Cleared Traditional

Colibrí (K232756) - FDA 510(k) Clearance

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

K232756 · Copan Wasp Srl · Microbiology device
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Dec 2023
Decision
110d
Days
Class 2
Risk

K232756 is an FDA 510(k) clearance for the Colibrí. Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by Copan Wasp Srl (Brescia, IT). The FDA issued a Cleared decision on December 27, 2023 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1645 - 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 Copan Wasp Srl devices

Submission Details

510(k) Number K232756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2023
Decision Date December 27, 2023
Days to Decision 110 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
8d slower than avg
Panel avg: 102d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1645
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 - LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

All 278
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K232756.
BD Phoenix™ Automated Microbiology System
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BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL)
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VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
K234000 · bioMerieux, Inc. · Mar 2024
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
K232201 · bioMerieux, Inc. · Oct 2023
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin
K230864 · bioMerieux, Inc. · Jul 2023
VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)
K222378 · bioMerieux, Inc. · Jun 2023