Cleared Traditional

K063701 - TECO HOMOCYSTEINE ENZYMATIC ASSAY

K063701 is an FDA 510(k) clearance for TECO HOMOCYSTEINE ENZYMATIC ASSAY, manufactured by Teco Diagnostics. The device is a Class 2 Chemistry device with product code LPS cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K063701 · Teco Diagnostics · Chemistry device
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Apr 2007
Decision
119d
Days
Class 2
Risk

K063701 is an FDA 510(k) clearance for the TECO HOMOCYSTEINE ENZYMATIC ASSAY. Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on April 11, 2007 after a review of 119 days - within the typical 510(k) review window.

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 Teco Diagnostics devices

FDA 510(k) Submission Details - K063701

510(k) Number K063701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2006
Decision Date April 11, 2007
Days to Decision 119 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 88d · This submission: 119d
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 Chemistry devices follow this clearance model.

Regulatory Peers - LPS Urinary Homocystine (nonquantitative) Test System

All 20
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K063701.
AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100
K083222 · Axis-Shield Diagnostics, Ltd. · Jul 2009
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
K073640 · Axis-Shield Diagnostics, Ltd. · Apr 2008
DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL
K071971 · Diazyme Laboratories · Sep 2007
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
K063206 · Dade Behring, Inc. · Dec 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
K061598 · Instrumentation Laboratory CO · Sep 2006
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
K061588 · Ortho-Clinical Diagnostics, Inc. · Jul 2006