Cleared Traditional

K923569 - PARAMAX TOTAL IRON BINDING CAPACITY PRE...

K923569 is the FDA 510(k) clearance for PARAMAX TOTAL IRON BINDING CAPACITY PRE... by Baxter Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JMO) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K923569 · Baxter Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
40d
Days
Class 1
Risk

K923569 is an FDA 510(k) clearance for the PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by Baxter Diagnostics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on August 26, 1992 after a review of 40 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 Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K923569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1992
Decision Date August 26, 1992
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

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 33
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K923569.
IRON/UIBC REAGENT
K932517 · Sigma Diagnostics, Inc. · Nov 1993
KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT
K933329 · King Diagnostics, Inc. · Oct 1993
KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
K931493 · Eastman Kodak Company · May 1993
SYNERMED UIBC REAGENT KIT
K922784 · Synermed, Inc. · Jul 1992
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
K913922 · Em Diagnostic Systems, Inc. · Sep 1991
BIOTROL UIBC REAGENT
K912795 · Biotrol, USA, Inc. · Aug 1991