Cleared Special

K062808 - LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT

K062808 is an FDA 510(k) clearance for LIQUID STABLE (LS) 2-PART HOMOCYSTEINE ..., manufactured by Catch Incorporated. The device is a Class 2 Chemistry device with product code LPS cleared through the Special 510(k) pathway after a 24-day FDA review.

K062808 · Catch Incorporated · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
24d
Days
Class 2
Risk

K062808 is an FDA 510(k) clearance for the LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT. Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Catch Incorporated (Renton, US). The FDA issued a Cleared decision on October 13, 2006 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1377 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K062808

510(k) Number K062808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2006
Decision Date October 13, 2006
Days to Decision 24 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

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 28
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K062808.
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
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
K061588 · Ortho-Clinical Diagnostics, Inc. · Jul 2006
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR
K061296 · Diazyme Laboratories · Jun 2006
K062808 · LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT
Download PDF FDA Summary Catch Incorporated