Cleared Traditional

HDL/CHOLESTEROL TEST SYSTEM (K861244) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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.

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 21
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K861244.
ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL
K871265 · E.I. Dupont DE Nemours & Co., Inc. · Aug 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
CHOLESTEROL KIT, HDL-DS
K790553 · Beckman Instruments, Inc. · Jun 1979