Cleared Traditional

A/C ENZYMATIC HOMOCYSTEINE ASSAY (K030754) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 Toxicology devices follow this clearance model.