Cleared Traditional

K071026 - BD GENEOHM STAPHSR ASSAY

K071026 is an FDA 510(k) clearance for BD GENEOHM STAPHSR ASSAY, manufactured by Bd Diagnostics (Geneohm Sciences Canada, Inc). The device is a Class 2 Microbiology device with product code NQX cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K071026 · Bd Diagnostics (Geneohm Sciences Canada, Inc) · Microbiology device
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Dec 2007
Decision
253d
Days
Class 2
Risk

K071026 is an FDA 510(k) clearance for the BD GENEOHM STAPHSR 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 Canada, Inc) (San Diego, US). The FDA issued a Cleared decision on December 20, 2007 after a review of 253 days - an extended review 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: 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 Bd Diagnostics (Geneohm Sciences Canada, Inc) devices

FDA 510(k) Submission Details - K071026

510(k) Number K071026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2007
Decision Date December 20, 2007
Days to Decision 253 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
151d slower than avg
Panel avg: 102d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQX Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (NQX) and FDA review panel - the closest regulatory comparables to K071026.
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
IDI-MRSA ASSAY
K042357 · Infectio Diagnostic (I.D.I.), Inc. · Oct 2004