Cleared Special

K053157 - AUTOMATED HDL CHOLESTEROL FLEX REAGENT ...

K053157 is the FDA 510(k) clearance for AUTOMATED HDL CHOLESTEROL FLEX REAGENT ... by Dade Behring, Inc.. It is a Class 1 Chemistry device (product code LBS) cleared through the Special 510(k) pathway after a 25-day FDA review.

K053157 · Dade Behring, Inc. · Chemistry device
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Dec 2005
Decision
25d
Days
Class 1
Risk

K053157 is an FDA 510(k) clearance for the AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Dade Behring, Inc. (Newark,, US). The FDA issued a Cleared decision on December 9, 2005 after a review of 25 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K053157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2005
Decision Date December 09, 2005
Days to Decision 25 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 42
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K053157.
HDL CHOLESTEROL (HDLX) ASSAY
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K080125 · Wako Chemicals USA, Inc. · Jul 2008
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K073497 · Medica Corp. · Apr 2008
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K051962 · Abbott Laboratories · Aug 2005
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
K050632 · Bayer Healthcare, LLC · May 2005
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
K041928 · Diagnostic Chemicals , Ltd. · Nov 2004