Cleared Traditional

K994294 - DIMENSION TRNF FLEX REAGENT CARTRIDGE

K994294 is an FDA 510(k) clearance for DIMENSION TRNF FLEX REAGENT CARTRIDGE, manufactured by Dade Behring, Inc.. The device is a Class 2 Immunology device with product code DDG cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K994294 · Dade Behring, Inc. · Immunology device
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Feb 2000
Decision
45d
Days
Class 2
Risk

K994294 is an FDA 510(k) clearance for the DIMENSION TRNF FLEX REAGENT CARTRIDGE. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Dade Behring, Inc. (P.O. Box 6101, Newark, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - 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

FDA 510(k) Submission Details - K994294

510(k) Number K994294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1999
Decision Date February 04, 2000
Days to Decision 45 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
60d faster than avg
Panel avg: 105d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDG Device Classification - Class 2, Special Controls

Product Code DDG Transferrin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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 - DDG Transferrin, Antigen, Antiserum, Control

All 42
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K994294.
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
K011662 · The Binding Site, Ltd. · Jul 2001
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315
K003064 · Roche Diagnostics Corp. · May 2001
RANDOX TRANSFERRIN
K002585 · Randox Laboratories, Ltd. · Feb 2001
K-ASSAY TRANSFERRIN
K993537 · Kamiya Biomedical Co. · Nov 1999
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
K993162 · Wako Chemicals USA, Inc. · Nov 1999
N LATEX STFR REAGENT
K991157 · Dade Behring, Inc. · Aug 1999