Cleared Traditional

K870864 - CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K870864 · Marion Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1987
Decision
42d
Days
Class 1
Risk

K870864 is an FDA 510(k) clearance for the CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST. Classified as Reagents, Clostridium Difficile Toxin (product code LLH), Class I - General Controls.

Submitted by Marion Laboratories, Inc. (Kansas City, US). The FDA issued a Cleared decision on April 14, 1987 after a review of 42 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marion Laboratories, Inc. devices

Submission Details

510(k) Number K870864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date April 14, 1987
Days to Decision 42 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 102d · This submission: 42d
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.