Cleared Traditional

WAKO HDL CHOLESTEROL TEST (K801834) - FDA 510(k) Clearance

Class I Chemistry device.

K801834 · Wako Pure Chemical Industries, Ltd. · Chemistry device
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Sep 1980
Decision
46d
Days
Class 1
Risk

K801834 is an FDA 510(k) clearance for the WAKO HDL CHOLESTEROL TEST. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Wako Pure Chemical Industries, Ltd. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 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 Wako Pure Chemical Industries, Ltd. devices

Submission Details

510(k) Number K801834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1980
Decision Date September 16, 1980
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
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 LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
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 - LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

All 23
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K801834.
VISION (TM) HDL CHOLESTEROL
K871461 · Abbott Laboratories · May 1987
ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE
K864522 · Beckman Instruments, Inc. · Feb 1987
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
K862845 · Em Diagnostic Systems, Inc. · Aug 1986
TECHNICON HDL CHOLESTEROL METHOD
K791990 · Technicon Instruments Corp. · Oct 1979
CHOLESTEROL KIT, HDL-DS
K790553 · Beckman Instruments, Inc. · Jun 1979