Cleared Special

K014008 - HEMOCHRON JR. CITRATE APTT CUVETTE

K014008 is an FDA 510(k) clearance for HEMOCHRON JR. CITRATE APTT CUVETTE, manufactured by Itc, Inc.. The device is a Class 2 Hematology device with product code GFO cleared through the Special 510(k) pathway after a 50-day FDA review.

K014008 · Itc, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
50d
Days
Class 2
Risk

K014008 is an FDA 510(k) clearance for the HEMOCHRON JR. CITRATE APTT CUVETTE. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Itc, Inc. (Edison, US). The FDA issued a Cleared decision on January 24, 2002 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - the FDA hematology device 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 - K014008

510(k) Number K014008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2001
Decision Date January 24, 2002
Days to Decision 50 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 113d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

GFO Device Classification - Class 2, Special Controls

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 Hematology devices follow this clearance model.

Regulatory Peers - GFO Activated Partial Thromboplastin

All 51
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K014008.
HEMOSIL SILICA CLOTTING TIME
K050221 · Instrumentation Laboratory CO · Mar 2005
VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
K022021 · Vital Scientific N.V. · Nov 2002
CARESIDE APTT
K014028 · Careside Hemotology, Inc. · Feb 2002
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
K992711 · Sigma Diagnostics, Inc. · Dec 1999
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
K992712 · Sigma Diagnostics, Inc. · Dec 1999
HEMOCHRON CITRATE APTT
K972831 · International Technidyne Corp. · Nov 1997
K014008 · HEMOCHRON JR. CITRATE APTT CUVETTE
Download PDF FDA Summary Itc, Inc.