Cleared Traditional

K982529 - RANDOX DIRECT LDL CHOLESTEROL

K982529 is the FDA 510(k) clearance for RANDOX DIRECT LDL CHOLESTEROL by Randox Laboratories, Ltd.. It is a Class 1 Chemistry device (product code MRR) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K982529 · Randox Laboratories, Ltd. · Chemistry device
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Sep 1998
Decision
53d
Days
Class 1
Risk

K982529 is an FDA 510(k) clearance for the RANDOX DIRECT LDL CHOLESTEROL. Classified as System, Test, Low Density, Lipoprotein (product code MRR), Class I - General Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, GB). The FDA issued a Cleared decision on September 11, 1998 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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

Submission Details

510(k) Number K982529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1998
Decision Date September 11, 1998
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MRR System, Test, Low Density, Lipoprotein
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MRR System, Test, Low Density, Lipoprotein

All 15
Devices cleared under the same product code (MRR) and FDA review panel - the closest regulatory comparables to K982529.
EZ LDL CHOLESTEROL TEST SYSTEM
K993741 · Sigma Diagnostics, Inc. · Jul 2000
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
K982848 · Roche Diagnostic Systems, Inc. · Oct 1998
WAKO DIRECT LDL-C
K982271 · Wako Chemicals USA, Inc. · Sep 1998
DIRECT LDL
K981303 · Abbott Laboratories · Aug 1998
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
K981978 · Pointe Scientific, Inc., · Jul 1998