Cleared Traditional

K845020 - SYSTE MATE IRON, HEM NO. 67224

K845020 is an FDA 510(k) clearance for SYSTE MATE IRON, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K845020 · Em Diagnostic Systems, Inc. · Chemistry device
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Jan 1985
Decision
32d
Days
Class 1
Risk

K845020 is an FDA 510(k) clearance for the SYSTE MATE IRON, HEM NO. 67224. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on January 28, 1985 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1410 - 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 - K845020

510(k) Number K845020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1984
Decision Date January 28, 1985
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

JIY Device Classification - Class 1, General Controls

Product Code JIY Photometric Method, Iron (non-heme)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1410
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 - JIY Photometric Method, Iron (non-heme)

All 61
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K845020.
ANALYTE IRON/TECHNICON CHEM 1 SYSTEM
K860799 · Technicon Instruments Corp. · Apr 1986
SERUM IRON & IRON BINDING REAGENT SET
K860478 · Sterling Diagnostics, Inc. · Mar 1986
SANDARE IRON PROCEDURE
K851394 · Sandare Chemical Co., Inc. · Apr 1985
TECHNICON RA-1000 SYS IRON FOR SERUM
K843255 · Technicon Instruments Corp. · Sep 1984
PARAMAX IRON REAGENT
K841886 · American Dade · Jun 1984
PARAMAX IRON BLANK REAGENT
K841887 · American Dade · Jun 1984