Cleared Traditional

K991664 - LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01

K991664 is an FDA 510(k) clearance for LDL CHOLESTEROL, manufactured by A.P. Total Care, Inc.. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 97-day FDA review.

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

FDA 510(k) Submission Details - K991664

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 88d · This submission: 97d
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 64
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K991664.
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
HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
K991665 · A.P. Total Care, Inc. · Aug 1999
DIRECT HDL-CHOLESTEROL REAGENT
K990581 · Kamiya Biomedical Co. · Jun 1999
DIRECT HDL
K981224 · Abbott Laboratories · Aug 1998