Cleared Traditional

K994115 - TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE

K994115 is an FDA 510(k) clearance for TOTAL IRON BINDING CAPACITY (IBCT) FLEX..., manufactured by Dade Behring, Inc.. The device is a Class 1 Chemistry device with product code JMO cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K994115 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Jan 2000
Decision
53d
Days
Class 1
Risk

K994115 is an FDA 510(k) clearance for the TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on January 28, 2000 after a review of 53 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K994115

510(k) Number K994115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1999
Decision Date January 28, 2000
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
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 K994115.
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
TIBC, PRODUCT NO'S 123-0, 123-02, FE109-01, FE109-02
K991666 · A.P. Total Care, Inc. · Jun 1999
TOTAL IRON, MODELS FE 109-01, FE 109-02
K991244 · A.P. Total Care, Inc. · May 1999
MAGNETIC TIBC KIT
K990216 · Reference Diagnostics, Inc. · Feb 1999