Cleared Traditional

K083536 - DENSICHEK PLUS

K083536 is the FDA 510(k) clearance for DENSICHEK PLUS by bioMerieux, Inc.. It is a Class 2 Microbiology device (product code LON) cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K083536 · bioMerieux, Inc. · Microbiology device
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Sep 2009
Decision
287d
Days
Class 2
Risk

K083536 is an FDA 510(k) clearance for the DENSICHEK PLUS. Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on September 11, 2009 after a review of 287 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1645 - 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K083536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2008
Decision Date September 11, 2009
Days to Decision 287 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
185d slower than avg
Panel avg: 102d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1645
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 - LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

All 281
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K083536.
VITEK 2 GRAM POSITIVE DOXCYCLINE
K093076 · bioMerieux, Inc. · Oct 2010
DENSICHECK PLUS
K093224 · bioMerieux, Inc. · Nov 2009
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
K092919 · Siemens Healthcare Diagnostics · Oct 2009
VITEK 2 GRAM NEGATIVE MEROPENEM
K091899 · bioMerieux, Inc. · Aug 2009
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K091126 · bioMerieux, Inc. · Jun 2009
VITEK 2 GRAM NEGATIVE DORIPENEM
K082346 · bioMerieux, Inc. · Mar 2009