Cleared Traditional

CDTOX A OIA (K991829) - FDA 510(k) Clearance

Class I Microbiology device.

K991829 · Biostar, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
158d
Days
Class 1
Risk

K991829 is an FDA 510(k) clearance for the CDTOX A OIA. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Biostar, Inc. (Boulder, US). The FDA issued a Cleared decision on November 2, 1999 after a review of 158 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 Biostar, Inc. devices

Submission Details

510(k) Number K991829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1999
Decision Date November 02, 1999
Days to Decision 158 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
56d slower than avg
Panel avg: 102d · This submission: 158d
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 41
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K991829.
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VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
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VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K072138 · bioMerieux, Inc. · Dec 2007
COLORPAC TOXIN A
K980185 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
CULTURETTE BRAND TOXIN CD TEST
K925329 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993