Cleared Traditional

K030754 - A/C ENZYMATIC HOMOCYSTEINE ASSAY

K030754 is an FDA 510(k) clearance for A/C ENZYMATIC HOMOCYSTEINE ASSAY, manufactured by Anticancer, Inc.. The device is a Class 2 Toxicology device with product code LPS cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K030754 · Anticancer, Inc. · Toxicology device
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Jul 2003
Decision
123d
Days
Class 2
Risk

K030754 is an FDA 510(k) clearance for the A/C 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 July 11, 2003 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1377 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Anticancer, Inc. devices

FDA 510(k) Submission Details - K030754

510(k) Number K030754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2003
Decision Date July 11, 2003
Days to Decision 123 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 87d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPS Device Classification - Class 2, Special Controls

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 Toxicology devices follow this clearance model.

Regulatory Peers - LPS Urinary Homocystine (nonquantitative) Test System

All 26
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K030754.
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788 · Dade Behring, Inc. · Mar 2006
POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS
K033706 · Polymedco, Inc. · Feb 2004
HOMOCYSTEINE MICROTITER PLATE ASSAY
K032012 · Diazyme Laboratories · Sep 2003
ACS 180 HOMOCYSTEINE ASSAY
K013606 · Bayer Diagnostics Corp. · Dec 2001
ADVIA CENTAUR HOMOCYSTEINE ASSAY
K013406 · Bayer Diagnostics Corp. · Dec 2001
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
K011692 · Intersect Systems, Inc. · Jul 2001