Cleared Traditional

K072836 - CHOLESTRAK HDL CHOLESTEROL HOME TEST

K072836 is an FDA 510(k) clearance for CHOLESTRAK HDL CHOLESTEROL HOME TEST, manufactured by Accutech, LLC. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K072836 · Accutech, LLC · Chemistry device
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Dec 2007
Decision
85d
Days
Class 1
Risk

K072836 is an FDA 510(k) clearance for the CHOLESTRAK HDL CHOLESTEROL HOME TEST. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Accutech, LLC (East Stroudsburg, US). The FDA issued a Cleared decision on December 27, 2007 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Accutech, LLC devices

FDA 510(k) Submission Details - K072836

510(k) Number K072836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2007
Decision Date December 27, 2007
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 88d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

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 67
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K072836.
APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201
K080125 · Wako Chemicals USA, Inc. · Jul 2008
HDL CHOLESTEROL REAGENT, MODEL 10211
K073497 · Medica Corp. · Apr 2008
DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
K072395 · Diazyme Laboratories · Jan 2008
ENVOY 500 HDL
K071706 · Clinical Data, Inc. · Dec 2007
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
K053157 · Dade Behring, Inc. · Dec 2005
ULTRA HDL
K051962 · Abbott Laboratories · Aug 2005