Cleared Traditional

K935833 - LCX NEISSERIA GONORRHOEAE ASSAY

K935833 is an FDA 510(k) clearance for LCX NEISSERIA GONORRHOEAE ASSAY, manufactured by Abbott Laboratories. The device is a Class 2 Microbiology device with product code LSL cleared through the Traditional 510(k) pathway after a 881-day FDA review.

K935833 · Abbott Laboratories · Microbiology device
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May 1996
Decision
881d
Days
Class 2
Risk

K935833 is an FDA 510(k) clearance for the LCX NEISSERIA GONORRHOEAE ASSAY. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 6, 1996 after a review of 881 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K935833

510(k) Number K935833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1993
Decision Date May 06, 1996
Days to Decision 881 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
779d slower than avg
Panel avg: 102d · This submission: 881d
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 K935833.
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974503 · Roche Molecular Systems, Inc. · Dec 1999
BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
K984631 · Becton Dickinson Microbiology Systems · Nov 1999
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974342 · Roche Molecular Systems, Inc. · May 1999
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