Cleared Traditional

K993107 - BIO-RAD HOMOCYSTEINE BY HPLC

K993107 is the FDA 510(k) clearance for BIO-RAD HOMOCYSTEINE BY HPLC by Bio-Rad. It is a Class 2 Toxicology device (product code LPS) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K993107 · Bio-Rad · Toxicology device
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Dec 1999
Decision
95d
Days
Class 2
Risk

K993107 is an FDA 510(k) clearance for the BIO-RAD HOMOCYSTEINE BY HPLC. Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Bio-Rad (Hercules, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 95 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.

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Submission Details

510(k) Number K993107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1999
Decision Date December 21, 1999
Days to Decision 95 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 87d · This submission: 95d
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.

Regulatory Peers - LPS Urinary Homocystine (nonquantitative) Test System

All 12
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K993107.
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788 · Dade Behring, Inc. · Mar 2006
HOMOCYSTEINE MICROTITER PLATE ASSAY
K032012 · Diazyme Laboratories · Sep 2003
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597 · Diagnostic Products Corp. · Feb 2001
ABBOTT AXSYM HOMOCYSTEINE
K992858 · Abbott Laboratories · Oct 1999