Cleared Special

AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A (K053157) - FDA 510(k) Clearance

Class I Chemistry device.

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 79
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K053157.
ULTRA HDL
K051962 · Abbott Laboratories · Aug 2005
DIRECT HDL
K981224 · Abbott Laboratories · Aug 1998
HDL
K981580 · Abbott Laboratories · Jun 1998
IQ HDL CHOLESTEROL
K881891 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1988
VISION (TM) HDL CHOLESTEROL
K871461 · Abbott Laboratories · May 1987