Cleared Traditional

K914903 - QUICKSTART UREA NITROGEN

K914903 is an FDA 510(k) clearance for QUICKSTART UREA NITROGEN, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CDN cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K914903 · Em Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
60d
Days
Class 2
Risk

K914903 is an FDA 510(k) clearance for the QUICKSTART UREA NITROGEN. Classified as Urease, Photometric, Urea Nitrogen (product code CDN), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 31, 1991 after a review of 60 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K914903

510(k) Number K914903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1991
Decision Date December 31, 1991
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDN Device Classification - Class 2, Special Controls

Product Code CDN Urease, Photometric, 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 - CDN Urease, Photometric, Urea Nitrogen

All 15
Devices cleared under the same product code (CDN) and FDA review panel - the closest regulatory comparables to K914903.
EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
K961196 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996
BUN QVET
K943042 · Prisma Systems · Dec 1994
KING DIAGNOSTICS UREA NITROGEN REAGENT
K922969 · King Diagnostics, Inc. · Oct 1992
UREA NITROGEN (ENZYMATIC) DETERMINATION
K822154 · The Dow Chemical Co. · Aug 1982
BUN REAGENT ASTRA 4 & 8 ANALYZERS
K802518 · Nobel Scientific Industries, Inc. · Nov 1980
STATTEK BUN
K792328 · Boehringer Mannheim Corp. · Dec 1979