Cleared Traditional

K833447 - CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-

K833447 is an FDA 510(k) clearance for CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-, manufactured by Bartels Immunodiagnostic Supplies, Inc.. The device is a Class 1 Microbiology device with product code MCB cleared through the Traditional 510(k) pathway after a 229-day FDA review.

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

FDA 510(k) Submission Details - K833447

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 102d · This submission: 229d
Pathway characteristics
Predicate-based equivalence.

MCB Device Classification - Class 1, General Controls

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.