Cleared Traditional

BUN-300/BUN-500 UREA NITROGEN REAGENT (K934533) - FDA 510(k) Clearance

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

K934533 · Horizon Diagnostics, Inc. · Chemistry device
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Nov 1993
Decision
70d
Days
Class 2
Risk

K934533 is an FDA 510(k) clearance for the BUN-300/BUN-500 UREA NITROGEN REAGENT. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Horizon Diagnostics, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on November 26, 1993 after a review of 70 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 Horizon Diagnostics, Inc. devices

Submission Details

510(k) Number K934533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1993
Decision Date November 26, 1993
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
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 116
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K932161 · Em Diagnostic Systems, Inc. · Sep 1993
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K925002 · Em Diagnostic Systems, Inc. · Jan 1993