Cleared Traditional

VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) (K211630) - FDA 510(k) Clearance

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

K211630 · bioMerieux, Inc. · Microbiology device
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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

Submission Details

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.

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 K211630.
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K202396 · bioMerieux, Inc. · Sep 2021
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K201675 · bioMerieux, Inc. · Jul 2021
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K211136 · bioMerieux, Inc. · Jun 2021
VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
K193299 · bioMerieux, Inc. · Sep 2020