Cleared Traditional

K001032 - RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY

K001032 is the FDA 510(k) clearance for RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY by Otsuka Pharmaceutical Co., Ltd.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K001032 · Otsuka Pharmaceutical Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
116d
Days
Class 1
Risk

K001032 is an FDA 510(k) clearance for the RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Otsuka Pharmaceutical Co., Ltd. (Rockville, US). The FDA issued a Cleared decision on July 24, 2000 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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 Otsuka Pharmaceutical Co., Ltd. devices

Submission Details

510(k) Number K001032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2000
Decision Date July 24, 2000
Days to Decision 116 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 88d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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 - CHH Enzymatic Esterase--oxidase, Cholesterol

All 122
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K001032.
EASYRA CHOLESTEROL REAGENT
K072249 · Medica Corp. · Feb 2008
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
K051376 · Roche Diagnostics · Aug 2005
COBAS INTEGRA CHOLESTEROL GEN. 2
K031824 · Roche Diagnostics Corp. · Jul 2003
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
K992803 · Sigma Diagnostics, Inc. · Sep 1999
CHOL
K981652 · Abbott Laboratories · Jun 1998
CHOL
K981476 · Abbott Laboratories · Jun 1998