Cleared Traditional

K771035 - CULTURE TEST FOR NEISSERIA GONORRHOEAE

K771035 is the FDA 510(k) clearance for CULTURE TEST FOR NEISSERIA GONORRHOEAE by Miles Laboratories, Inc.. It is a Class 2 Microbiology device (product code JTY) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K771035 · Miles Laboratories, Inc. · Microbiology device
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Jul 1977
Decision
25d
Days
Class 2
Risk

K771035 is an FDA 510(k) clearance for the CULTURE TEST FOR NEISSERIA GONORRHOEAE. 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 July 5, 1977 after a review of 25 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 K771035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1977
Decision Date July 05, 1977
Days to Decision 25 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
77d faster than avg
Panel avg: 102d · This submission: 25d
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 K771035.
MARTIN LEWIS AGAR (JEMBEC)
K771870 · Granite Diagnostics, Inc. · Oct 1977
MARTIN LEWIS AGAR (PLATE)
K771871 · Granite Diagnostics, Inc. · Oct 1977
MARTIN LEWIS TRANSGROW
K771872 · Granite Diagnostics, Inc. · Oct 1977
IMPROVED THAYER MARTIN (PLATE)
K770874 · Granite Diagnostics, Inc. · Jun 1977
IMPROVED THAYER MARTIN (JEMBEC)
K770875 · Granite Diagnostics, Inc. · Jun 1977
IMPROVED TRANSGROW
K770876 · Granite Diagnostics, Inc. · Jun 1977