Cleared Traditional

UREA NITROGEN (BUN) LIQUI-UV (K962418) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K962418 · Stanbio Laboratory · Chemistry device
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Dec 1996
Decision
185d
Days
Class 2
Risk

K962418 is an FDA 510(k) clearance for the UREA NITROGEN (BUN) LIQUI-UV. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on December 26, 1996 after a review of 185 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Stanbio Laboratory devices

Submission Details

510(k) Number K962418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1996
Decision Date December 26, 1996
Days to Decision 185 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
97d slower than avg
Panel avg: 88d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K962418.
Urea Nitrogen2
K203771 · Abbott Ireland Diagnostics Division · May 2022
UREA
K981918 · Abbott Laboratories · Jul 1998
IL TEST UREA NITROGEN
K974337 · Instrumentation Laboratory CO · Dec 1997
ROCHE REAGENT FOR BUN
K954000 · Roche Diagnostic Systems, Inc. · Oct 1995
IL TEST(TM) UREA NITROGEN
K914877 · Instrumentation Laboratory CO · Mar 1992
BUN (KINETIC)
K895666 · Boehringer Mannheim Corp. · Oct 1989