Cleared Traditional

J&S IRON REAGENTS (K912716) - FDA 510(k) Clearance

Class I Chemistry device.

K912716 · J.S. Medical Assoc. · Chemistry device
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Sep 1991
Decision
99d
Days
Class 1
Risk

K912716 is an FDA 510(k) clearance for the J&S IRON REAGENTS. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on September 25, 1991 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all J.S. Medical Assoc. devices

Submission Details

510(k) Number K912716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1991
Decision Date September 25, 1991
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
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 45
Devices cleared under the same product code (JMO) and FDA review panel - the closest regulatory comparables to K912716.
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K994115 · Dade Behring, Inc. · Jan 2000
UIBC
K982041 · Abbott Laboratories · Jul 1998
TIBC
K981654 · Abbott Laboratories · Jul 1998
TIBC
K981279 · Abbott Laboratories · May 1998
SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS
K960485 · Beckman Instruments, Inc. · May 1996
KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT
K931493 · Eastman Kodak Company · May 1993