Cleared Traditional

K811382 - LAB-TEK JEMBEC G.C. CULTURE SYSTEM

K811382 is the FDA 510(k) clearance for LAB-TEK JEMBEC G.C. CULTURE SYSTEM by Miles Laboratories, Inc.. It is a Class 2 Microbiology device (product code JTY) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K811382 · Miles Laboratories, Inc. · Microbiology device
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Jun 1981
Decision
32d
Days
Class 2
Risk

K811382 is an FDA 510(k) clearance for the LAB-TEK JEMBEC G.C. CULTURE SYSTEM. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981 after a review of 32 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K811382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1981
Decision Date June 16, 1981
Days to Decision 32 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
70d faster than avg
Panel avg: 102d · This submission: 32d
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 46
Devices cleared under the same product code (JTY) and FDA review panel - the closest regulatory comparables to K811382.
MARTIN-LEWIS/PRONG AGAR
K821551 · Gibco Laboratories Life Technologies, Inc. · Jun 1982
GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)
K812078 · Abbott Laboratories · Jul 1981
THAYER-MARTIN, GC AGAR BASE
K811645 · Hardy Media · Jul 1981
GC AGAR
K811053 · Acumedia Manufacturers, Inc. · Apr 1981
MODIFIED THAYER-MARTIN X AGAR
K800333 · Isle Media and Sterile Products, Inc. · Mar 1980
MARTIN-LEWIS AGAR
K800334 · Isle Media and Sterile Products, Inc. · Mar 1980