Cleared Special

K053157 - AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A

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

K053157 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K053157

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.

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 78
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K053157.
CHOLESTRAK HDL CHOLESTEROL HOME TEST
K072836 · Accutech, LLC · Dec 2007
ENVOY 500 HDL
K071706 · Clinical Data, Inc. · Dec 2007
PREVU POINT OF CARE SKIN STEROL TEST
K062092 · Premd, Inc. · Sep 2006
ULTRA HDL
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
K053157 · AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
Download PDF FDA Summary Dade Behring, Inc.