Cleared Traditional

K840785 - PARAMAX UREA NITROGEN REAGENT

K840785 is the FDA 510(k) clearance for PARAMAX UREA NITROGEN REAGENT by American Dade. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K840785 · American Dade · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
50d
Days
Class 2
Risk

K840785 is an FDA 510(k) clearance for the PARAMAX UREA NITROGEN REAGENT. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984 after a review of 50 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 Dade devices

Submission Details

510(k) Number K840785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1984
Decision Date April 05, 1984
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 87
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K840785.
SYSTEMATE BUN HEM NO. 67221
K843326 · Em Diagnostic Systems, Inc. · Sep 1984
UREA ASSAY KIT
K843057 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984
UREA ASSAY KIT
K842242 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984
BUN LIQUID STABLE REAGENT SET
K832941 · Medical Analysis Systems, Inc. · Oct 1983
ULTRA CHEM BUN-UV #65080-65081
K830241 · Emd Chemicals, Inc. · Apr 1983
AMRESCO UREA NITROGEN REAGENT SET
K830555 · Amresco, Inc. · Mar 1983