Cleared Traditional

K191889 - NG-Test CARBA 5 (FDA 510(k) Clearance)

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

K191889 · Ng Biotech · Microbiology device
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Oct 2019
Decision
79d
Days
Class 2
Risk

K191889 is an FDA 510(k) clearance for the NG-Test CARBA 5. Classified as Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates (product code PTJ), Class II - Special Controls.

Submitted by Ng Biotech (Guipry, FR). The FDA issued a Cleared decision on October 2, 2019 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K191889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2019
Decision Date October 02, 2019
Days to Decision 79 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 102d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PTJ Phenotypic Test Kit, Non-susceptible/elevated Mic Organisms, Cultured Isolates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
Definition Qualitative Detection Of Carbapenemase Enzymes In Pure Colonies Of Enterobacteriaceae And Pseudomonas Aeruginosa That Have Elevated Mic Values To Any Carbapenem
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.