Cleared Traditional

BD MAX Check-Points CPO (K190613) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190613 · Check-Points Health B.V. · Microbiology device
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Aug 2019
Decision
171d
Days
Class 2
Risk

K190613 is an FDA 510(k) clearance for the BD MAX Check-Points CPO. Classified as System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen (product code POC), Class II - Special Controls.

Submitted by Check-Points Health B.V. (Wageningen, NL). The FDA issued a Cleared decision on August 29, 2019 after a review of 171 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Check-Points Health B.V. devices

Submission Details

510(k) Number K190613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2019
Decision Date August 29, 2019
Days to Decision 171 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
69d slower than avg
Panel avg: 102d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
Definition To Detect The Presence Of Genetic Markers Of Antimicrobial Resistance By Testing Directly From Clinical Specimens Using Nucleic Acid Amplification Technology.
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 - POC System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

Devices cleared under the same product code (POC) and FDA review panel - the closest regulatory comparables to K190613.
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