Cleared Traditional

K780534 - UREA NITROGEN (ENZYMATIC)

K780534 is the FDA 510(k) clearance for UREA NITROGEN (ENZYMATIC) by Macomb Chemical Co.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K780534 · Macomb Chemical Co. · Chemistry device
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May 1978
Decision
46d
Days
Class 2
Risk

K780534 is an FDA 510(k) clearance for the UREA NITROGEN (ENZYMATIC). Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Macomb Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on May 19, 1978 after a review of 46 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 Macomb Chemical Co. devices

Submission Details

510(k) Number K780534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1978
Decision Date May 19, 1978
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
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 89
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K780534.
CENTRIFICHEM BUN
K800128 · Union Carbide Corp. · Feb 1980
BUN
K781782 · Gilford Diagnostics · Jan 1979
BUN TEST UNI-UV BLOOD UREA NITROGEN TEST
K780943 · Sclavo, Inc. · Jul 1978
BUN REAGNET SET
K780069 · Medical Analysis Systems, Inc. · Feb 1978
FASTCHEM BUN
K771923 · Boehringer Mannheim Corp. · Nov 1977
UN, UV DELTA TEST ASSAY
K770654 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1977