Cleared Traditional

K900902 - IRON LIQUID STABLE REAGENT

K900902 is the FDA 510(k) clearance for IRON LIQUID STABLE REAGENT by Medical Analysis Systems, Inc.. It is a Class 1 Chemistry device (product code JIY) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K900902 · Medical Analysis Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
20d
Days
Class 1
Risk

K900902 is an FDA 510(k) clearance for the IRON LIQUID STABLE REAGENT. Classified as Photometric Method, Iron (non-heme) (product code JIY), Class I - General Controls.

Submitted by Medical Analysis Systems, Inc. (Camarillo, US). The FDA issued a Cleared decision on March 19, 1990 after a review of 20 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 Medical Analysis Systems, Inc. devices

Submission Details

510(k) Number K900902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1990
Decision Date March 19, 1990
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
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 50
Devices cleared under the same product code (JIY) and FDA review panel - the closest regulatory comparables to K900902.
TOTAL IRON FOR MANUAL/AUTOMATED
K902877 · Catachem, Inc. · Jul 1990
COULTER SERUM IRON/UIBC REAGENT
K902173 · Coulter Corp. · Jun 1990
IRON/TOTAL IRON BINDING CAPACITY
K901561 · Tech-Co, Inc. · May 1990
SYSTEMATE(TM) IRON ITEM NUMBER: 65417
K895249 · Em Diagnostic Systems, Inc. · Oct 1989
IRON SYSTEM PACK REAGENTS
K892838 · Boehringer Mannheim Corp. · Jun 1989
EASY-TEST IRON (IRON) ITEM NO. 16686
K892863 · Em Diagnostic Systems, Inc. · Jun 1989