Cleared Traditional

K131275 - MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO ...

K131275 is the FDA 510(k) clearance for MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO ... by Siemens Helathcare Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LTT) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K131275 · Siemens Helathcare Diagnostics, Inc. · Microbiology device
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Nov 2013
Decision
189d
Days
Class 2
Risk

K131275 is an FDA 510(k) clearance for the MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS. Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Siemens Helathcare Diagnostics, Inc. (West Sacramento, US). The FDA issued a Cleared decision on November 8, 2013 after a review of 189 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 Siemens Helathcare Diagnostics, Inc. devices

Submission Details

510(k) Number K131275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2013
Decision Date November 08, 2013
Days to Decision 189 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 102d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K131275.
MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
K172255 · Beckman Coulter, Inc. · Dec 2017
MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL)
K162740 · Beckman Coulter, Inc. · Mar 2017
MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL)
K150039 · Siemens Healthcare Diagnostics, Inc. · Jul 2015
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
K123933 · Siemens Healthcare Diagnostics, Inc. · Mar 2013
MICROSCAN MICROSTEP
K111394 · Siemens Healthcare Diagnostics, Inc. · Jun 2011
MICROSCAN MICROSTREP PLUS, MODEL B1027-201
K091949 · Siemens Healthcare Diagnostics · Jan 2010