Cleared Traditional

Atellica® CH Diazo Total Bilirubin (D_TBil) (K222104) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222104 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Mar 2023
Decision
245d
Days
Class 2
Risk

K222104 is an FDA 510(k) clearance for the Atellica® CH Diazo Total Bilirubin (D_TBil). Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on March 20, 2023 after a review of 245 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K222104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2022
Decision Date March 20, 2023
Days to Decision 245 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
157d slower than avg
Panel avg: 88d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 234
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K222104.
Atellica CH Diazo Total Bilirubin (D_TBil)
K251998 · Siemens Healthcare Diagnostics, Inc. · Feb 2026
Atellica® CH Diazo Direct Bilirubin (D_DBil)
K223078 · Siemens Healthcare Diagnostics, Inc. · Jun 2023
Total Bilirubin2
K223324 · Abbott Ireland Diagnostics Division · Dec 2022
VITROS XT Chemistry Products TBIL-ALKP Slides
K190807 · Ortho-Clinical Diagnostics, Inc. · Apr 2019
Total Bilirubin
K150510 · Abbott Laboratories · Apr 2015
ARCHITECT TOTAL BILIRUBIN
K121985 · Abbott Laboratories · Feb 2013