Cleared Traditional

K905602 - ECLIPSE ICA BUN

K905602 is an FDA 510(k) clearance for ECLIPSE ICA BUN, manufactured by Biotope, Inc.. The device is a Class 2 Chemistry device with product code CDQ cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K905602 · Biotope, Inc. · Chemistry device
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Jan 1991
Decision
34d
Days
Class 2
Risk

K905602 is an FDA 510(k) clearance for the ECLIPSE ICA BUN. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Biotope, Inc. (Redmond, US). The FDA issued a Cleared decision on January 16, 1991 after a review of 34 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 Biotope, Inc. devices

FDA 510(k) Submission Details - K905602

510(k) Number K905602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1990
Decision Date January 16, 1991
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDQ Device Classification - Class 2, Special Controls

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 108
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K905602.
OLYMPUS UREA NITROGEN (BUN) REAGENT
K922597 · Olympus Corp. · Jul 1992
IL TEST(TM) UREA NITROGEN
K914877 · Instrumentation Laboratory CO · Mar 1992
SYNERMED UREA NITROGEN REAGENT KIT
K911248 · Synermed, Inc. · Jun 1991
UREA NITROGEN TEST
K903334 · Em Diagnostic Systems, Inc. · Sep 1990
COULTER UREA NITROGEN REAGENT
K902175 · Coulter Corp. · Jun 1990
CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN
K901123 · Technicon Instruments Corp. · May 1990