Cleared Traditional

AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 (K900394) - FDA 510(k) Clearance

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

K900394 · American Research Products Co. · Chemistry device
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Apr 1990
Decision
72d
Days
Class 2
Risk

K900394 is an FDA 510(k) clearance for the AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by American Research Products Co. (Solon, US). The FDA issued a Cleared decision on April 11, 1990 after a review of 72 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 American Research Products Co. devices

Submission Details

510(k) Number K900394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1990
Decision Date April 11, 1990
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 88d · This submission: 72d
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 26
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K900394.
UREA NITROGEN TEST
K925002 · Em Diagnostic Systems, Inc. · Jan 1993
IL TEST(TM) UREA NITROGEN
K914877 · Instrumentation Laboratory CO · Mar 1992
UREA NITROGEN TEST
K903334 · Em Diagnostic Systems, Inc. · Sep 1990
BUN (KINETIC)
K895666 · Boehringer Mannheim Corp. · Oct 1989
UREA NITROGEN TEST (BUN) ITEM #65408
K894378 · Em Diagnostic Systems, Inc. · Aug 1989
UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
K884987 · Em Diagnostic Systems, Inc. · Jan 1989