Cleared Traditional

K944250 - UREA NITROGEN REAGENT

K944250 is an FDA 510(k) clearance for UREA NITROGEN REAGENT, manufactured by Olympus Corp of America. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K944250 · Olympus Corp of America · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
160d
Days
Class 2
Risk

K944250 is an FDA 510(k) clearance for the UREA NITROGEN REAGENT. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Olympus Corp of America (Lake Success, US). The FDA issued a Cleared decision on February 8, 1995 after a review of 160 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 Olympus Corp of America devices

FDA 510(k) Submission Details - K944250

510(k) Number K944250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1994
Decision Date February 08, 1995
Days to Decision 160 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
72d slower than avg
Panel avg: 88d · This submission: 160d
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 91
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K944250.
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
UREA KIT
K923506 · Randox Laboratories, Ltd. · Sep 1993
UREA NITROGEN TEST ITEM NUMBER 65408
K932161 · Em Diagnostic Systems, Inc. · Sep 1993
OLYMPUS REPLY UREA NITROGEN REAGENT
K931745 · Olympus Corp. · Aug 1993