Cleared Traditional

K020575 - ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS

K020575 is an FDA 510(k) clearance for ATAC DIRECT LDL REAGENT AND ATAC DIRECT..., manufactured by Elan Diagnostics. The device is a Class 1 Chemistry device with product code MRR cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K020575 · Elan Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
50d
Days
Class 1
Risk

K020575 is an FDA 510(k) clearance for the ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS. Classified as System, Test, Low Density, Lipoprotein (product code MRR), Class I - General Controls.

Submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on April 12, 2002 after a review of 50 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 Elan Diagnostics devices

FDA 510(k) Submission Details - K020575

510(k) Number K020575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2002
Decision Date April 12, 2002
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

MRR Device Classification - Class 1, General Controls

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 27
Devices cleared under the same product code (MRR) and FDA review panel - the closest regulatory comparables to K020575.
PTS PANELS LDL CHOLESTEROL TEST STRIPS
K040693 · Polymer Technology Systems, Inc. · Jul 2004
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
K022772 · Hemagen Diagnostics, Inc. · Sep 2002
DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
K020724 · Dade Behring, Inc. · May 2002
SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR
K014103 · Beckman Coulter, Inc. · Jan 2002
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K012287 · Roche Diagnostics Corp. · Aug 2001
EZ LDL CHOLESTEROL TEST SYSTEM
K993741 · Sigma Diagnostics, Inc. · Jul 2000