Cleared Traditional

K211630 - VITEK 2 AST-Gram Negative Piperacillin ...

K211630 is an FDA 510(k) clearance for VITEK 2 AST-Gram Negative Piperacillin ..., manufactured by bioMerieux, Inc.. The device is a Class 2 Microbiology device with product code LON cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K211630 · bioMerieux, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
95d
Days
Class 2
Risk

K211630 is an FDA 510(k) clearance for the VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL). Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on August 30, 2021 after a review of 95 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 bioMerieux, Inc. devices

FDA 510(k) Submission Details - K211630

510(k) Number K211630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2021
Decision Date August 30, 2021
Days to Decision 95 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
7d faster than avg
Panel avg: 102d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LON Device Classification - Class 2, Special Controls

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 281
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K211630.
VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)
K212849 · Biom?rieux, Inc. · Feb 2022
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
K210287 · bioMerieux, Inc. · Oct 2021
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
K202396 · bioMerieux, Inc. · Sep 2021
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
K201675 · bioMerieux, Inc. · Jul 2021
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
K211136 · bioMerieux, Inc. · Jun 2021
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
K193299 · bioMerieux, Inc. · Sep 2020