Cleared Traditional

HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806 (K925550) - FDA 510(k) Clearance

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

K925550 · Hichem Diagnostics · Chemistry device
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Apr 1993
Decision
168d
Days
Class 2
Risk

K925550 is an FDA 510(k) clearance for the HI CHEM BUN REAGENT KIT,PRODUCT NUMBER 88806. Classified as Electrode, Ion Specific, Urea Nitrogen (product code CDS), Class II - Special Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on April 20, 1993 after a review of 168 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.

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Submission Details

510(k) Number K925550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1992
Decision Date April 20, 1993
Days to Decision 168 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 88d · This submission: 168d
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 K925550.
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