Cleared Special

VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541 (K061464) - FDA 510(k) Clearance

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

Class I Chemistry device.

K061464 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (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.

View all Ortho-Clinical Diagnostics, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K994115 · Dade Behring, Inc. · Jan 2000
UIBC
K982041 · Abbott Laboratories · Jul 1998
TIBC
K981654 · Abbott Laboratories · Jul 1998
TIBC
K981279 · Abbott Laboratories · May 1998
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
K960485 · Beckman Instruments, Inc. · May 1996
KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
K931493 · Eastman Kodak Company · May 1993