Cleared Traditional

K895583 - ACCUPROBE NEISSERIA GONORRHOEAE CULTURE...

K895583 is an FDA 510(k) clearance for ACCUPROBE NEISSERIA GONORRHOEAE CULTURE..., manufactured by Gen-Probe, Inc.. The device is a Class 2 Microbiology device with product code LSL cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K895583 · Gen-Probe, Inc. · Microbiology device
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Nov 1989
Decision
60d
Days
Class 2
Risk

K895583 is an FDA 510(k) clearance for the ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on November 14, 1989 after a review of 60 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 Gen-Probe, Inc. devices

FDA 510(k) Submission Details - K895583

510(k) Number K895583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1989
Decision Date November 14, 1989
Days to Decision 60 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
42d faster than avg
Panel avg: 102d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSL Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K895583.
LCX NEISSERIA GONORRHOEAE ASSAY
K935833 · Abbott Laboratories · May 1996
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
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