Cleared Traditional

CANDI-KIT TM (K854672) - FDA 510(k) Clearance

Class I Microbiology device.

K854672 · Culture Kits, Inc. · Microbiology device
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Jul 1986
Decision
232d
Days
Class 1
Risk

K854672 is an FDA 510(k) clearance for the CANDI-KIT TM. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Culture Kits, Inc. (Norwich, US). The FDA issued a Cleared decision on July 11, 1986 after a review of 232 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Culture Kits, Inc. devices

Submission Details

510(k) Number K854672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1985
Decision Date July 11, 1986
Days to Decision 232 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 102d · This submission: 232d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSI Culture Media, Selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSI Culture Media, Selective And Differential

All 284
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K854672.
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BRILLIANT GREEN AGAR
K871094 · bioMerieux, Inc. · Apr 1987
CANDIDA BROM CRESOL GREEN AGAR
K864077 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1986
CAL (CELLOBIOSE-ARGININE-LYSINE) AGAR
K863519 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS
K863525 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986