510(k) · Cleared
ClearedAtellica® CH Diazo Direct Bilirubin (D_DBil)
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 Jun 12, 2023 as substantially equivalent to K053132 (Wako Chemicals USA, Inc., 2005) after a 255-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jun 12, 2023
- Review
- 255 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K912024 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK912024 Automated Biochemical Analyzer (WAK0-20R & 30R)Wako Chemicals USA, Inc. · 1991
- 2 generations backK970986 Wako Direct Bilirubin VWako Chemicals USA, Inc. · 1997
- 1 generation backK053132 Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691…Wako Chemicals USA, Inc. · 2005 · Recalled
- This deviceK223078 Atellica® CH Diazo Direct Bilirubin (D_DBil)Siemens Healthcare Diagnostics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912024 | Automated Biochemical Analyzer (WAK0-20R & 30R) | Wako Chemicals USA, Inc. | 1991 | — |
| −2 | K970986 | Wako Direct Bilirubin V | Wako Chemicals USA, Inc. | 1997 | — |
| −1 | K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791 | Wako Chemicals USA, Inc. | 2005 | 2 |
| 0 (this device) | K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
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 |
|---|---|---|---|
| * | K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791Summary page 4…Code: CIG Regulation Number: 21 CFR 862.1110 4. Predicate Device Information Predicate Device Name: Wako Direct Bilirubin V 510(k) Number: K053132 Siemens Healthcare Diagnostics Inc. Atellica® CH Diazo Direct Bilirubin (D_DBil) assay Traditional 510(k) Pre-Market Notifica… | 2005 |
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 32 years and passes through 2 companies; a new generation was cleared every 8.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K053132.
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 Direct Bilirubin (D_DBil) assay is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma using the Atellica® CH Analyzer.
Measurement of direct 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/K223078 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223078: Atellica® CH Diazo Direct Bilirubin (D_DBil).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223078
Report an extraction error
Are you the manufacturer?
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