Cleared Traditional

GONI-KIT (K852582) - FDA 510(k) Clearance

Class I Immunology device.

K852582 · Culture Kits, Inc. · Immunology device
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Jul 1985
Decision
24d
Days
Class 1
Risk

K852582 is an FDA 510(k) clearance for the GONI-KIT. Classified as Kit, Identification, Neisseria Gonorrhoeae (product code JSX), Class I - General Controls.

Submitted by Culture Kits, Inc. (Norwich, US). The FDA issued a Cleared decision on July 12, 1985 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.2660 - the FDA immunology 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

Submission Details

510(k) Number K852582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1985
Decision Date July 12, 1985
Days to Decision 24 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 104d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSX Kit, Identification, Neisseria Gonorrhoeae
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.