510(k) · Cleared
ClearedAtellica® CH Diazo Total Bilirubin (D_TBil)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · CIG Diazo Colorimetry, Bilirubin
Cleared on Mar 20, 2023 as substantially equivalent to K060628 (Dade Behring, Inc., 2006) after a 245-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Mar 20, 2023
- Review
- 245 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861700 (1986). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK861700 Dimension (TM) Clinical Chemistry SystemE.I. Dupont DE Nemours & Co., Inc. · 1986 · Recalled
- 1 generation backK060628 Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi…Dade Behring, Inc. · 2006 · Recalled
- This deviceK222104 Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861700 | Dimension (TM) Clinical Chemistry System | E.I. Dupont DE Nemours & Co., Inc. | 1986 | 2 |
| −1 | K060628 | Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi Calibrator | Dade Behring, Inc. | 2006 | 1 |
| 0 (this device) | K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CIG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CIG device
- #1 K251998 Atellica CH Diazo Total Bilirubin (D_TBil)score 11.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060628 | Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi CalibratorSummary page 4…Regulation Number: 21 CFR 862.1110 4. Predicate Device Information Predicate Device Name: Dimension TBI Flex reagent cartridge 510(k) Number: K060628 Siemens Healthcare Diagnostics Inc. Atellica® CH Diazo Total Bilirubin (D_TBil) assay Traditional 510(k) Pre-Market Notificat… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 19.8 years on median.
- 3 of the 3 ancestors have a recall of any class.
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · CIG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CIG
64in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CIG
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIG
52in 2025
MAUDE reports naming product code CIG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 3 | 199 | 0 | 8 |
| 2009 | 2 | — | 3 | 3 |
| 2010 | 1 | — | 0 | 6 |
| 2011 | 2 | — | 0 | 38 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 5 | 64 | 3 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 1 | — | 1 | 25 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 22 |
| 2022 | 1 | — | 0 | 26 |
| 2023 | 2 | — | 0 | 34 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 52 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Atellica® CH Diazo Total Bilirubin (D_TBil) assay is for in vitro diagnostic use in the
quantitative determination of total bilirubin in adults and children (non-neonates) in human serum and
plasma using the Atellica® CH Analyzer. Measurement of total bilirubin, an organic compound formed
during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of
liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222104: Atellica® CH Diazo Total Bilirubin (D_TBil).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222104
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026