Cleared Traditional

K161217 - VITEK 2 Gram Negative Ceftriaxone (<=0....

K161217 is an FDA 510(k) clearance for VITEK 2 Gram Negative Ceftriaxone (<=0...., 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 258-day FDA review.

K161217 · bioMerieux, Inc. · Microbiology device
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Jan 2017
Decision
258d
Days
Class 2
Risk

K161217 is an FDA 510(k) clearance for the VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/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 January 12, 2017 after a review of 258 days - an extended review cycle.

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 - K161217

510(k) Number K161217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2016
Decision Date January 12, 2017
Days to Decision 258 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
156d slower than avg
Panel avg: 102d · This submission: 258d
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 K161217.
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
K161510 · bioMerieux, Inc. · Feb 2017
VITEK 2 AST-GN Tobramycin (/= 16 ug/mL)
K163083 · bioMerieux, Inc. · Feb 2017
VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)
K163006 · bioMerieux, Inc. · Jan 2017
VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
K161227 · bioMerieux, Inc. · Jul 2016
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)
K152075 · bioMerieux, Inc. · Apr 2016
BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
K151320 · Becton, Dickinson and Company · Jan 2016