Cleared Traditional

K905284 - HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173

K905284 is an FDA 510(k) clearance for HDL-CHOLESTEROL PRECIPITANT 7773/7573/7..., manufactured by Amresco, Inc.. The device is a Class 1 Chemistry device with product code LBR cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K905284 · Amresco, Inc. · Chemistry device
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Dec 1990
Decision
18d
Days
Class 1
Risk

K905284 is an FDA 510(k) clearance for the HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on December 11, 1990 after a review of 18 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K905284

510(k) Number K905284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1990
Decision Date December 11, 1990
Days to Decision 18 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 89d · This submission: 18d
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 65
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K905284.
MAGNETIC HDL CHOLESTEROL TEST
K911906 · Reference Diagnostics, Inc. · Jul 1991
HDL CHOLESTEROL REAGENT
K911406 · Genzyme Corp. · May 1991
ICA PLASMA HDL AND LDL MEASUREMENT SYSTEM
K903733 · Institute For Clinical Applications · Jan 1991
BIOTROL HDL CHOLESTEROL PRECIPITATION REAGENT
K904184 · Biotron U.S.A., Inc. · Nov 1990
STAT TEST HDL/CHOLESTEROL TEST KIT
K903094 · Diagnostic Resources, Inc. · Aug 1990
REFLOTRON HDL CHOLESTEROL TEST TABS
K902568 · Boehringer Mannheim Corp. · Aug 1990
K905284 · HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
Download PDF Amresco, Inc.