Cleared Traditional

K991268 - GONOSTAT GONOCOCCAL DETECTION KIT

K991268 is an FDA 510(k) clearance for GONOSTAT GONOCOCCAL DETECTION KIT, manufactured by Sierra Diagnostics. The device is a Class 2 Microbiology device with product code LSL cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K991268 · Sierra Diagnostics · Microbiology device
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Aug 1999
Decision
120d
Days
Class 2
Risk

K991268 is an FDA 510(k) clearance for the GONOSTAT GONOCOCCAL DETECTION KIT. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Sierra Diagnostics (Washington, US). The FDA issued a Cleared decision on August 11, 1999 after a review of 120 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Sierra Diagnostics devices

FDA 510(k) Submission Details - K991268

510(k) Number K991268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1999
Decision Date August 11, 1999
Days to Decision 120 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
18d slower than avg
Panel avg: 102d · This submission: 120d
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 41
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K991268.
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K974503 · Roche Molecular Systems, Inc. · Dec 1999
HYBRID CAPTURE II GC-ID
K981485 · Digene Corp. · Nov 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
LCX NEISSERIA GONORRHOEAE ASSAY
K935833 · Abbott Laboratories · May 1996
GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR
K940979 · Gen-Probe, Inc. · Oct 1994