Cleared Traditional

K213280 - BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App (FDA 510(k) Clearance)

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

K213280 · Bd Kiestra B.V. · Microbiology device
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May 2023
Decision
580d
Days
Class 2
Risk

K213280 is an FDA 510(k) clearance for the BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, B.... Classified as Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms (product code QQY), Class II - Special Controls.

Submitted by Bd Kiestra B.V. (Drachten, NL). The FDA issued a Cleared decision on May 4, 2023 after a review of 580 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2190 - 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.

View all Bd Kiestra B.V. devices

Submission Details

510(k) Number K213280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2021
Decision Date May 04, 2023
Days to Decision 580 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
478d slower than avg
Panel avg: 102d · This submission: 580d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QQY Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2190
Definition Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms Is An Automated System To Assess The Presence Or Absence Of Colony Growth On Solid Chromogenic Culture Media.
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.