Cleared Traditional

K982271 - WAKO DIRECT LDL-C

K982271 is an FDA 510(k) clearance for WAKO DIRECT LDL-C, manufactured by Wako Chemicals USA, Inc.. The device is a Class 1 Chemistry device with product code MRR cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K982271 · Wako Chemicals USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
85d
Days
Class 1
Risk

K982271 is an FDA 510(k) clearance for the WAKO DIRECT LDL-C. Classified as System, Test, Low Density, Lipoprotein (product code MRR), Class I - General Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 85 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 Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K982271

510(k) Number K982271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1998
Decision Date September 22, 1998
Days to Decision 85 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
3d faster than avg
Panel avg: 88d · This submission: 85d
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 K982271.
ACE LDL-C REAGENT, LDL-C CALIBRATOR, LDL-C CONTROLS
K991733 · Schiapparelli Biosystems, Inc. · Jul 1999
RDI DIRECT LDL CHOLESTEROL TEST
K984107 · Reference Diagnostics, Inc. · Jan 1999
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
K982848 · Roche Diagnostic Systems, Inc. · Oct 1998
RANDOX DIRECT LDL CHOLESTEROL
K982529 · Randox Laboratories, Ltd. · Sep 1998
DIRECT LDL
K981303 · Abbott Laboratories · Aug 1998
AUTOLDL CHOLESTEROL REAGENT SET AND AUTOLDL CHOLESTEROL CALIBRATOR
K981978 · Pointe Scientific, Inc., · Jul 1998