Cleared Traditional

K872050 - PARAMAX CHOLESTEROL REAGENT

K872050 is the FDA 510(k) clearance for PARAMAX CHOLESTEROL REAGENT by American Dade. It is a Class 1 Chemistry device (product code LBS) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K872050 · American Dade · Chemistry device
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Jul 1987
Decision
40d
Days
Class 1
Risk

K872050 is an FDA 510(k) clearance for the PARAMAX CHOLESTEROL REAGENT. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on July 7, 1987 after a review of 40 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.

View all American Dade devices

Submission Details

510(k) Number K872050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1987
Decision Date July 07, 1987
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
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 47
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K872050.
IQ HDL CHOLESTEROL
K881891 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1988
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683
K874397 · Em Diagnostic Systems, Inc. · Nov 1987
ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL
K871265 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1987
VISION (TM) HDL CHOLESTEROL
K871461 · Abbott Laboratories · May 1987
ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE
K864522 · Beckman Instruments, Inc. · Feb 1987
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
K862845 · Em Diagnostic Systems, Inc. · Aug 1986