Cleared Traditional

K053253 - HEMOCUE ALBUMIN 201 ANALYZING SYSTEM

K053253 is an FDA 510(k) clearance for HEMOCUE ALBUMIN 201 ANALYZING SYSTEM, manufactured by Hemocue AB. The device is a Class 1 Chemistry device with product code KQO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K053253 · Hemocue AB · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
88d
Days
Class 1
Risk

K053253 is an FDA 510(k) clearance for the HEMOCUE ALBUMIN 201 ANALYZING SYSTEM. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Hemocue AB (Lake Forest, US). The FDA issued a Cleared decision on February 17, 2006 after a review of 88 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 Hemocue AB devices

FDA 510(k) Submission Details - K053253

510(k) Number K053253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2005
Decision Date February 17, 2006
Days to Decision 88 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
At panel average
Panel avg: 88d · This submission: 88d
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 31
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K053253.
COBAS U411 TEST SYSTEM
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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