Cleared Traditional

AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123 (K891912) - FDA 510(k) Clearance

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

K891912 · American Research Products Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1989
Decision
84d
Days
Class 2
Risk

K891912 is an FDA 510(k) clearance for the AMRESCO UREA NITROGEN (BUN) REAGENTS, PROD # 7123. 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 June 19, 1989 after a review of 84 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 K891912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1989
Decision Date June 19, 1989
Days to Decision 84 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 88d · This submission: 84d
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 K891912.
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
BUN (KINETIC)
K881677 · Boehringer Mannheim Corp. · Jun 1988
PARAMAX UREA NITROGEN REAGENT
K873532 · Baxter Healthcare Corp · Nov 1987