Cleared Traditional

K954986 - GC BASE W/ 1% GCHI

K954986 is an FDA 510(k) clearance for GC BASE W/ 1% GCHI, manufactured by Remel, L.P.. The device is a Class 2 Microbiology device with product code JTY cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K954986 · Remel, L.P. · Microbiology device
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Feb 1996
Decision
108d
Days
Class 2
Risk

K954986 is an FDA 510(k) clearance for the GC BASE W/ 1% GCHI. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Remel, L.P. (Lenexa, US). The FDA issued a Cleared decision on February 16, 1996 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2410 - 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 Remel, L.P. devices

FDA 510(k) Submission Details - K954986

510(k) Number K954986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1995
Decision Date February 16, 1996
Days to Decision 108 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 102d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTY Device Classification - Class 2, Special Controls

Product Code JTY Culture Media, For Isolation Of Pathogenic Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2410
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTY Culture Media, For Isolation Of Pathogenic Neisseria

All 53
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