Cleared Abbreviated

ADVIA CHEMISTRY MICROALBUMIN CONTROLS (K052242) - FDA 510(k) Clearance

Class I Chemistry device.

K052242 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
47d
Days
Class 1
Risk

K052242 is an FDA 510(k) clearance for the ADVIA CHEMISTRY MICROALBUMIN CONTROLS. Classified as Urinalysis Controls (assayed And Unassayed) (product code JJW), Class I - General Controls.

Submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on October 3, 2005 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Bayer Healthcare, LLC devices

Submission Details

510(k) Number K052242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2005
Decision Date October 03, 2005
Days to Decision 47 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JJW Urinalysis Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJW Urinalysis Controls (assayed And Unassayed)

All 25
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K052242.
RANDOX URINE CONTROLS
K043266 · Randox Laboratories, Ltd. · Feb 2005
URICHEMTRAK LIQUID ASSAYED URINE CONTROL
K031441 · Medical Analysis Systems, Inc. · Jul 2003
LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS
K031231 · Bio-Rad · Jun 2003
MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL
K023928 · Medical Analysis Systems, Inc. · Dec 2002
MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL
K021155 · Medical Analysis Systems, Inc. · Apr 2002
URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100
K000874 · Bio-Rad · Apr 2000