Cleared Traditional

K082140 - XPERT MRSA/SA BLOOD CULTURE ASSAY

K082140 is the FDA 510(k) clearance for XPERT MRSA/SA BLOOD CULTURE ASSAY by Cepheid. It is a Class 2 Microbiology device (product code NQX) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K082140 · Cepheid · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
61d
Days
Class 2
Risk

K082140 is an FDA 510(k) clearance for the XPERT MRSA/SA BLOOD CULTURE ASSAY. Classified as System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen (product code NQX), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on September 29, 2008 after a review of 61 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 Cepheid devices

Submission Details

510(k) Number K082140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2008
Decision Date September 29, 2008
Days to Decision 61 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
41d faster than avg
Panel avg: 102d · This submission: 61d
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 13
Devices cleared under the same product code (NQX) and FDA review panel - the closest regulatory comparables to K082140.
XPERT MRSA/SA BC (BLOOD CULTURE) ASSAY MODEL GXMRSA/SA-BC-10
K101879 · Cepheid · Jul 2010
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
K091409 · Roche Molecular Systems, Inc. · Jul 2010
XPERT MRSA/SA NASAL ASSAY
K100822 · Cepheid · Jun 2010
XPERT MRSA/SA SSTI ASSAY
K080837 · Cepheid · Sep 2008
XPERT MRSA
K070462 · Cepheid · Apr 2007