Cleared Traditional

BLOOD UREA NITROGEN (BUN) TESTCARD (K860543) - FDA 510(k) Clearance

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

K860543 · Ilex Corp. · Chemistry device
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Apr 1986
Decision
67d
Days
Class 2
Risk

K860543 is an FDA 510(k) clearance for the BLOOD UREA NITROGEN (BUN) TESTCARD. Classified as Electrode, Ion Specific, Urea Nitrogen (product code CDS), Class II - Special Controls.

Submitted by Ilex Corp. (Attleboro, US). The FDA issued a Cleared decision on April 21, 1986 after a review of 67 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 Ilex Corp. devices

Submission Details

510(k) Number K860543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1986
Decision Date April 21, 1986
Days to Decision 67 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 88d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDS Electrode, Ion Specific, 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 - CDS Electrode, Ion Specific, Urea Nitrogen

All 14
Devices cleared under the same product code (CDS) and FDA review panel - the closest regulatory comparables to K860543.
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
K171247 · Epocal, Inc. · Jan 2018
LANCER BUN RATE REAGENT KIT
K812308 · Sherwood Medical Co. · Aug 1981
BLOOD-UREA-NITROGEN (BUN) ANALYZER 2
K761061 · Beckman Instruments, Inc. · Jan 1977
BUN-REATIVE
K760430 · Boehringer Mannheim Corp. · Nov 1976