Cleared Traditional

K972363 - IL TEST IRON

K972363 is an FDA 510(k) clearance for IL TEST IRON, manufactured by Instrumentation Laboratory CO. The device is a Class 1 Chemistry device with product code JIY cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K972363 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
51d
Days
Class 1
Risk

K972363 is an FDA 510(k) clearance for the IL TEST IRON. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on August 15, 1997 after a review of 51 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K972363

510(k) Number K972363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1997
Decision Date August 15, 1997
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
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 60
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K972363.
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003
K013097 · Wiener Laboratories Saic · Nov 2001
IRON
K981241 · Abbott Laboratories · May 1998
SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30
K973933 · Diagnostic Chemicals , Ltd. · Nov 1997
IRON REAGENT
K964913 · Derma Media Lab., Inc. · Feb 1997
TOTAL IRON (NITRO-PAPS) REAGENT SET
K961588 · Pointe Scientific, Inc., · Nov 1996
ACE IRON REAGENT
K944911 · Schiapparelli Biosystems, Inc. · Feb 1995