Cleared Special

K023784 - RAICHEM HDL CHOLESTEROL USING CANTROL H...

K023784 is the FDA 510(k) clearance for RAICHEM HDL CHOLESTEROL USING CANTROL H... by Hemagen Diagnostics, Inc.. It is a Class 1 Chemistry device (product code LBR) cleared through the Special 510(k) pathway after a 42-day FDA review.

K023784 · Hemagen Diagnostics, Inc. · Chemistry device
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Dec 2002
Decision
42d
Days
Class 1
Risk

K023784 is an FDA 510(k) clearance for the RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MI.... Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Hemagen Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on December 24, 2002 after a review of 42 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hemagen Diagnostics, Inc. devices

Submission Details

510(k) Number K023784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2002
Decision Date December 24, 2002
Days to Decision 42 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LBR Ldl & Vldl Precipitation, 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 - LBR Ldl & Vldl Precipitation, Hdl

All 33
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K023784.
DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR
K050823 · Teco Diagnostics · Jul 2005
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
K012593 · Ortho-Clinical Diagnostics, Inc. · Aug 2001
AUTOHDL CHOLESTEROL REAGENT SET
K992002 · Pointe Scientific, Inc., · Aug 1999
VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT
K984303 · Ortho-Clinical Diagnostics, Inc. · Jan 1999
HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51
K980772 · Diagnostic Chemicals , Ltd. · Apr 1998
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
K980770 · Diagnostic Chemicals , Ltd. · Apr 1998