BD MAX Check-Points CPO

FDA 510(k) K190613 · Check-Points Health B.V.

Substantially Equivalent

510(k) numberK190613

Submission

Device name
BD MAX Check-Points CPO
Applicant
Check-Points Health B.V.
Wageningen, NL
Received
March 11, 2019
Decision date
August 29, 2019
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)DeviceApplicantDecision
K261867Xpert Carba-RPOC · Special Cepheid®07/02/2026SE
K173263Xpert Carba-RPOC · Traditional Cepheid01/09/2018SE
K160901Xpert Carba-RPOC · Traditional Cepheid06/29/2016SE

Questions and answers

When was BD MAX Check-Points CPO cleared by the FDA?

BD MAX Check-Points CPO (K190613) received a 510(k) decision of Substantially Equivalent on August 29, 2019, 171 days after the submission was received.

What is the product code of K190613?

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.