Cleared Traditional

K801133 - CENTRIFICHEM HDL CHOLESTEROL

K801133 is an FDA 510(k) clearance for CENTRIFICHEM HDL CHOLESTEROL, manufactured by Union Carbide Corp.. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K801133 · Union Carbide Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1980
Decision
36d
Days
Class 1
Risk

K801133 is an FDA 510(k) clearance for the CENTRIFICHEM HDL CHOLESTEROL. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1980 after a review of 36 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K801133

510(k) Number K801133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1980
Decision Date June 17, 1980
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
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 52
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K801133.
HIGH DENSITY LIPOPROTEIN PRECIPITATIN
K843029 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
HDL-C EIKEN
K813192 · Syn-Kit, Inc. · Nov 1981
HDL CHOLESTEROL TEST KIT
K801726 · Mallinckrodt Critical Care · Sep 1980
COULTER HDL CHOLESTEROL REAG. SYSTEM
K792319 · Coulter Electronics, Inc. · Dec 1979
DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
K792183 · Dade, Baxter Travenol Diagnostics, Inc. · Nov 1979
TECHNICON HDL CHOLESTEROL METHOD
K791990 · Technicon Instruments Corp. · Oct 1979