Cleared Special

K061464 - VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541

Also marketed or referenced as:
CALIBRATOR KIT 4, MODEL 120 4668

K061464 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS TIBC KIT, manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JMO cleared through the Special 510(k) pathway after a 21-day FDA review.

K061464 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
21d
Days
Class 1
Risk

K061464 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on June 15, 2006 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1415 - 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 - K061464

510(k) Number K061464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2006
Decision Date June 15, 2006
Days to Decision 21 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
68d faster than avg
Panel avg: 89d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

JMO Device Classification - Class 1, General Controls

Product Code JMO Ferrozine (colorimetric) Iron Binding Capacity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1415
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JMO Ferrozine (colorimetric) Iron Binding Capacity

All 45
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K061464.
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
K113438 · Alfa Wassermann Diagnostic Technologies, Inc. · Jun 2012
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
K052867 · Ortho-Clinical Diagnostics, Inc. · Dec 2005
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
K041793 · Olympus America, Inc. · Jul 2004
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
K013102 · Wiener Laboratories Saic · Nov 2001
BAYER ADVIA SYSTEM
K012340 · Bayer Corp. · Oct 2001
DIRECT TIBC KIT
K000781 · Reference Diagnostics, Inc. · May 2000
K061464 · VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541
Download PDF FDA Summary Ortho-Clinical Diagno…