510(k) · Cleared
Recalled · Class II · 2023ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · JFM Enzymatic Method, Bilirubin
Cleared on Mar 9, 2017 as substantially equivalent to K150510 (Abbott Laboratories, 2015) after a 59-day review. Its family tree reaches back 4 generations to 1991. It has been recalled 2 times.
- Decided
- Mar 9, 2017
- Review
- 59 days
- Class
- Class II
- Product code
- JFM
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910591 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK910591 Roche Reagent for Total BilirubinRoche Diagnostic Systems, Inc. · 1991
- 3 generations backK060574 Total BilirubinAbbott Laboratories · 2006
- 2 generations backK121985 Architect Total BilirubinAbbott Laboratories · 2013
- 1 generation backK150510 Total BilirubinAbbott Laboratories · 2015
- This deviceK170065 ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)Siemens Healthcare Diagnostics, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910591 | Roche Reagent for Total Bilirubin | Roche Diagnostic Systems, Inc. | 1991 | — |
| −3 | K060574 | Total Bilirubin | Abbott Laboratories | 2006 | — |
| −2 | K121985 | Architect Total Bilirubin | Abbott Laboratories | 2013 | — |
| −1 | K150510 | Total Bilirubin | Abbott Laboratories | 2015 | — |
| 0 (this device) | K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | Siemens Healthcare Diagnostics, Inc. | 2017 | — |
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 JFM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K150510 | Total BilirubinSummary page 4…Panel: Clinical Chemistry 3. Predicate Device Product Name: Abbott Laboratories Total Bilirubin 510(k) Clearance K150510 Regulation Description: Bilirubin (total or direct) test system; Bilirubin (total and unbound)… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2023 | Class II | Z-2471-2023 | Under Investigation by firm | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿ CH Total Bilirubin_2 (TBil_2), Atellica¿CH LDL… |
| Feb 13, 2020 | Class II | Z-1539-2020 | Under Investigation by firm | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All JFM devicesJFM Enzymatic Method, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JFM
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JFM
Too few JFM 510(k)s in any year since 2007 to give a median.
Recalls per year · JFM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFM
1in 2025
MAUDE reports naming product code JFM, 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 | 8 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use in the quantitative determination of total bilirubin in serum and plasma of adults and neonates on the ADVIA® Chemistry systems. 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 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/K170065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170065: ADVIA® Chemistry Total Bilirubin_2 (TBIL_2).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170065
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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