Cleared Traditional

K014103 - SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL...

K014103 is the FDA 510(k) clearance for SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL... by Beckman Coulter, Inc.. It is a Class 1 Chemistry device (product code MRR) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K014103 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
46d
Days
Class 1
Risk

K014103 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR. Classified as System, Test, Low Density, Lipoprotein (product code MRR), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on January 28, 2002 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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 Beckman Coulter, Inc. devices

Submission Details

510(k) Number K014103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2001
Decision Date January 28, 2002
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
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.

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 K014103.
VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II
K041720 · Ortho-Clinical Diagnostics, Inc. · Aug 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
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
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
K982848 · Roche Diagnostic Systems, Inc. · Oct 1998