Cleared Traditional

K003619 - DRIED GRAM-POSITIVE MIC/COMBO PANELS

K003619 is the FDA 510(k) clearance for DRIED GRAM-POSITIVE MIC/COMBO PANELS by Dade Microscan, Inc.. It is a Class 2 Microbiology device (product code LTT) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K003619 · Dade Microscan, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
48d
Days
Class 2
Risk

K003619 is an FDA 510(k) clearance for the DRIED GRAM-POSITIVE MIC/COMBO PANELS. Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Dade Microscan, Inc. (West Sacramento, US). The FDA issued a Cleared decision on January 9, 2001 after a review of 48 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 Microscan, Inc. devices

Submission Details

510(k) Number K003619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2000
Decision Date January 09, 2001
Days to Decision 48 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
54d faster than avg
Panel avg: 102d · This submission: 48d
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 44
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K003619.
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010159 · Dade Microscan, Inc. · Jul 2001
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
K011116 · Pasco Laboratories, Inc. · Apr 2001
PASCO MIC AND MIC/ID PANELS
K010508 · Pasco Laboratories, Inc. · Apr 2001
PASCO MIC AND MIC/ID PANELS
K001721 · Pasco Laboratories, Inc. · Aug 2000
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K993102 · Dade Microscan, Inc. · Dec 1999
PASCO MIC AND MIC/ID PANELS
K973317 · Pasco Laboratories, Inc. · Nov 1997