Cleared Traditional

BUN (KINETIC) (K895666) - FDA 510(k) Clearance

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

K895666 · Boehringer Mannheim Corp. · Chemistry device
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Oct 1989
Decision
37d
Days
Class 2
Risk

K895666 is an FDA 510(k) clearance for the BUN (KINETIC). Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 27, 1989 after a review of 37 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K895666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1989
Decision Date October 27, 1989
Days to Decision 37 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
51d faster than avg
Panel avg: 88d · This submission: 37d
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 37
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K895666.
IL TEST(TM) UREA NITROGEN
K914877 · Instrumentation Laboratory CO · Mar 1992
UREA NITROGEN TEST
K903334 · Em Diagnostic Systems, Inc. · Sep 1990
CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN
K901123 · Technicon Instruments Corp. · May 1990
UREA NITROGEN TEST (BUN) ITEM #65408
K894378 · Em Diagnostic Systems, Inc. · Aug 1989
UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
K884987 · Em Diagnostic Systems, Inc. · Jan 1989
BUN (KINETIC)
K881677 · Boehringer Mannheim Corp. · Jun 1988