Cleared Traditional

K080851 - A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY

K080851 is the FDA 510(k) clearance for A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY by Anticancer, Inc.. It is a Class 2 Chemistry device (product code LPS) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K080851 · Anticancer, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Oct 2008
Decision
198d
Days
Class 2
Risk

K080851 is an FDA 510(k) clearance for the A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY. Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Anticancer, Inc. (San Diego, US). The FDA issued a Cleared decision on October 10, 2008 after a review of 198 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1377 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Anticancer, Inc. devices

Submission Details

510(k) Number K080851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2008
Decision Date October 10, 2008
Days to Decision 198 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 88d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPS Urinary Homocystine (nonquantitative) Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1377
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - LPS Urinary Homocystine (nonquantitative) Test System

All 13
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K080851.
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III
K123930 · Ortho-Clinical Diagnostics, Inc. · May 2013
DIAZYME HOMOCYSTEINE POC TEST KIT
K121053 · Diazyme Laboratories · Jul 2012
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL
K071971 · Diazyme Laboratories · Sep 2007
TECO HOMOCYSTEINE ENZYMATIC ASSAY
K063701 · Teco Diagnostics · Apr 2007
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
K063206 · Dade Behring, Inc. · Dec 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
K061598 · Instrumentation Laboratory CO · Sep 2006