Cleared Traditional

K092704 - ABBOTT REALTIME CT/NG AND ABBOTT MULTI-...

K092704 is an FDA 510(k) clearance for ABBOTT REALTIME CT/NG AND ABBOTT MULTI-..., manufactured by Abbott Molecular, Inc.. The device is a Class 1 Microbiology device with product code LSK cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K092704 · Abbott Molecular, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
267d
Days
Class 1
Risk

K092704 is an FDA 510(k) clearance for the ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODEL.... Classified as Dna-reagents, Chlamydia (product code LSK), Class I - General Controls.

Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on May 28, 2010 after a review of 267 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - 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 Abbott Molecular, Inc. devices

FDA 510(k) Submission Details - K092704

510(k) Number K092704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2009
Decision Date May 28, 2010
Days to Decision 267 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 102d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

LSK Device Classification - Class 1, General Controls

Product Code LSK Dna-reagents, Chlamydia
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LSK Dna-reagents, Chlamydia

Devices cleared under the same product code (LSK) and FDA review panel - the closest regulatory comparables to K092704.
PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY
K920302 · Gen-Probe, Inc. · Apr 1994
PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS
K920378 · Gen-Probe, Inc. · Apr 1992
GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS
K874878 · Gen-Probe, Inc. · Dec 1987
RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS
K871878 · Gen-Probe, Inc. · Oct 1987