Cleared Traditional

K021385 - ATAC PAK BUN REAGENT

K021385 is an FDA 510(k) clearance for ATAC PAK BUN REAGENT, manufactured by Elan Diagnostics. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K021385 · Elan Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
71d
Days
Class 2
Risk

K021385 is an FDA 510(k) clearance for the ATAC PAK BUN REAGENT. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Elan Diagnostics (Brea, US). The FDA issued a Cleared decision on July 12, 2002 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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 Elan Diagnostics devices

FDA 510(k) Submission Details - K021385

510(k) Number K021385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2002
Decision Date July 12, 2002
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDQ Device Classification - Class 2, Special Controls

Product Code CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 107
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K021385.
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
K070146 · Horiba Abx · Oct 2007
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
K060120 · Teco Diagnostics · Mar 2006
RAICHEM BUN RATE REAGENT (LIQUID)
K041051 · Hemagen Diagnostics, Inc. · Jun 2004
RAICHEM BUN RATE REAGENT
K012649 · Hemagen Diagnostics, Inc. · Oct 2001
WIENER LAB. UREA UV CINETICA AA
K012260 · Wiener Laboratories Saic · Sep 2001
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30
K002694 · Diagnostic Chemicals , Ltd. · Sep 2000