Cleared Traditional

K842505 - TDX REA IRON DIAGNOSTIC KIT

K842505 is an FDA 510(k) clearance for TDX REA IRON DIAGNOSTIC KIT, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code CFM cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K842505 · Abbott Laboratories · Chemistry device
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Aug 1984
Decision
42d
Days
Class 1
Risk

K842505 is an FDA 510(k) clearance for the TDX REA IRON DIAGNOSTIC KIT. Classified as Bathophenanthroline, Colorimetry, Iron (non-heme) (product code CFM), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 7, 1984 after a review of 42 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K842505

510(k) Number K842505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1984
Decision Date August 07, 1984
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

CFM Device Classification - Class 1, General Controls

Product Code CFM Bathophenanthroline, Colorimetry, 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 - CFM Bathophenanthroline, Colorimetry, Iron (non-heme)

All 17
Devices cleared under the same product code (CFM) and FDA review panel - the closest regulatory comparables to K842505.
DATA CHEM IRON PROCEDURE
K852583 · Data Medical Associates, Inc. · Jul 1985
SERUM IRON & SERUM IRON BINDING CAPACI
K842155 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
SERUM IRON & SERUM IRON BINDING CAPACITY
K842156 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
FEB TEST
K830564 · Wako Chemicals USA, Inc. · Mar 1983
CORNING 902 SODIUM POTASSIUM ANALYZER
K820629 · Corning Medical & Scientific · Mar 1982
ELVI SERUM IRON
K792406 · Volu Sol Medical Industries · Dec 1979