510(k) · Cleared
Recalled · Class II · 2023Total Bilirubin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories Limited · JFM Enzymatic Method, Bilirubin
Cleared on Jan 28, 2016 as substantially equivalent to K063845 (Bayer Healthcare, LLC, 2007) after a 162-day review. Its family tree reaches back 2 generations to 1999. It has been recalled once.
- Decided
- Jan 28, 2016
- Review
- 162 days
- Class
- Class II
- Product code
- JFM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992399 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K063845 | Advia Chemistry Total Bilirubin_2Summary page 5…Y NAMES AND 510 (k) NUMBERS Predicate Device Proprietary Name: Siemens Healthcare Diagnostic Inc (formerly Bayer Healthcare), Total Bilirubin_2 reagent 510 (k) Number: K063845 5. INTENDED USE For the quantitative in vitro determination of Total Bilirubin in serum and plasma. Total Bilirubin measuremen… | 2007 |
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 |
|---|---|---|---|---|
| Oct 11, 2023 | Class II | Z-0501-2024 | Device Design | Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 8.2 years on median.
- None of the 2 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. 2016, 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 the quantitative in vitro determination of Total Bilirubin for serum and plasma. Total Bilirubin measurements are used in the diagnosis and treatment of hemolytic, biliary and liver disorders, including hepatitis and cirrhosis.
This in vitro diagnostic device is intended for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152344: 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/K152344
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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