Cleared Traditional

K954000 - ROCHE REAGENT FOR BUN

K954000 is the FDA 510(k) clearance for ROCHE REAGENT FOR BUN by Roche Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K954000 · Roche Diagnostic Systems, Inc. · Chemistry device
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Oct 1995
Decision
61d
Days
Class 2
Risk

K954000 is an FDA 510(k) clearance for the ROCHE REAGENT FOR BUN. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on October 25, 1995 after a review of 61 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K954000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1995
Decision Date October 25, 1995
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 88d · This submission: 61d
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 82
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K954000.
UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30
K973931 · Diagnostic Chemicals , Ltd. · Nov 1997
BUN (LIQUID) REAGENT SET
K972671 · Pointe Scientific, Inc., · Jul 1997
UREA NITROGEN (BUN) LIQUI-UV
K962418 · Stanbio Laboratory · Dec 1996
BLOOD UREA NITROGEN REAGENT SYSTEM
K952742 · Medical Diagnostic Technologies, Inc. · Aug 1995
BUN REAGENT
K942984 · American Research Products Co. · Mar 1995
UREA KIT
K923506 · Randox Laboratories, Ltd. · Sep 1993