Cleared Traditional

K833447 - CYTOTOXICITY ASSAY FOR CLOSTRIDIUM- (FDA 510(k) Clearance)

Class I Microbiology device.

K833447 · Bartels Immunodiagnostic Supplies, Inc. · Microbiology device
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May 1984
Decision
229d
Days
Class 1
Risk

K833447 is an FDA 510(k) clearance for the CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-. Classified as Antigen, C. Difficile (product code MCB), Class I - General Controls.

Submitted by Bartels Immunodiagnostic Supplies, Inc. (Walker, US). The FDA issued a Cleared decision on May 21, 1984 after a review of 229 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 Bartels Immunodiagnostic Supplies, Inc. devices

Submission Details

510(k) Number K833447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1983
Decision Date May 21, 1984
Days to Decision 229 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 102d · This submission: 229d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MCB Antigen, C. Difficile
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.