Cleared Traditional

K053253 - HEMOCUE ALBUMIN 201 ANALYZING SYSTEM

K053253 is the FDA 510(k) clearance for HEMOCUE ALBUMIN 201 ANALYZING SYSTEM by Hemocue AB. It is a Class 1 Chemistry device (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

Submission Details

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.

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 19
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K053253.
CLINITEK NOVUS
K140717 · Siemens Healthcare Diagnostics · Nov 2014
COBAS U411 TEST SYSTEM
K093555 · Roche Diagnostics · Apr 2010
ACON U120 URINE ANALYZER, MODEL U111-101
K070929 · ACON Laboratories, Inc. · Jul 2007
CHEMSTRIP 101 URINE ANALYZER
K983510 · Boehringer Mannheim Corp. · Oct 1998
CLINITEK 50 URINE CHEMISTRY ANALYZER
K960546 · Bayer Corp. · Jun 1996
CHEMSTRIP CRITERION URINE ANALYZER
K954024 · Boehringer Mannheim Corp. · Oct 1995