Cleared Traditional

K861244 - HDL/CHOLESTEROL TEST SYSTEM

K861244 is an FDA 510(k) clearance for HDL/CHOLESTEROL TEST SYSTEM, manufactured by Chrometrics Laboratories, Inc.. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K861244 · Chrometrics Laboratories, Inc. · Chemistry device
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Sep 1986
Decision
180d
Days
Class 1
Risk

K861244 is an FDA 510(k) clearance for the HDL/CHOLESTEROL TEST SYSTEM. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Chrometrics Laboratories, Inc. (Park Ridge, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 180 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Chrometrics Laboratories, Inc. devices

FDA 510(k) Submission Details - K861244

510(k) Number K861244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1986
Decision Date September 29, 1986
Days to Decision 180 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 88d · This submission: 180d
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 74
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K861244.
PARAMAX CHOLESTEROL REAGENT
K872050 · American Dade · Jul 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
HIGH DENSITY LIPOPROTEIN PRECIPITATIN
K843029 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
HDL EZ-TZ3 CHOLESTEROL REAGENT KIT
K840677 · Preventive Diagnostics Corp. · Apr 1984