Cleared Traditional

K864252 - THAYER-MARTIN JEMBEC

K864252 is the FDA 510(k) clearance for THAYER-MARTIN JEMBEC by Mds Laboratories, Inc.. It is a Class 2 Microbiology device (product code JTY) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K864252 · Mds Laboratories, Inc. · Microbiology device
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Mar 1987
Decision
154d
Days
Class 2
Risk

K864252 is an FDA 510(k) clearance for the THAYER-MARTIN JEMBEC. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Mds Laboratories, Inc. (L5j 2m4, CA). The FDA issued a Cleared decision on March 31, 1987 after a review of 154 days - an extended review 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: 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 Mds Laboratories, Inc. devices

Submission Details

510(k) Number K864252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date March 31, 1987
Days to Decision 154 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 102d · This submission: 154d
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 47
Devices cleared under the same product code (JTY) and FDA review panel - the closest regulatory comparables to K864252.
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
GC-LECT(TM)
K864803 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 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