Cleared Traditional

K190326 - VITROS XT Chemistry Products UREA-CREA ...

K190326 is the FDA 510(k) clearance for VITROS XT Chemistry Products UREA-CREA ... by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CDN) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K190326 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
29d
Days
Class 2
Risk

K190326 is an FDA 510(k) clearance for the VITROS XT Chemistry Products UREA-CREA Slides. Classified as Urease, Photometric, Urea Nitrogen (product code CDN), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on March 14, 2019 after a review of 29 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 Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K190326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2019
Decision Date March 14, 2019
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (CDN) and FDA review panel - the closest regulatory comparables to K190326.
VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K001885 · Ortho-Clinical Diagnostics, Inc. · Jul 2000
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QUICKSTART UREA NITROGEN
K914903 · Em Diagnostic Systems, Inc. · Dec 1991
STATTEK BUN
K792328 · Boehringer Mannheim Corp. · Dec 1979
BUN (UREASE) REAGENT
K781253 · Coulter Electronics, Inc. · Aug 1978
MULTISTAT III UREA NITROGEN TEST
K771442 · Instrumentation Laboratory CO · Aug 1977