Cleared Traditional

GONOSTAT (K883486) - FDA 510(k) Clearance

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

K883486 · Technology Management & Marketing, Inc. · Microbiology device
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Aug 1989
Decision
364d
Days
Class 2
Risk

K883486 is an FDA 510(k) clearance for the GONOSTAT. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Technology Management & Marketing, Inc. (Chicago, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Technology Management & Marketing, Inc. devices

Submission Details

510(k) Number K883486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1988
Decision Date August 15, 1989
Days to Decision 364 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
262d slower than avg
Panel avg: 102d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LSL Dna-reagents, Neisseria
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.

Regulatory Peers - LSL Dna-reagents, Neisseria

All 44
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K883486.
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