Cleared Traditional

K981241 - IRON

K981241 is an FDA 510(k) clearance for IRON, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K981241 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
25d
Days
Class 1
Risk

K981241 is an FDA 510(k) clearance for the IRON. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on May 1, 1998 after a review of 25 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 - K981241

510(k) Number K981241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1998
Decision Date May 01, 1998
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
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 57
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K981241.
VITALAB IRON REAGENT
K033983 · Clinical Data, Inc. · May 2004
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
K020816 · Diagnostic Chemicals , Ltd. · May 2002
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
K013097 · Wiener Laboratories Saic · Nov 2001
SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30
K973933 · Diagnostic Chemicals , Ltd. · Nov 1997
IL TEST IRON
K972363 · Instrumentation Laboratory CO · Aug 1997
TOTAL IRON (NITRO-PAPS) REAGENT SET
K961588 · Pointe Scientific, Inc., · Nov 1996