Cleared Traditional

K911248 - SYNERMED UREA NITROGEN REAGENT KIT

K911248 is the FDA 510(k) clearance for SYNERMED UREA NITROGEN REAGENT KIT by Synermed, Inc.. It is a Class 2 Chemistry device (product code CDQ) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K911248 · Synermed, Inc. · Chemistry device
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Jun 1991
Decision
74d
Days
Class 2
Risk

K911248 is an FDA 510(k) clearance for the SYNERMED UREA NITROGEN REAGENT KIT. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on June 3, 1991 after a review of 74 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 Synermed, Inc. devices

Submission Details

510(k) Number K911248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1991
Decision Date June 03, 1991
Days to Decision 74 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
14d faster than avg
Panel avg: 88d · This submission: 74d
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 87
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K911248.
MILES URINE UREA NITROGEN METHOD
K923035 · Heraeus Kulzer, Inc. · Sep 1992
OLYMPUS UREA NITROGEN (BUN) REAGENT
K922597 · Olympus Corp. · Jul 1992
IL TEST(TM) UREA NITROGEN
K914877 · Instrumentation Laboratory CO · Mar 1992
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