Cleared Traditional

K960054 - 900UDX URINE PATHOLOGY SYSTEM (FDA 510(k) Clearance)

Class I Hematology device.

K960054 · Intl. Remote Imaging Systems · Hematology device
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Optimized for regulatory review, auditing and printing
Mar 1996
Decision
78d
Days
Class 1
Risk

K960054 is an FDA 510(k) clearance for the 900UDX URINE PATHOLOGY SYSTEM. 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 March 22, 1996 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2900 - the FDA hematology 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: 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

Submission Details

510(k) Number K960054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1996
Decision Date March 22, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 113d · This submission: 78d
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.