Cleared Traditional

K800334 - MARTIN-LEWIS AGAR

K800334 is the FDA 510(k) clearance for MARTIN-LEWIS AGAR by Isle Media and Sterile Products, Inc.. It is a Class 2 Microbiology device (product code JTY) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K800334 · Isle Media and Sterile Products, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1980
Decision
18d
Days
Class 2
Risk

K800334 is an FDA 510(k) clearance for the MARTIN-LEWIS AGAR. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Isle Media and Sterile Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 3, 1980 after a review of 18 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 Isle Media and Sterile Products, Inc. devices

Submission Details

510(k) Number K800334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1980
Decision Date March 03, 1980
Days to Decision 18 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
84d faster than avg
Panel avg: 102d · This submission: 18d
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 K800334.
LAB-TEK JEMBEC G.C. CULTURE SYSTEM
K811382 · Miles Laboratories, Inc. · Jun 1981
GC AGAR
K811053 · Acumedia Manufacturers, Inc. · Apr 1981
MODIFIED THAYER-MARTIN X AGAR
K800333 · Isle Media and Sterile Products, Inc. · Mar 1980
MODIFIED THAYER-MARTIN AGAR (PLATE)
K791425 · American Laboratory Supply, Inc. · Sep 1979
TRANSGROW
K791554 · American Laboratory Supply, Inc. · Sep 1979
MARTIN-LEWIS AGAR (PLATE)
K791557 · American Laboratory Supply, Inc. · Sep 1979