Cleared Traditional

K052867 - VITROS CHEMISTRY PRODUCTS DTIBC REAGENT

K052867 is an FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS DTIBC REAGENT, manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JMO cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K052867 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
73d
Days
Class 1
Risk

K052867 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS DTIBC REAGENT. 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 December 23, 2005 after a review of 73 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortho-Clinical Diagnostics, Inc. devices

FDA 510(k) Submission Details - K052867

510(k) Number K052867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2005
Decision Date December 23, 2005
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

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 K052867.
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 TIBC KIT, MODEL 886 7541
K061464 · Ortho-Clinical Diagnostics, Inc. · Jun 2006
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