Cleared Special

K062092 - PREVU POINT OF CARE SKIN STEROL TEST

K062092 is an FDA 510(k) clearance for PREVU POINT OF CARE SKIN STEROL TEST, manufactured by Premd, Inc.. The device is a Class 1 Chemistry device with product code LBS cleared through the Special 510(k) pathway after a 53-day FDA review.

K062092 · Premd, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
53d
Days
Class 1
Risk

K062092 is an FDA 510(k) clearance for the PREVU POINT OF CARE SKIN STEROL TEST. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Premd, Inc. (Rockville, US). The FDA issued a Cleared decision on September 15, 2006 after a review of 53 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 Premd, Inc. devices

FDA 510(k) Submission Details - K062092

510(k) Number K062092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 24, 2006
Decision Date September 15, 2006
Days to Decision 53 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 88d · This submission: 53d
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 68
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K062092.
HDL CHOLESTEROL REAGENT, MODEL 10211
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ENVOY 500 HDL
K071706 · Clinical Data, Inc. · Dec 2007
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K053157 · Dade Behring, Inc. · Dec 2005
ULTRA HDL
K051962 · Abbott Laboratories · Aug 2005
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
K050632 · Bayer Healthcare, LLC · May 2005