Cleared Traditional

K002585 - RANDOX TRANSFERRIN

K002585 is the FDA 510(k) clearance for RANDOX TRANSFERRIN by Randox Laboratories, Ltd.. It is a Class 2 Chemistry device (product code DDG) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K002585 · Randox Laboratories, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
168d
Days
Class 2
Risk

K002585 is an FDA 510(k) clearance for the RANDOX TRANSFERRIN. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on February 5, 2001 after a review of 168 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5880 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K002585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2000
Decision Date February 05, 2001
Days to Decision 168 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 88d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.

Regulatory Peers - DDG Transferrin, Antigen, Antiserum, Control

All 38
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K002585.
TINA-QUANT TRANSFERRIN VER.2
K012393 · Roche Diagnostics Corp. · Sep 2001
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
DIMENSION TRNF FLEX REAGENT CARTRIDGE
K994294 · Dade Behring, Inc. · Feb 2000
K-ASSAY TRANSFERRIN
K993537 · Kamiya Biomedical Co. · Nov 1999
WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
K993162 · Wako Chemicals USA, Inc. · Nov 1999