Cleared Traditional

K250036 - MicroScan Dried Gram-Positive MIC/Combo...

K250036 is an FDA 510(k) clearance for MicroScan Dried Gram-Positive MIC/Combo..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Microbiology device with product code LTT cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K250036 · Beckman Coulter, Inc. · Microbiology device
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Aug 2025
Decision
219d
Days
Class 2
Risk

K250036 is an FDA 510(k) clearance for the MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32.... Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (West Sacramento, US). The FDA issued a Cleared decision on August 15, 2025 after a review of 219 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K250036

510(k) Number K250036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2025
Decision Date August 15, 2025
Days to Decision 219 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 102d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

LTT Device Classification - Class 2, Special Controls

Product Code LTT Panels, Test, Susceptibility, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 - LTT Panels, Test, Susceptibility, Antimicrobial

All 45
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K250036.
MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)
K243804 · Beckman Coulter, Inc. · Aug 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)
K250084 · Beckman Coulter, Inc. · Jul 2025
MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )
K202343 · Beckman Coulter, Inc. · Nov 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
K201423 · Beckman Coulter, Inc. · Jun 2020
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)
K193536 · Beckman Coulter, Inc. · Mar 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)
K193358 · Beckman Coulter, Inc. · Mar 2020