Cleared Traditional

K061598 - HEMOSIL HOMOCYSTEINE AND CONTROLS

K061598 is an FDA 510(k) clearance for HEMOSIL HOMOCYSTEINE AND CONTROLS, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Chemistry device with product code LPS cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K061598 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
106d
Days
Class 2
Risk

K061598 is an FDA 510(k) clearance for the HEMOSIL HOMOCYSTEINE AND CONTROLS. Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on September 22, 2006 after a review of 106 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K061598

510(k) Number K061598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2006
Decision Date September 22, 2006
Days to Decision 106 days
Submission Type Traditional
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
18d slower than avg
Panel avg: 88d · This submission: 106d
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 23
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K061598.
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
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
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788 · Dade Behring, Inc. · Mar 2006