Cleared Traditional

K984494 - RANDOX ALBUMIN

K984494 is the FDA 510(k) clearance for RANDOX ALBUMIN by Randox Laboratories, Ltd.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K984494 · Randox Laboratories, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
96d
Days
Class 2
Risk

K984494 is an FDA 510(k) clearance for the RANDOX ALBUMIN. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, GB). The FDA issued a Cleared decision on March 23, 1999 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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 K984494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1998
Decision Date March 23, 1999
Days to Decision 96 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
8d slower than avg
Panel avg: 88d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CIX Bromcresol Green Dye-binding, Albumin

All 76
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K984494.
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER
K011720 · Olympus America, Inc. · Jun 2001
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K992399 · Bayer Corp. · Sep 1999
ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K991576 · Bayer Corp. · Jun 1999
ALBG
K981758 · Abbott Laboratories · Jun 1998
ALBG
K981468 · Abbott Laboratories · May 1998
TRACE COBAS MIRA RANGE
K952488 · Trace Scientific , Ltd. · Oct 1995