Cleared Traditional

K062777 - MICROSCAN MICROSTREP PLUS PANEL

K062777 is the FDA 510(k) clearance for MICROSCAN MICROSTREP PLUS PANEL by Dade Behring, Inc.. It is a Class 2 Microbiology device (product code LTT) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K062777 · Dade Behring, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
22d
Days
Class 2
Risk

K062777 is an FDA 510(k) clearance for the MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN. Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Dade Behring, Inc. (West Sacramento, US). The FDA issued a Cleared decision on October 10, 2006 after a review of 22 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K062777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2006
Decision Date October 10, 2006
Days to Decision 22 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
80d faster than avg
Panel avg: 102d · This submission: 22d
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 34
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K062777.
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
K091264 · Siemens Healthcare Diagnostics · Jul 2009
MICROSCAN DRIED GRAM -NEGATIVE MIC/COMBO PANELS WITH TIGECYCLINE (0.015- 32 MCG/ML)
K083262 · Siemens Healthcare Diagnostics · Feb 2009
MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN
K062773 · Dade Behring, Inc. · Oct 2006
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)
K033940 · Dade Behring, Inc. · Feb 2004
PASCO MIC AND MIC/ID PANELS
K030620 · Pasco Laboratories, Inc. · Apr 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K024357 · Trek Diagnostic Systems, Inc. · Mar 2003