Cleared Traditional

K934759 - CULTURIA MACCONKEY-MUG

K934759 is the FDA 510(k) clearance for CULTURIA MACCONKEY-MUG by Clinical Convenience Products, Inc.. It is a Class 1 Microbiology device (product code JXA) cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K934759 · Clinical Convenience Products, Inc. · Microbiology device
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Sep 1994
Decision
340d
Days
Class 1
Risk

K934759 is an FDA 510(k) clearance for the CULTURIA MACCONKEY-MUG. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Clinical Convenience Products, Inc. (Madison, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Clinical Convenience Products, Inc. devices

Submission Details

510(k) Number K934759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1993
Decision Date September 09, 1994
Days to Decision 340 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
238d slower than avg
Panel avg: 102d · This submission: 340d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXA Kit, Screening, Urine
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 - JXA Kit, Screening, Urine

All 11
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K934759.
BAC-T-SCREEN
K924218 · Biomerieux Vitek, Inc. · Feb 1993
GEN-PROBE PACE SYSTEM URINE SCREEN
K892216 · Gen-Probe, Inc. · Sep 1989
SLIDE CULTURE U 'EIKEN'
K861631 · Syn-Kit, Inc. · Jun 1986
URICHECK
K860905 · Difco Laboratories, Inc. · Apr 1986
BAC-T-SCREEN
K851399 · Marion Laboratories, Inc. · Jun 1985
ORTHO BACTERIURIA DETECTION SYS
K833834 · Ortho Diagnostic Systems, Inc. · Mar 1984