Cleared Traditional

K843029 - HIGH DENSITY LIPOPROTEIN PRECIPITATIN

K843029 is the FDA 510(k) clearance for HIGH DENSITY LIPOPROTEIN PRECIPITATIN by Diagnostic Chemicals, Ltd. (Usa). It is a Class 1 Chemistry device (product code LBS) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K843029 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Aug 1984
Decision
26d
Days
Class 1
Risk

K843029 is an FDA 510(k) clearance for the HIGH DENSITY LIPOPROTEIN PRECIPITATIN. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Canada, US). The FDA issued a Cleared decision on August 27, 1984 after a review of 26 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K843029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1984
Decision Date August 27, 1984
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
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 48
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K843029.
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
HDL-C EIKEN
K813192 · Syn-Kit, Inc. · Nov 1981
HDL CHOLESTEROL TEST KIT
K801726 · Mallinckrodt Critical Care · Sep 1980
CENTRIFICHEM HDL CHOLESTEROL
K801133 · Union Carbide Corp. · Jun 1980