Cleared Traditional

LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01 (K991664) - FDA 510(k) Clearance

Class I Chemistry device.

K991664 · A.P. Total Care, Inc. · Chemistry device
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Aug 1999
Decision
97d
Days
Class 1
Risk

K991664 is an FDA 510(k) clearance for the LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on August 19, 1999 after a review of 97 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 A.P. Total Care, Inc. devices

Submission Details

510(k) Number K991664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1999
Decision Date August 19, 1999
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 88d · This submission: 97d
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 79
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K991664.
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K042195 · Beckman Coulter, Inc. · Sep 2004
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K040767 · Beckman Coulter, Inc. · Jun 2004
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610 · Roche Diagnostics Corp. · Dec 2003