Cleared Traditional

K021428 - CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM

K021428 is an FDA 510(k) clearance for CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM, manufactured by Bayer Corp.. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K021428 · Bayer Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
63d
Days
Class 2
Risk

K021428 is an FDA 510(k) clearance for the CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on July 5, 2002 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 Bayer Corp. devices

FDA 510(k) Submission Details - K021428

510(k) Number K021428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2002
Decision Date July 05, 2002
Days to Decision 63 days
Submission Type Traditional
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
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFY Device Classification - Class 2, Special Controls

Product Code JFY Enzymatic Method, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JFY Enzymatic Method, Creatinine

All 41
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K021428.
POLY-CHEM CREATININE
K061944 · Polymedco, Inc. · Nov 2006
CREATININE LIQUICOLOR
K050283 · Stanbio Laboratory · Jun 2005
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098 · Roche Diagnostics Corp. · Dec 2002
WIENER LAB. CREATININA CINETICA AA
K012065 · Wiener Laboratories Saic · Oct 2001
BIOSCANNER CREATININE TEST STRIPS
K010456 · Polymer Technology Systems, Inc. · Jun 2001
CREATININE PLUS
K003261 · Roche Diagnostics Corp. · Nov 2000