Cleared Traditional

K000483 - RANDOX ALBUMIN

K000483 is an FDA 510(k) clearance for RANDOX ALBUMIN, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Chemistry device with product code CJW cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K000483 · Randox Laboratories, Ltd. · Chemistry device
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Mar 2000
Decision
46d
Days
Class 2
Risk

K000483 is an FDA 510(k) clearance for the RANDOX ALBUMIN. Classified as Bromcresol Purple Dye-binding, Albumin (product code CJW), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on March 31, 2000 after a review of 46 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K000483

510(k) Number K000483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2000
Decision Date March 31, 2000
Days to Decision 46 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
42d faster than avg
Panel avg: 88d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJW Device Classification - Class 2, Special Controls

Product Code CJW Bromcresol Purple 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 - CJW Bromcresol Purple Dye-binding, Albumin

All 17
Devices cleared under the same product code (CJW) and FDA review panel - the closest regulatory comparables to K000483.
Albumin BCP
K193001 · SENTINEL CH. SpA · Dec 2019
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
K132664 · Siemens Healthcare Diagnostics, Inc. · Oct 2013
ALBUMIN REAGENT
K021636 · Intersect Systems, Inc. · Jul 2002
ALBUMIN BCG, MODEL AL 103-01
K990978 · A.P. Total Care, Inc. · May 1999
ALBP
K981814 · Abbott Laboratories · Jul 1998
ALBP
K981457 · Abbott Mfg., Inc. · May 1998