Cleared Traditional

K960115 - HICHEM BUN/UREA REAGENT KIT

K960115 is an FDA 510(k) clearance for HICHEM BUN/UREA REAGENT KIT, manufactured by Elan Pharma, Inc.. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K960115 · Elan Pharma, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
78d
Days
Class 2
Risk

K960115 is an FDA 510(k) clearance for the HICHEM BUN/UREA REAGENT KIT. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Elan Pharma, Inc. (Brea, US). The FDA issued a Cleared decision on March 29, 1996 after a review of 78 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 Pharma, Inc. devices

FDA 510(k) Submission Details - K960115

510(k) Number K960115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1996
Decision Date March 29, 1996
Days to Decision 78 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
10d faster than avg
Panel avg: 88d · This submission: 78d
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 106
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K960115.
BUN
K971967 · Carolina Liquid Chemistries Corp. · Jun 1997
UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
K971477 · Trace America, Inc. · May 1997
UREA NITROGEN (BUN) LIQUI-UV
K962418 · Stanbio Laboratory · Dec 1996
ROCHE REAGENT FOR BUN
K954000 · Roche Diagnostic Systems, Inc. · Oct 1995
BLOOD UREA NITROGEN REAGENT SYSTEM
K952742 · Medical Diagnostic Technologies, Inc. · Aug 1995
BUN REAGENT
K942984 · American Research Products Co. · Mar 1995