Cleared Traditional

K853488 - STAPH KIT

K853488 is an FDA 510(k) clearance for STAPH KIT, 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 8-day FDA review.

K853488 · Culture Kits, Inc. · Microbiology device
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Aug 1985
Decision
8d
Days
Class 1
Risk

K853488 is an FDA 510(k) clearance for the STAPH KIT. 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 August 28, 1985 after a review of 8 days - a notably fast clearance 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: 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 Culture Kits, Inc. devices

FDA 510(k) Submission Details - K853488

510(k) Number K853488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1985
Decision Date August 28, 1985
Days to Decision 8 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 102d · This submission: 8d
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 K853488.
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APL SALMONELLA-SHIGELLA AGAR
K853228 · Apl Medical Supplies · Aug 1985