Cleared Traditional

IRON/TIBC REAGENT (K935712) - FDA 510(k) Clearance

Class I Chemistry device.

K935712 · Horizon Diagnostics, Inc. · Chemistry device
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Sep 1995
Decision
659d
Days
Class 1
Risk

K935712 is an FDA 510(k) clearance for the IRON/TIBC REAGENT. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Horizon Diagnostics, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on September 20, 1995 after a review of 659 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Horizon Diagnostics, Inc. devices

Submission Details

510(k) Number K935712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1993
Decision Date September 20, 1995
Days to Decision 659 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
571d slower than avg
Panel avg: 88d · This submission: 659d
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
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