Cleared Traditional

NEISSERIA GONORRHOEAE FLUORO-KIT (K800328) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K800328 · Clinical Sciences, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1980
Decision
20d
Days
Class 2
Risk

K800328 is an FDA 510(k) clearance for the NEISSERIA GONORRHOEAE FLUORO-KIT. Classified as Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae (product code GTH), Class II - Special Controls.

Submitted by Clinical Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 3, 1980 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - 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 Clinical Sciences, Inc. devices

Submission Details

510(k) Number K800328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1980
Decision Date March 03, 1980
Days to Decision 20 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 102d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GTH Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
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.