B, MODEL 616096
K993914 · Meridian Diagnostics, Inc. · Dec 1999
CDTOX A OIA
K991829 · Biostar, Inc. · Nov 1999
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
K990664 · Intracel Corp. · Mar 1999
TOX A/B TEST
K971182 · Techlab, Inc. · Jul 1997
VIDAS C. DIFFICILE TOXIN A II ASSAY
K964887 · Biomerieux Vitek, Inc. · Apr 1997
PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY
K964864 · Alexon Biomedical, Inc. · Feb 1997