510(k) · Cleared
ClearedDirect 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 Feb 16, 2016 as substantially equivalent to K053132 (Wako Chemicals USA, Inc., 2005) after a 181-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Feb 16, 2016
- Review
- 181 days
- Class
- Class II
- Product code
- JFM
- 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 deviceK152343 Direct BilirubinRandox Laboratories Limited · 2016
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) | K152343 | Direct Bilirubin | Randox Laboratories Limited | 2016 | — |
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 |
|---|---|---|---|
| * | K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791Summary page 4…Chemistry (75) 4. PREDICATE DEVICE PROPRIETARY NAMES AND 510(k) NUMBERS Predicate Device Proprietary Name: Wako Direct Bilirubin V 510(k) No.: K053132 Catalogue numbers: 02188390 & 02189494 1|Page 5. INTENDED USE The Direct Bilirub… | 2005 |
| † | K942458 | Precision-Multi-Sera - Human - Normal and Elevated | 1995 |
| † | K053153 | Randox Calibration Serum | 2006 |
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 25 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 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?
The Direct Bilirubin test system is a device intended for the quantitative in vitro determination of Direct Bilirubin in serum and plasma. Bilirubin measurements can be used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders including hepatitis and gall bladder block.
This device is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152343: Direct Bilirubin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152343
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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