Cleared Traditional

K895915 - MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM (FDA 510(k) Clearance)

Class I Microbiology device.

K895915 · Meridian Diagnostics, Inc. · Microbiology device
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Mar 1990
Decision
153d
Days
Class 1
Risk

K895915 is an FDA 510(k) clearance for the MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM. Classified as Antigen, C. Difficile (product code MCB), Class I - General Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on March 12, 1990 after a review of 153 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 Meridian Diagnostics, Inc. devices

Submission Details

510(k) Number K895915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1989
Decision Date March 12, 1990
Days to Decision 153 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 102d · This submission: 153d
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.