510(k) · Cleared
ClearedDirect LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL Cholesterol Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stanbio Laboratory · JIX Calibrator, Multi-Analyte Mixture
Cleared on Mar 12, 2004 as substantially equivalent to K012287 (Roche Diagnostics Corp., 2001) after a 172-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Mar 12, 2004
- Review
- 172 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974733 (1998). No later device cites it as a predicate yet.
- Root · 2 generations backK974733 Boehringer Mannheim Direct LDL - CholesterolBoehringer Mannheim Corp. · 1998 · Recalled
- 1 generation backK012287 Modification to: Cobas Integra LDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp. · 2001 · Recalled
- This deviceK032936 Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL…Stanbio Laboratory · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974733 | Boehringer Mannheim Direct LDL - Cholesterol | Boehringer Mannheim Corp. | 1998 | 1 |
| −1 | K012287 | Modification to: Cobas Integra LDL-Cholesterol Plus 2ND Generation | Roche Diagnostics Corp. | 2001 | 2 |
| 0 (this device) | K032936 | Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL Cholesterol… | Stanbio Laboratory | 2004 | — |
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 JIX? 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 |
|---|---|---|---|
| * | K012287 | Modification to: Cobas Integra LDL-Cholesterol Plus 2ND GenerationSummary page 1…Device The Direct LDL-Cholesterol Liquid Color® and Direct HDL/LDL-Cholesterol Calibrator system (Stanbio) is substantially equivalent to LDL Cholesterol Plus (K012287) calibrated with HDL/LDL Cholesterol Plus Calibrator (Roche). Description of )evice The device is a system using the re… | 2001 |
| * | — | HDL/LDL Cholesterol Plus Calibrator Named without a submission number |
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 6 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K012287.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Direct LDL Cholesterol LiquiColor® and Direct HDL/LDL Cholesterol Calibrator system is a testing device for the quantitative determination of low-density lipoprotein cholesterol (LDL-C) in serum or plasma.
LDL Cholesterol measurement aids the diagnosis and treatment of lipid and lipoprotein metabolism disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032936 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032936: Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL Cholesterol Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032936
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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