Cleared Abbreviated

K052242 - ADVIA CHEMISTRY MICROALBUMIN CONTROLS

K052242 is an FDA 510(k) clearance for ADVIA CHEMISTRY MICROALBUMIN CONTROLS, manufactured by Bayer Healthcare, LLC. The device is a Class 1 Chemistry device with product code JJW cleared through the Abbreviated 510(k) pathway after a 47-day FDA review.

K052242 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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

FDA 510(k) Submission Details - K052242

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Standards-based clearance path.

JJW Device Classification - Class 1, General Controls

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 48
Devices cleared under the same product code (JJW) and FDA review panel - the closest regulatory comparables to K052242.
CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
K081908 · Cliniqa Corporation · Jan 2009
IRISPEC,CA/CB/CC
K072640 · Iris Diagnostics · Dec 2007
LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X
K070848 · Bio-Rad, Diagnostics Grp. · Apr 2007
RANDOX URINE CONTROLS
K043266 · Randox Laboratories, Ltd. · Feb 2005
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
K042446 · Bio-Rad Laboratories, Inc. · Nov 2004
URICHEMTRAK LIQUID ASSAYED URINE CONTROL
K031441 · Medical Analysis Systems, Inc. · Jul 2003