Cleared Traditional

K850128 - SYSTE MATE TIBC HEM NO. 67225

K850128 is an FDA 510(k) clearance for SYSTE MATE TIBC HEM NO. 67225, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code JMO cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K850128 · Em Diagnostic Systems, Inc. · Chemistry device
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Feb 1985
Decision
18d
Days
Class 1
Risk

K850128 is an FDA 510(k) clearance for the SYSTE MATE TIBC HEM NO. 67225. Classified as Ferrozine (colorimetric) Iron Binding Capacity (product code JMO), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on February 1, 1985 after a review of 18 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K850128

510(k) Number K850128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date February 01, 1985
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
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 K850128.
AMRESCO FLOW PAC TOTAL IRON REAGENT SET #1241
K863426 · American Research Products Co. · Sep 1986
TDX REA IRON/TIBC
K851930 · Abbott Laboratories · May 1985
SANDARE IRON-BINDING CAPACITY PROCEDURE
K851395 · Sandare Chemical Co., Inc. · May 1985
TOTAL IRON-BINDING CAPACITY ACCESORY
K832759 · Seragen Diagnostics, Inc. · Oct 1983
SERUM UIBC-PTF-600 METHOD
K831202 · American Monitor Corp. · May 1983
IRON BINDING CAPACITY CHEMISTRY
K780094 · Harleco · Feb 1978