510(k) · Cleared
ClearedTotal Bilirubin2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Ireland Diagnostics Division · CIG Diazo Colorimetry, Bilirubin
Cleared on Dec 29, 2022 as substantially equivalent to K121985 (Abbott Laboratories, 2013) after a 59-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Dec 29, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910591 (1991). No later device cites it as a predicate yet.
- Root · 3 generations backK910591 Roche Reagent for Total BilirubinRoche Diagnostic Systems, Inc. · 1991
- 2 generations backK060574 Total BilirubinAbbott Laboratories · 2006
- 1 generation backK121985 Architect Total BilirubinAbbott Laboratories · 2013
- This deviceK223324 Total Bilirubin2Abbott Ireland Diagnostics Division · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910591 | Roche Reagent for Total Bilirubin | Roche Diagnostic Systems, Inc. | 1991 | — |
| −2 | K060574 | Total Bilirubin | Abbott Laboratories | 2006 | — |
| −1 | K121985 | Architect Total Bilirubin | Abbott Laboratories | 2013 | — |
| 0 (this device) | K223324 | Total Bilirubin2 | Abbott Ireland Diagnostics Division | 2022 | — |
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 |
|---|---|---|---|
| * | K121985 | Architect Total BilirubinSummary page 5…al and unbound) in the neonate test system Governing Regulation Number: 21 CFR §862.1113 Product Code: MQM IV. Predicate Device ARCHITECT Total Bilirubin (k121985) V. Description of Device Principles of the Procedure Total (conjugated and unconjugated) bilirubin couples with… | 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 31 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K121985.
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Total Bilirubin2 assay is used for the quantitation of total bilirubin in human serum or plasma, of adults and neonates,
on the ARCHITECT c System.
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 disorders of the biliary tract. In newborn infants, the Total Bilirubin2 assay is intended to measure the levels
of total bilirubin (conjugated and unconjugated) in serum or plasma to aid in the diagnosis and management of neonatal
jaundice and hemolytic disease of the newborn.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223324 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223324: Total Bilirubin2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223324
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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