Cleared Traditional

K243499 - NG-Test® CTX-M MULTI (FDA 510(k) Clearance)

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

K243499 · Ng Biotech · Microbiology device
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Jun 2025
Decision
204d
Days
Class 2
Risk

K243499 is an FDA 510(k) clearance for the NG-Test® CTX-M MULTI. 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 June 4, 2025 after a review of 204 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 Ng Biotech devices

Submission Details

510(k) Number K243499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2024
Decision Date June 04, 2025
Days to Decision 204 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
102d slower than avg
Panel avg: 102d · This submission: 204d
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.

Regulatory Consultant

Hardy Diagnostics
Anna Klavins

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.