Cleared Traditional

K083536 - DENSICHEK PLUS

K083536 is an FDA 510(k) clearance for DENSICHEK PLUS, manufactured by bioMerieux, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K083536

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.

LON Device Classification - Class 2, Special Controls

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 283
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