Cleared Traditional

K093346 - BD GENEOHM MRSA ACP ASSAY

K093346 is the FDA 510(k) clearance for BD GENEOHM MRSA ACP ASSAY by Bd Diagnostics (Geneohm Sciences, Inc.). It is a Class 2 Microbiology device (product code NQX) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K093346 · Bd Diagnostics (Geneohm Sciences, Inc.) · Microbiology device
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Dec 2009
Decision
50d
Days
Class 2
Risk

K093346 is an FDA 510(k) clearance for the BD GENEOHM MRSA ACP ASSAY. Classified as System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (product code NQX), Class II - Special Controls.

Submitted by Bd Diagnostics (Geneohm Sciences, Inc.) (San Diego, US). The FDA issued a Cleared decision on December 15, 2009 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bd Diagnostics (Geneohm Sciences, Inc.) devices

Submission Details

510(k) Number K093346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2009
Decision Date December 15, 2009
Days to Decision 50 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
52d faster than avg
Panel avg: 102d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
Definition A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Mrsa Colonization Status For The Prevention And Control Of Mrsa Infections In Healthcare Settings.
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 - NQX System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

All 14
Devices cleared under the same product code (NQX) and FDA review panel - the closest regulatory comparables to K093346.
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XPERT MRSA/SA NASAL ASSAY
K100822 · Cepheid · Jun 2010
XPERT MRSA/SA BLOOD CULTURE ASSAY
K082140 · Cepheid · Sep 2008
XPERT MRSA/SA SSTI ASSAY
K080837 · Cepheid · Sep 2008
XPERT MRSA
K070462 · Cepheid · Apr 2007