Cleared Traditional

K883486 - GONOSTAT

K883486 is the FDA 510(k) clearance for GONOSTAT by Technology Management & Marketing, Inc.. It is a Class 2 Microbiology device (product code LSL) cleared through the Traditional 510(k) pathway after a 364-day FDA review.

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 37
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K883486.
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR
K940979 · Gen-Probe, Inc. · Oct 1994
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY
K920301 · Gen-Probe, Inc. · Apr 1994
ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.
K895583 · Gen-Probe, Inc. · Nov 1989
PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS
K881277 · Gen-Probe, Inc. · Apr 1988
GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE
K874620 · Gen-Probe, Inc. · Mar 1988
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST
K872628 · Ortho Diagnostic Systems, Inc. · Dec 1987