Cleared Traditional

A-GENT UREA NITROGEN (K810794) - FDA 510(k) Clearance

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

K810794 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1981
Decision
9d
Days
Class 2
Risk

K810794 is an FDA 510(k) clearance for the A-GENT UREA NITROGEN. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 1, 1981 after a review of 9 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 Abbott Laboratories devices

Submission Details

510(k) Number K810794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1981
Decision Date April 01, 1981
Days to Decision 9 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 88d · This submission: 9d
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 40
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K810794.
PARAMAX UREA NITROGEN REAGENT
K840785 · American Dade · Apr 1984
LANCER MSA BUN DIAG. KIT
K821562 · Sherwood Medical Co. · Jun 1982
FUN-UV SYSTEM PACK TEST
K812290 · Boehringer Mannheim Corp. · Aug 1981
FASTCHEM BUN
K771923 · Boehringer Mannheim Corp. · Nov 1977
UN, UV DELTA TEST ASSAY
K770654 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1977
ENZYMATIC BUN (RATE) REAGENT KIT
K761261 · Beckman Instruments, Inc. · Dec 1976