Cleared Traditional

K994296 - DIMENSION C3 FLEX REAGENT CARTRIDGE

K994296 is the FDA 510(k) clearance for DIMENSION C3 FLEX REAGENT CARTRIDGE by Dade Behring, Inc.. It is a Class 2 Immunology device (product code CZW) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K994296 · Dade Behring, Inc. · Immunology device
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Mar 2000
Decision
71d
Days
Class 2
Risk

K994296 is an FDA 510(k) clearance for the DIMENSION C3 FLEX REAGENT CARTRIDGE. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on March 1, 2000 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - the FDA immunology 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 K994296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1999
Decision Date March 01, 2000
Days to Decision 71 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 104d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 Immunology devices follow this clearance model.

Regulatory Peers - CZW Complement C3, Antigen, Antiserum, Control

All 28
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K994296.
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
K012361 · Roche Diagnostics Corp. · Nov 2001
WAKO AUTOKIT C3
K010326 · Wako Chemicals USA, Inc. · Jun 2001
RANDOX COMPLEMENT C3
K000469 · Randox Laboratories, Ltd. · Mar 2000
C3 MININEPH ANTISERUM
K981783 · The Binding Site, Ltd. · Dec 1999
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991907 · Bayer Corp. · Nov 1999
C3
K983441 · Abbott Laboratories · Nov 1998