Cleared Traditional

K864803 - GC-LECT(TM)

K864803 is the FDA 510(k) clearance for GC-LECT(TM) by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Microbiology device (product code JTY) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K864803 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
56d
Days
Class 2
Risk

K864803 is an FDA 510(k) clearance for the GC-LECT(TM). Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 3, 1987 after a review of 56 days - a notably fast clearance cycle.

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: 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K864803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1986
Decision Date February 03, 1987
Days to Decision 56 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 102d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 51
Devices cleared under the same product code (JTY) and FDA review panel - the closest regulatory comparables to K864803.
CASMAN MEDIUM BASE
K881527 · Acumedia Manufacturers, Inc. · Apr 1988
PROTEOSE NO. 3 AGAR
K881552 · Acumedia Manufacturers, Inc. · Apr 1988
MARTIN-LEWIS AGAR W/REDUCED VANCOMYCIN C0226
K871541 · Gibco Laboratories Life Technologies, Inc. · Apr 1987
MODIFIED N.Y.C. FERMENTATION MEDIUM BASE
K864078 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1986
BIOTIS MODIFIED THAYER MARTIN
K860384 · Otisville Biotech, Inc. · Feb 1986
CHOCOLATE MUELLER HINTON AGAR
K851579 · Preferred Micro-Media · May 1985