Cleared Traditional

K191964 - BD Kiestra IdentifA (FDA 510(k) Clearance)

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

K191964 · Becton, Dickinson and Company · Microbiology device
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Nov 2021
Decision
834d
Days
Class 2
Risk

K191964 is an FDA 510(k) clearance for the BD Kiestra IdentifA. Classified as Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry (product code QQV), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (Sparks, US). The FDA issued a Cleared decision on November 3, 2021 after a review of 834 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3378 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

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Submission Details

510(k) Number K191964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2019
Decision Date November 03, 2021
Days to Decision 834 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
732d slower than avg
Panel avg: 102d · This submission: 834d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QQV Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3378
Definition An Automated In Vitro Diagnostic System To Prepare Colonies Of Microorganisms Grown On Solid Culture Media From Human Specimens For Qualitative Identification And Differentiation Using Matrix-assisted Laser Desorption/ionization-time Of Flight Mass Spectrometry (maldi-tof Ms).
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.