Cleared Traditional

K903733 - ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM

K903733 is an FDA 510(k) clearance for ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM, manufactured by Institute For Clinical Applications. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K903733 · Institute For Clinical Applications · Chemistry device
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Jan 1991
Decision
152d
Days
Class 1
Risk

K903733 is an FDA 510(k) clearance for the ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Institute For Clinical Applications (Boston, US). The FDA issued a Cleared decision on January 15, 1991 after a review of 152 days - an extended review cycle.

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 Institute For Clinical Applications devices

FDA 510(k) Submission Details - K903733

510(k) Number K903733 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1990
Decision Date January 15, 1991
Days to Decision 152 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 88d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

LBR Device Classification - Class 1, General Controls

Product Code LBR Ldl & Vldl Precipitation, 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 - LBR Ldl & Vldl Precipitation, Hdl

All 55
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K903733.
HIGH DENSITY LIPOPROTEIN CHOLESTEROL
K912823 · Creative Laboratory Products, Inc. · Aug 1991
MAGNETIC HDL CHOLESTEROL TEST
K911906 · Reference Diagnostics, Inc. · Jul 1991
HDL CHOLESTEROL REAGENT
K911406 · Genzyme Corp. · May 1991
HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
K905284 · Amresco, Inc. · Dec 1990
REFLOTRON HDL CHOLESTEROL TEST TABS
K902568 · Boehringer Mannheim Corp. · Aug 1990
COULTER HDL - CHOLESTEROL REAGENT
K902174 · Coulter Corp. · Jul 1990