Cleared Traditional

K991829 - CDTOX A OIA

K991829 is an FDA 510(k) clearance for CDTOX A OIA, manufactured by Biostar, Inc.. The device is a Class 1 Microbiology device with product code LLH cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K991829 · Biostar, Inc. · Microbiology device
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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

FDA 510(k) Submission Details - K991829

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 102d · This submission: 158d
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 35
Devices cleared under the same product code (LLH) and FDA review panel - the closest regulatory comparables to K991829.
C. DIFFICILE TOX A/B II
K030404 · Techlab, Inc. · Apr 2003
C. DIFFICILE TOX A/B II
K003306 · Techlab, Inc. · Nov 2000
PREMIER TOXINS A&B, MODEL 616096
K993914 · Meridian Diagnostics, Inc. · Dec 1999
PRIMA SYSTEM - OLD, BARTELS ELISA - NEW
K990664 · Intracel Corp. · Mar 1999
COLORPAC TOXIN A
K980185 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
TOX A/B TEST
K971182 · Techlab, Inc. · Jul 1997