510(k) · Cleared
ClearedAlbu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eurotrol B.V. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Mar 24, 2006 as substantially equivalent to K023928 (Medical Analysis Systems, Inc., 2002) after a 56-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Mar 24, 2006
- Review
- 56 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K023928 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK023928 Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed…Medical Analysis Systems, Inc. · 2002
- This deviceK060215 Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002Eurotrol B.V. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K023928 | Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis… | Medical Analysis Systems, Inc. | 2002 | — |
| 0 (this device) | K060215 | Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002 | Eurotrol B.V. | 2006 | — |
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 JJX? 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 |
|---|---|---|---|
| * | K023928 | Mas UA Control Liquid Assayed Urinalysis Control, Dade Assayed Urinalysis ControlSummary page 1…862.1660, Product Code JJX) Common Name: AlbuTrol Equivalent to: MAS® UA Control, 510(k) document control number K023928 Description AlbuTrol is an assayed urine albumin control material. AlbuTrol control material is filled of in dropper bottles. Ea… | 2002 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K023928.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
AlbuTrol is an assayed albumin control intended for professional use in the verification of the
precision and accuracy of the HemoCue® Urine Albumin and HemoCue® Albumin 201 systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060215 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060215: Albu Trol, Low, Model 108.001.002; Albu Trol, High 108.002.002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060215
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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