Cleared Traditional

K880546 - TOTAL IRON BINDING CAPACITY (TIBC)

K880546 is an FDA 510(k) clearance for TOTAL IRON BINDING CAPACITY (TIBC), manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Chemistry device with product code JMO cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K880546 · Boehringer Mannheim Corp. · Chemistry device
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Mar 1988
Decision
44d
Days
Class 1
Risk

K880546 is an FDA 510(k) clearance for the TOTAL IRON BINDING CAPACITY (TIBC). Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 44 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K880546

510(k) Number K880546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1988
Decision Date March 24, 1988
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 88d · This submission: 44d
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 33
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K880546.
IRON REAGENTS PRODUCT CODES 7725 AND 7726
K901960 · American Research Products Co. · May 1990
CHEM 1 UIBC (IRON BINDING CAPACITY TEST)
K883104 · Technicon Instruments Corp. · Oct 1988
UNSATURATED IRON BINDING CAPACITY
K881761 · Data Medical Associates, Inc. · Jul 1988
IRON REAGENT
K874055 · Trace Scientific , Ltd. · Oct 1987
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
K871414 · Em Diagnostic Systems, Inc. · Apr 1987
AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241
K863426 · American Research Products Co. · Sep 1986