Cleared Traditional

K190807 - VITROS XT Chemistry Products TBIL-ALKP Slides

K190807 is an FDA 510(k) clearance for VITROS XT Chemistry Products TBIL-ALKP ..., manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K190807 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
28d
Days
Class 2
Risk

K190807 is an FDA 510(k) clearance for the VITROS XT Chemistry Products TBIL-ALKP Slides. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on April 26, 2019 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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

FDA 510(k) Submission Details - K190807

510(k) Number K190807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2019
Decision Date April 26, 2019
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 213
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K190807.
Atellica® CH Diazo Direct Bilirubin (D_DBil)
K223078 · Siemens Healthcare Diagnostics, Inc. · Jun 2023
Atellica® CH Diazo Total Bilirubin (D_TBil)
K222104 · Siemens Healthcare Diagnostics, Inc. · Mar 2023
Total Bilirubin2
K223324 · Abbott Ireland Diagnostics Division · Dec 2022
ELITech Clinical Systems BILIRUBIN TOTAL 4+1, ELITech Clinical Systems BILIRUBIN DIRECT 4+1
K171401 · Elitechgroup · Jul 2017
Total Bilirubin
K150510 · Abbott Laboratories · Apr 2015
COBAS C BILIRUBIN TOTAL GEN.3
K131544 · Roche Diagnostics · Jul 2013