Cleared Traditional

K030600 - AUTION JET AJ-4270 URINE ANALYZER

K030600 is an FDA 510(k) clearance for AUTION JET AJ-4270 URINE ANALYZER, manufactured by International Remote Imaging Systems. The device is a Class 1 Chemistry device with product code KQO cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K030600 · International Remote Imaging Systems · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
136d
Days
Class 1
Risk

K030600 is an FDA 510(k) clearance for the AUTION JET AJ-4270 URINE ANALYZER. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by International Remote Imaging Systems (North Attleboro, US). The FDA issued a Cleared decision on July 11, 2003 after a review of 136 days - within the typical 510(k) review window.

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

View all International Remote Imaging Systems devices

FDA 510(k) Submission Details - K030600

510(k) Number K030600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2003
Decision Date July 11, 2003
Days to Decision 136 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 88d · This submission: 136d
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 K030600.
URITEK-720+ URINE ANALYZER
K051526 · Teco Diagnostics · Aug 2005
URITEK 151 URINE ANALYZER, MODEL TC-151
K042421 · Teco Diagnostics · May 2005
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
THE YELLOW IRIS URINALYSIS WORKSTATION
K972141 · Intl. Remote Imaging Systems · Aug 1997