Cleared Traditional

K812574 - HDL CHOLESTEROL REAGENT

K812574 is the FDA 510(k) clearance for HDL CHOLESTEROL REAGENT by Pointe Scientific, Inc.,. It is a Class 1 Chemistry device (product code LBR) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K812574 · Pointe Scientific, Inc., · Chemistry device
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Sep 1981
Decision
15d
Days
Class 1
Risk

K812574 is an FDA 510(k) clearance for the HDL CHOLESTEROL REAGENT. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Pointe Scientific, Inc., (Mchenry, US). The FDA issued a Cleared decision on September 24, 1981 after a review of 15 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K812574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1981
Decision Date September 24, 1981
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 33
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K812574.
HDL CHOLESTEROL PRETREATMENT
K852350 · American Monitor Corp. · Jul 1985
HDL CHOLESTEROL PRETREATMENT
K834251 · American Monitor Corp. · Feb 1984
RAICHEM HDL-CHOLESTEROL REAGENT
K830207 · Reagents Applications, Inc. · Mar 1983
HDL REAGENT
K800996 · Gilford Diagnostics · May 1980
CHOL-HDL TEST, HIGH LIPO. CHOL TEST
K792313 · Sclavo, Inc. · Dec 1979
LANCER HDL SEPARATION KIT
K790865 · Sherwood Medical Co. · Jun 1979