Cleared Traditional

K171247 - epoc Blood Urea Nitrogen Test

K171247 is the FDA 510(k) clearance for epoc Blood Urea Nitrogen Test by Epocal, Inc.. It is a Class 2 Chemistry device (product code CDS) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K171247 · Epocal, Inc. · Chemistry device
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Jan 2018
Decision
264d
Days
Class 2
Risk

K171247 is an FDA 510(k) clearance for the epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test. Classified as Electrode, Ion Specific, Urea Nitrogen (product code CDS), Class II - Special Controls.

Submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on January 17, 2018 after a review of 264 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 Epocal, Inc. devices

Submission Details

510(k) Number K171247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2017
Decision Date January 17, 2018
Days to Decision 264 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 88d · This submission: 264d
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 7
Devices cleared under the same product code (CDS) and FDA review panel - the closest regulatory comparables to K171247.
HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806
K925550 · Hichem Diagnostics · Apr 1993
LANCER BUN RATE REAGENT KIT
K812308 · Sherwood Medical Co. · Aug 1981
BUN REAGENT KIT #88108
K800616 · Hi Chem, Inc. · Apr 1980
BUN REAGENT KIT
K800071 · Fisher Scientific Co., LLC · Feb 1980
DIAG. CONDUCTA RATE BUN REAG. SET
K771060 · J.T. Baker Chemical Co. · Jul 1977
BLOOD-UREA-NITROGEN (BUN) ANALYZER 2
K761061 · Beckman Instruments, Inc. · Jan 1977