Cleared Traditional

K972141 - THE YELLOW IRIS URINALYSIS WORKSTATION

K972141 is an FDA 510(k) clearance for THE YELLOW IRIS URINALYSIS WORKSTATION, manufactured by Intl. Remote Imaging Systems. The device is a Class 1 Chemistry device with product code KQO cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K972141 · Intl. Remote Imaging Systems · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
80d
Days
Class 1
Risk

K972141 is an FDA 510(k) clearance for the THE YELLOW IRIS URINALYSIS WORKSTATION. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Intl. Remote Imaging Systems (Chatsworth, US). The FDA issued a Cleared decision on August 25, 1997 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2900 - 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 Intl. Remote Imaging Systems devices

FDA 510(k) Submission Details - K972141

510(k) Number K972141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1997
Decision Date August 25, 1997
Days to Decision 80 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
8d faster than avg
Panel avg: 88d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

KQO Device Classification - Class 1, General Controls

Product Code KQO Automated Urinalysis System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2900
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 - KQO Automated Urinalysis System

All 32
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K972141.
BAYER CLINITEK STATUS ANALYZER
K031947 · Bayer Healthcare, LLC · Dec 2003
CHEMSTRIP 101 URINE ANALYZER
K983510 · Boehringer Mannheim Corp. · Oct 1998
URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER
K980047 · Yeongdong Pharmaceutical Corp. · Jun 1998
STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY
K954156 · Solarcare Technologies Corp,Inc. · Jul 1996
UA PERFECT AUTOMATED ANALYSIS ASSAY FOR UROBILLINOGEN IN URINE
K954514 · Sciteck Diagnostics, Inc. · Jun 1996
CLINITEK 50 URINE CHEMISTRY ANALYZER
K960546 · Bayer Corp. · Jun 1996