Cleared Traditional

K934759 - CULTURIA MACCONKEY-MUG

K934759 is an FDA 510(k) clearance for CULTURIA MACCONKEY-MUG, manufactured by Clinical Convenience Products, Inc.. The device is a Class 1 Microbiology device with 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

FDA 510(k) Submission Details - K934759

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.

JXA Device Classification - Class 1, General Controls

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 13
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K934759.
URISCREEN
K981084 · Diatech Diagnostics,Inc. · Oct 1998
URINE SCREENING DEVICE
K972676 · Combact Diagnostic Systems , Ltd. · Feb 1998
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