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 Feb 27, 2026 as substantially equivalent to K131544 (Roche Diagnostics, 2013) after a 245-day review. Its family tree reaches back 4 generations to 1979.
- Decided
- Feb 27, 2026
- Review
- 245 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K781921 (1979). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK781921 Bilirubin, Dingle Valve DPDBoehringer Mannheim Corp. · 1979
- 3 generations backK981632 Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH · 1998
- 2 generations backK063543 Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total…Roche Diagnostics Corp. · 2006
- 1 generation backK131544 Cobas C Bilirubin Total Gen.3Roche Diagnostics · 2013 · Recalled
- This deviceK251998 Atellica CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K781921 | Bilirubin, Dingle Valve DPD | Boehringer Mannheim Corp. | 1979 | — |
| −3 | K981632 | Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent | Roche Diagnostics/Boehringer Mannheim GmbH | 1998 | — |
| −2 | K063543 | Cobas Integra Bilirubin Special and Roche/Hitachi Bilrubin Total, Models… | Roche Diagnostics Corp. | 2006 | — |
| −1 | K131544 | Cobas C Bilirubin Total Gen.3 | Roche Diagnostics | 2013 | 2 |
| 0 (this device) | K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | Siemens Healthcare Diagnostics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 K223078 Atellica® CH Diazo Direct Bilirubin (D_DBil)score 6.1 · 3 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 |
|---|---|---|---|
| * | K131544 | Cobas C Bilirubin Total Gen.3Summary page 5…Number: 21 CFR 862.1110, 21 CFR 862.1113 4. Predicate Device Information Predicate Device Name: Roche Cobas C Total Bilirubin Gen. 3 510(k) Number: K131544 Siemens Healthcare Diagnostics Inc. Atellica CH Diazo Total Bilirubin (D_TBil) Neonate Claim Traditional 510(k) Pre-Market No… | 2013 |
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 47 years and passes through 5 companies; a new generation was cleared every 12.6 years on median.
- 2 of the 5 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. 2026, 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 human serum and plasma of adults and
neonates 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 gallbladder block. A total bilirubin measurement in newborn infants is intended to aid in
indicating the risk of bilirubin encephalopathy (kernicterus).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251998 · printed Nov 3, 2026
Cite this page
510(k) Report. “K251998: Atellica CH Diazo Total Bilirubin (D_TBil).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K251998
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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