Atlas FDA

Xpert® SA Nasal Complete

FDA 510(k) clearance K243070 · decided 2024-10-25

Clearance details

K-number
K243070
Device name
Xpert® SA Nasal Complete
Applicant
Cepheid®
Decision
Substantially Equivalent
Date received
2024-09-27
Decision date
2024-10-25
Days to decision
28 days
Clearance type
Special
Product code
NQX
Device class
2
Regulation number
866.1640
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Sunnyvale, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Xpert MRSA/SA SSTI (K243625)Cepheid®2024-12-18
ARIES MRSA Assay (K191742)Luminex Corporation2019-09-25
Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System (K190771)Cepheid2019-04-25
Xpert MRSA NxG (K162444)Cepheid2016-11-23
cobas MRSA/SA Test (K142721)Roche Molecular Systems, Inc.2014-12-17
BD MAX MRSA XT, BD MAX INSTRUMENT (K133605)Geneohm Sciences Canada, Inc.2013-12-20
BD MAX STAPHSR ASSAY, INSTRUMENT (K132822)Geneohm Sciences Canada, Inc. (Bd Diagnostics)2013-11-26
MRSA/SA ELITE MGB, ELITE MGB SOFTWARE (K132468)Elitechgroup Epoch Biosciences2013-10-17
XPERT MRSA/SA BLOOD CULTURE ASSAY; GENEXPERT DX SYSTEMS (GX-I, GX-II, GX-IV, GX-XVI); GENEXPERT INFINITY-48 SYSTEM; GENE (K130894)Cepheid2013-06-20
BD MAX MRSA ASSAY, BD MAX INSTRUMENT (K120138)Bd Diagnostics (Geneohm Sciences Canada, Inc)2012-07-05
MRSA/SA ELITE MGB (K112937)Elitech2012-06-01
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S) (K112424)Nanosphere, Inc.2011-12-16

Recalls involving this device

RecordFirmDate
Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA N recall (Z-0414-2026)Cepheid2025-10-30