Cleared Traditional

K840064 - UREA NITROGEN REAGENT SET

K840064 is an FDA 510(k) clearance for UREA NITROGEN REAGENT SET, manufactured by Sterling Biochemical, Inc.. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K840064 · Sterling Biochemical, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1984
Decision
157d
Days
Class 2
Risk

K840064 is an FDA 510(k) clearance for the UREA NITROGEN REAGENT SET. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Sterling Biochemical, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1984 after a review of 157 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 Sterling Biochemical, Inc. devices

FDA 510(k) Submission Details - K840064

510(k) Number K840064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1984
Decision Date June 14, 1984
Days to Decision 157 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 88d · This submission: 157d
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 109
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K840064.
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
PARAMAX UREA NITROGEN REAGENT
K840785 · American Dade · Apr 1984
UREA NITROGEN-UV
K833931 · Seragen Diagnostics, Inc. · Jan 1984
BUN LIQUID STABLE REAGENT SET
K832941 · Medical Analysis Systems, Inc. · Oct 1983