Cleared Traditional

K912795 - BIOTROL UIBC REAGENT

K912795 is the FDA 510(k) clearance for BIOTROL UIBC REAGENT by Biotrol, USA, Inc.. It is a Class 1 Chemistry device (product code JMO) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K912795 · Biotrol, USA, Inc. · Chemistry device
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Aug 1991
Decision
48d
Days
Class 1
Risk

K912795 is an FDA 510(k) clearance for the BIOTROL UIBC REAGENT. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by Biotrol, USA, Inc. (Westchester, US). The FDA issued a Cleared decision on August 12, 1991 after a review of 48 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 Biotrol, USA, Inc. devices

Submission Details

510(k) Number K912795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1991
Decision Date August 12, 1991
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
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 K912795.
PARAMAX TOTAL IRON BINDING CAPACITY PRETREATMENT
K923569 · Baxter Diagnostics, Inc. · Aug 1992
SYNERMED UIBC REAGENT KIT
K922784 · Synermed, Inc. · Jul 1992
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
K913922 · Em Diagnostic Systems, Inc. · Sep 1991
IRON 5 X CONC REAGENT
K904116 · Trace Scientific , Ltd. · Sep 1990
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