Cleared Traditional

K981303 - DIRECT LDL

K981303 is an FDA 510(k) clearance for DIRECT LDL, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code MRR cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K981303 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
115d
Days
Class 1
Risk

K981303 is an FDA 510(k) clearance for the DIRECT LDL. Classified as System, Test, Low Density, Lipoprotein (product code MRR), Class I - General Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on August 3, 1998 after a review of 115 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K981303

510(k) Number K981303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1998
Decision Date August 03, 1998
Days to Decision 115 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
27d slower than avg
Panel avg: 88d · This submission: 115d
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 21
Devices cleared under the same product code (MRR) and FDA review panel - the closest regulatory comparables to K981303.
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
RANDOX DIRECT LDL CHOLESTEROL
K982529 · Randox Laboratories, Ltd. · Sep 1998
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
K981978 · Pointe Scientific, Inc., · Jul 1998
EKTACHEM DT LDL CHOLESTEROL KIT
K955904 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996
DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT
K943150 · Genzyme Corp. · Mar 1995