510(k) K112424

VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) by Nanosphere, Inc. — Product Code NQX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 16, 2011
Date Received: August 23, 2011
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen
Device Class: Class II
Regulation Number: 866.1640
Review Panel: MI
Submission Type

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.

Other clearances by Nanosphere, Inc.

K143653 — Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) (September 4, 2015)
K140083 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) (June 20, 2014)
K132843 — VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) (January 8, 2014)
K123197 — VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) (December 5, 2012)
K120466 — VERIGENE CYP2C19 NUCLEIC ACID TES (2C19) (November 6, 2012)
K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (September 19, 2012)
DEN120014 — VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (June 26, 2012)
K103209 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+) (January 10, 2011)
K093337 — VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (November 17, 2009)
K092957 — VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST (October 21, 2009)

Other clearances for product code NQX

K243625 — Xpert MRSA/SA SSTI (December 18, 2024)
K243070 — Xpert® SA Nasal Complete (October 25, 2024)
K191742 — ARIES MRSA Assay (September 25, 2019)
K190771 — Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, (April 25, 2019)
K162444 — Xpert MRSA NxG (November 23, 2016)
K142721 — cobas MRSA/SA Test (December 17, 2014)
K133605 — BD MAX MRSA XT, BD MAX INSTRUMENT (December 20, 2013)
K132822 — BD MAX STAPHSR ASSAY, INSTRUMENT (November 26, 2013)
K132468 — MRSA/SA ELITE MGB, ELITE MGB SOFTWARE (October 17, 2013)
K130894 — XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX- (June 20, 2013)