Cleared Traditional

K830220 - YELLOW IRIS TM

K830220 is the FDA 510(k) clearance for YELLOW IRIS TM by Intl. Remote Imaging Systems. It is a Class 1 Pathology device (product code KQO) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K830220 · Intl. Remote Imaging Systems · Pathology device
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Jun 1983
Decision
144d
Days
Class 1
Risk

K830220 is an FDA 510(k) clearance for the YELLOW IRIS TM. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Intl. Remote Imaging Systems (Mchenry, US). The FDA issued a Cleared decision on June 17, 1983 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.2900 - the FDA pathology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Intl. Remote Imaging Systems devices

Submission Details

510(k) Number K830220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1983
Decision Date June 17, 1983
Days to Decision 144 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 77d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 22
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K830220.
CLINI-TEK AUTO 2000 REFLECTANCE SPECTR
K841041 · Miles Laboratories, Inc. · Aug 1984
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
K842237 · Miles Laboratories, Inc. · Aug 1984
CLINITEK 10 SEMI-AUTO URINALYSIS SYS
K842238 · Miles Laboratories, Inc. · Jul 1984
CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST
K821738 · Miles Laboratories, Inc. · Jul 1982
CLINILAB AUTOMATED URINALYSIS SYSTEM
K761306 · Miles Laboratories, Inc. · Mar 1977
INSTRUMENTED SYSTEM FOR URINALYSIS
K760472 · Miles Laboratories, Inc. · Oct 1976