Cleared Traditional

ACE IRON REAGENT (K944911) - FDA 510(k) Clearance

Class I Chemistry device.

K944911 · Schiapparelli Biosystems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
128d
Days
Class 1
Risk

K944911 is an FDA 510(k) clearance for the ACE IRON REAGENT. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Schiapparelli Biosystems, Inc. (Columbia, US). The FDA issued a Cleared decision on February 10, 1995 after a review of 128 days - within the typical 510(k) review window.

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: 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 Schiapparelli Biosystems, Inc. devices

Submission Details

510(k) Number K944911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1994
Decision Date February 10, 1995
Days to Decision 128 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 88d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 66
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K944911.
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