510(k) · Cleared
ClearedArchitect Total Bilirubin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CIG Diazo Colorimetry, Bilirubin
Cleared on Feb 1, 2013 as substantially equivalent to K060574 (Abbott Laboratories, 2006) after a 210-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Feb 1, 2013
- Review
- 210 days
- Class
- Class II
- Product code
- CIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910591 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK910591 Roche Reagent for Total BilirubinRoche Diagnostic Systems, Inc. · 1991
- 1 generation backK060574 Total BilirubinAbbott Laboratories · 2006
- This deviceK121985 Architect Total BilirubinAbbott Laboratories · 2013
- Descendant · cites it directly · 1 of its ownK150510 Total BilirubinAbbott Laboratories · 2015
- Descendant · cites it directly · 0 of its ownK223324 Total Bilirubin2Abbott Ireland Diagnostics Division · 2022
- Descendant · 2 generations on · 0 of its ownK170065 ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc. · 2017 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K150510Total BilirubinAbbott Laboratories · 2015 · cites it directly1descendant
- K223324Total Bilirubin2Abbott Ireland Diagnostics Division · 2022 · cites it directly0descendants
- K170065ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910591 | Roche Reagent for Total Bilirubin | Roche Diagnostic Systems, Inc. | 1991 | — |
| −1 | K060574 | Total Bilirubin | Abbott Laboratories | 2006 | — |
| 0 (this device) | K121985 | Architect Total Bilirubin | Abbott Laboratories | 2013 | — |
| +1 | K150510 | Total Bilirubin | Abbott Laboratories | 2015 | — |
| +1 | K223324 | Total Bilirubin2 | Abbott Ireland Diagnostics Division | 2022 | — |
| +2 | K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | Siemens Healthcare Diagnostics, Inc. | 2017 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K060574 | Total BilirubinSummary page 5…Substantial Equivalence: The modified ARCHITECT Total Bilirubin assay is substantially equivalent to the Abbott Total Bilirubin assay (K060574) on the ARCHITECT c8000 Analyzer. These assays yield substantially equivalent Performance Characteristics.… | 2006 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 2 companies; a new generation was cleared every 15.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K150510 (Abbott Laboratories, 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CIG devicesCIG Diazo Colorimetry, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ARCHITECT Total Bilirubin assay is used for the quantitation of total bilirubin in human serum or plasma on the ARCHITECT c8000 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 gall bladder block.
A bilirubin (total and unbound) in the neonate test system is a device intended to measure the levels of bilirubin (total and unbound) in the blood (serum) of newborn infants to aid in indicating the risk of bilirubin encephalopathy (kemicterus).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121985: Architect Total Bilirubin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121985
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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