Cleared Traditional

K982848 - COBAS INTEGRA LDL DIRECT REAGENT CASSET...

K982848 is the FDA 510(k) clearance for COBAS INTEGRA LDL DIRECT REAGENT CASSET... by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code MRR) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K982848 · Roche Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
50d
Days
Class 1
Risk

K982848 is an FDA 510(k) clearance for the COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT. Classified as System, Test, Low Density, Lipoprotein (product code MRR), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on October 1, 1998 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K982848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1998
Decision Date October 01, 1998
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.

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 K982848.
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
WAKO DIRECT LDL-C
K982271 · Wako Chemicals USA, Inc. · Sep 1998
RANDOX DIRECT LDL CHOLESTEROL
K982529 · Randox Laboratories, Ltd. · Sep 1998
DIRECT LDL
K981303 · Abbott Laboratories · Aug 1998