Cleared Traditional

K863260 - BLOOD UREA NITROGEN(BUN) PROCEDURE

K863260 is the FDA 510(k) clearance for BLOOD UREA NITROGEN(BUN) PROCEDURE by Data Medical Associates, Inc.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K863260 · Data Medical Associates, Inc. · Chemistry device
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Sep 1986
Decision
15d
Days
Class 2
Risk

K863260 is an FDA 510(k) clearance for the BLOOD UREA NITROGEN(BUN) PROCEDURE. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on September 9, 1986 after a review of 15 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K863260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date September 09, 1986
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 K863260.
MODIFIED ENZYMATIC BUN REAGENT
K872484 · Trace Scientific , Ltd. · Aug 1987
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
K870571 · Em Diagnostic Systems, Inc. · Mar 1987
UREA NITROGEN(BUN)
K863925 · Tech-Co, Inc. · Nov 1986
BUN (RATE) REAGENT
K863196 · Sigma Diagnostics, Inc. · Aug 1986
BLOOD UREA NITROGEN (BUN) PROCEDURE
K861666 · Data Medical Associates, Inc. · Jul 1986
UREA NITROGEN (GLDH) REAGENT SET (UV)
K862210 · Sterling Diagnostics, Inc. · Jul 1986