Cleared Traditional

GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST (K872628) - FDA 510(k) Clearance

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

K872628 · Ortho Diagnostic Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1987
Decision
168d
Days
Class 2
Risk

K872628 is an FDA 510(k) clearance for the GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on December 21, 1987 after a review of 168 days - an extended review 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: 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K872628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1987
Decision Date December 21, 1987
Days to Decision 168 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 102d · This submission: 168d
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 K872628.
Aptima Neisseria gonorrhoeae Assay
K231329 · Hologic, Inc. · Jan 2024
Aptima Combo 2 Assay (Panther System)
K180681 · Hologic, Inc. · Jun 2018
cobas CT/NG for use on cobas 6800/8800 systems
K173887 · Roche Molecular Systems, Inc. · Mar 2018
Xpert CT/NG
K173840 · Cepheid · Mar 2018
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K053289 · Roche Diagnostics Corp. · Aug 2006
LCX NEISSERIA GONORRHOEAE ASSAY
K935833 · Abbott Laboratories · May 1996