Cleared Traditional

K854672 - CANDI-KIT TM

K854672 is an FDA 510(k) clearance for CANDI-KIT TM, manufactured by Culture Kits, Inc.. The device is a Class 1 Microbiology device with product code JSI cleared through the Traditional 510(k) pathway after a 232-day FDA review.

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

FDA 510(k) Submission Details - K854672

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.

JSI Device Classification - Class 1, General Controls

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 233
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K854672.
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
BIOTIS TCBS AGAR
K862388 · Otisville Biotech, Inc. · Jul 1986
BIOTIS ACETAMIDE AGAR
K862389 · Otisville Biotech, Inc. · Jul 1986
BIOTIS DESOXYCHOLATE AGAR
K862391 · Otisville Biotech, Inc. · Jul 1986