Cleared Traditional

K990581 - DIRECT HDL-CHOLESTEROL REAGENT

K990581 is an FDA 510(k) clearance for DIRECT HDL-CHOLESTEROL REAGENT, manufactured by Kamiya Biomedical Co.. The device is a Class 1 Chemistry device with 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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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K990581

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.

LBS Device Classification - Class 1, General Controls

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 69
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K990581.
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · Roche Diagnostics Corp. · Aug 2001
LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01
K991664 · A.P. Total Care, Inc. · Aug 1999
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
K991665 · A.P. Total Care, Inc. · Aug 1999
HDLC PRECIPITATING REAGENT
K982539 · Ac Biochemicals, Inc. · Sep 1998
DIRECT HDL
K981224 · Abbott Laboratories · Aug 1998
DIRECT HDL-CHOLESTROL LIQUID
K982341 · Randox Laboratories, Ltd. · Jul 1998