Cleared Traditional

K990581 - DIRECT HDL-CHOLESTEROL REAGENT

K990581 is the FDA 510(k) clearance for DIRECT HDL-CHOLESTEROL REAGENT by Kamiya Biomedical Co.. It is a Class 1 Chemistry device (product code LBS) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K990581 · Kamiya Biomedical Co. · Chemistry device
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Jun 1999
Decision
115d
Days
Class 1
Risk

K990581 is an FDA 510(k) clearance for the DIRECT HDL-CHOLESTEROL REAGENT. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on June 18, 1999 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 Kamiya Biomedical Co. devices

Submission Details

510(k) Number K990581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1999
Decision Date June 18, 1999
Days to Decision 115 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
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.

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 44
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K990581.
OLYMPUS HDL CHOLESTEROL REAGENT
K014015 · Olympus America, Inc. · Feb 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
K014032 · Olympus America, Inc. · Feb 2002
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · Roche Diagnostics Corp. · Aug 2001
DIRECT HDL
K981224 · Abbott Laboratories · Aug 1998
DIRECT HDL-CHOLESTROL LIQUID
K982341 · Randox Laboratories, Ltd. · Jul 1998
HDL
K981580 · Abbott Laboratories · Jun 1998