Cleared Traditional

K792284 - CULTURIA EMB/COLUMBIA CNA W/5% SHEEP

K792284 is the FDA 510(k) clearance for CULTURIA EMB/COLUMBIA CNA W/5% SHEEP by Clinical Convenience Products, Inc.. It is a Class 1 Microbiology device (product code JXA) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K792284 · Clinical Convenience Products, Inc. · Microbiology device
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Dec 1979
Decision
36d
Days
Class 1
Risk

K792284 is an FDA 510(k) clearance for the CULTURIA EMB/COLUMBIA CNA W/5% SHEEP. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Clinical Convenience Products, Inc. (Walker, US). The FDA issued a Cleared decision on December 19, 1979 after a review of 36 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 Clinical Convenience Products, Inc. devices

Submission Details

510(k) Number K792284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1979
Decision Date December 19, 1979
Days to Decision 36 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 102d · This submission: 36d
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 K792284.
ORTHO BACTERIURIA DETECTION SYS
K833834 · Ortho Diagnostic Systems, Inc. · Mar 1984
DIPCHEX DIP-SLIDE CULTURE SYS
K830252 · Granite Diagnostics, Inc. · Mar 1983
BAC-T-SCREEN BACTERIURIA DETECTION DEV
K823850 · Marion Laboratories, Inc. · Mar 1983
MS-2 AUTOMATED URINE SCREENING SYSTEM
K781370 · Abbott Laboratories · Sep 1978
VAC-U-PAC KIDNEY CASSETTE
K781536 · E-Z-Em, Inc. · Sep 1978
MICROCULT-ID
K771672 · Miles Laboratories, Inc. · Dec 1977