Cleared Traditional

K003341 - EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS

K003341 is an FDA 510(k) clearance for EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TO..., manufactured by Syva Co., Dade Behring, Inc.. The device is a Class 2 Chemistry device with product code KLB cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K003341 · Syva Co., Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
89d
Days
Class 2
Risk

K003341 is an FDA 510(k) clearance for the EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS. Classified as Radioimmunoassay, Tobramycin (product code KLB), Class II - Special Controls.

Submitted by Syva Co., Dade Behring, Inc. (San Jose, US). The FDA issued a Cleared decision on January 22, 2001 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3900 - the FDA in vitro diagnostics and chemistry 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 Syva Co., Dade Behring, Inc. devices

FDA 510(k) Submission Details - K003341

510(k) Number K003341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2000
Decision Date January 22, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 88d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLB Device Classification - Class 2, Special Controls

Product Code KLB Radioimmunoassay, Tobramycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3900
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 Chemistry devices follow this clearance model.

Regulatory Peers - KLB Radioimmunoassay, Tobramycin

All 18
Devices cleared under the same product code (KLB) and FDA review panel - the closest regulatory comparables to K003341.
ONLINE TDM TOBRAMYCIN
K060853 · Roche Diagnostics Corp. · Jun 2006
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
K012312 · Diagnostic Products Corp. · Aug 2001
DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD
K904304 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990
IL TOBRAMYCIN ASSAY
K903192 · Instrumentation Laboratory CO · Aug 1990
TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD
K893913 · Technicon Instruments Corp. · Aug 1989
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY
K882294 · Syva Co. · Jul 1988