510(k) · Cleared
ClearedDirect Bilirubin Liquicolor and Total Bilirubin Liquicolor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stanbio Laboratory · JFM Enzymatic Method, Bilirubin
Cleared on Jun 30, 2005 as substantially equivalent to K910593 (Roche Diagnostic Systems, Inc., 1991) and 1 other predicate after a 146-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jun 30, 2005
- Review
- 146 days
- Class
- Class II
- Product code
- JFM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910593 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK910593 Roche Reagent for Direct BilirubinRoche Diagnostic Systems, Inc. · 1991
- This deviceK050266 Direct Bilirubin Liquicolor and Total Bilirubin LiquicolorStanbio Laboratory · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910593 | Roche Reagent for Direct Bilirubin | Roche Diagnostic Systems, Inc. | 1991 | — |
| 0 (this device) | K050266 | Direct Bilirubin Liquicolor and Total Bilirubin Liquicolor | Stanbio Laboratory | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 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? (2)
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 |
|---|---|---|---|
| * | K910593 | Roche Reagent for Direct BilirubinSummary page 1…II Product Code: JFM Substantial Equivalence of Device This test is substantially equivalent to: Product Name: Direct Bilirubin; Roche, 510(k) K910593 Total Bilirubin: Roche, 5 10(k) K910591 Description of Device The Direct Bilirubin LiquiColor® test kit… | 1991 |
| * | K910591 | Roche Reagent for Total BilirubinSummary page 1…evice This test is substantially equivalent to: Product Name: Direct Bilirubin; Roche, 510(k) K910593 Total Bilirubin: Roche, 5 10(k) K910591 Description of Device The Direct Bilirubin LiquiColor® test kit is comprised of two reagents, Reagent I (RI) and Reagent 2. To ca… | 1991 |
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?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K910593.
How does its category compare?
All JFM devicesJFM Enzymatic Method, Bilirubin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Stanbio Direct Bilirubin LiquiColor® and Total Bilirubin LiquiColor® test systems are devices intended to measure the levels of bilirubin (direct and total) in serum and plasma. Measurements of the levels of bilirubin, and 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050266: Direct Bilirubin Liquicolor and Total Bilirubin Liquicolor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050266
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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