Xpert Carba-R

Q: When was Xpert Carba-R cleared by the FDA?

Xpert Carba-R (K160901) received a 510(k) decision of Substantially Equivalent on June 29, 2016, 89 days after the submission was received.

Q: What is the product code of K160901?

The FDA product code is POC – System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen, a Class II (moderate risk) device regulated under 21 CFR 866.1640.

FDA 510(k) K160901 · Cepheid

Substantially Equivalent

510(k) numberK160901

Submission

Device name: Xpert Carba-R
Applicant: Cepheid
Sunnyvale, CA, US
Received: April 1, 2016
Decision date: June 29, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: POC – System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.1640
Specialty: Microbiology

To detect the presence of genetic markers of antimicrobial resistance by testing directly from clinical specimens using nucleic acid amplification technology.

Other 510(k)s with product code POC

510(k)	Device	Applicant	Decision
K261867	Xpert Carba-RPOC · Special	Cepheid®	07/02/2026SE
K190613	BD MAX Check-Points CPOPOC · Traditional	Check-Points Health B.V.	08/29/2019SE
K173263	Xpert Carba-RPOC · Traditional	Cepheid	01/09/2018SE

More from Cepheid

510(k)	Device	Decision
K261362	Xpert Hemorrhagic FeverQVR · Dual Track	08/07/2026SE
K261867	Xpert Carba-RPOC · Special	07/02/2026SE
K253653	Xpert Hemorrhagic Fever · Traditional	02/20/2026SE
K251721	Xpert GI PanelPCH · Traditional	01/16/2026SE
K250996	Xpert Xpress CoV-2/Flu/RSV plusQOF · Special	05/01/2025SE
K250995	Xpert Xpress CoV-2/Flu/RSV plusQOF · Special	05/01/2025SE
K243730	Xpert C. difficile/EpiOZN · Traditional	02/28/2025SE
K250218	Xpert® FII & FVNPR · Special	02/21/2025SE
K242109	Xpert® Xpress CoV-2 plus (XPRS-COV2-10)QQX · Dual Track	01/15/2025SE
K242071	Xpert Xpress CoV-2/Flu/RSV plusQOF · Dual Track	01/10/2025SE

Questions and answers

When was Xpert Carba-R cleared by the FDA?

Xpert Carba-R (K160901) received a 510(k) decision of Substantially Equivalent on June 29, 2016, 89 days after the submission was received.

What is the product code of K160901?

The FDA product code is POC – System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen, a Class II (moderate risk) device regulated under 21 CFR 866.1640.