Cleared Traditional

K864252 - THAYER-MARTIN JEMBEC

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

K864252 · Mds Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K864252

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
Combination Product No
PCCP Authorized No
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.

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 59
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
THAYER MARTIN AGAR
K864253 · Mds Laboratories, Inc. · Mar 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