Cleared Traditional

K813192 - HDL-C EIKEN

K813192 is the FDA 510(k) clearance for HDL-C EIKEN by Syn-Kit, Inc.. It is a Class 1 Chemistry device (product code LBS) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K813192 · Syn-Kit, Inc. · Chemistry device
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Nov 1981
Decision
10d
Days
Class 1
Risk

K813192 is an FDA 510(k) clearance for the HDL-C EIKEN. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Syn-Kit, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1981 after a review of 10 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 Syn-Kit, Inc. devices

Submission Details

510(k) Number K813192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1981
Decision Date November 27, 1981
Days to Decision 10 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
78d faster than avg
Panel avg: 88d · This submission: 10d
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 K813192.
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
HIGH DENSITY LIPOPROTEIN PRECIPITATIN
K843029 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
HDL CHOLESTEROL TEST KIT
K801726 · Mallinckrodt Critical Care · Sep 1980
CENTRIFICHEM HDL CHOLESTEROL
K801133 · Union Carbide Corp. · Jun 1980
COULTER HDL CHOLESTEROL REAG. SYSTEM
K792319 · Coulter Electronics, Inc. · Dec 1979