Cleared Traditional

K000468 - RANDOX COMPLEMENT C4

K000468 is the FDA 510(k) clearance for RANDOX COMPLEMENT C4 by Randox Laboratories, Ltd.. It is a Class 2 Immunology device (product code DBI) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K000468 · Randox Laboratories, Ltd. · Immunology device
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Mar 2000
Decision
45d
Days
Class 2
Risk

K000468 is an FDA 510(k) clearance for the RANDOX COMPLEMENT C4. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Antrim, N. Ireland, IR). The FDA issued a Cleared decision on March 27, 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 866.5240 - 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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K000468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2000
Decision Date March 27, 2000
Days to Decision 45 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 104d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBI Complement C4, 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 - DBI Complement C4, Antigen, Antiserum, Control

All 23
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K000468.
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
K012359 · Roche Diagnostics Corp. · Nov 2001
WAKO AUTOKIT C4
K010325 · Wako Chemicals USA, Inc. · Jun 2001
DIMENSION C4 FLEX REAGENT CARTRIDGE
K994293 · Dade Behring, Inc. · Mar 2000
C4 MININEPH ANTISERUM
K981785 · The Binding Site, Ltd. · Dec 1999
K-ASSAY C4
K993481 · Kamiya Biomedical Co. · Nov 1999
C4
K983356 · Abbott Laboratories · Nov 1998