510(k) · Cleared
ClearedAdvia Chemistry Microalbumin Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · JJW Urinalysis Controls (Assayed And Unassayed)
Cleared on Oct 3, 2005 as substantially equivalent to K043266 (Randox Laboratories, Ltd., 2005) after a 47-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Oct 3, 2005
- Review
- 47 days
- Class
- Class I
- Product code
- JJW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043266 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK043266 Randox Urine ControlsRandox Laboratories, Ltd. · 2005
- This deviceK052242 Advia Chemistry Microalbumin ControlsBayer Healthcare, LLC · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043266 | Randox Urine Controls | Randox Laboratories, Ltd. | 2005 | — |
| 0 (this device) | K052242 | Advia Chemistry Microalbumin Controls | Bayer Healthcare, LLC | 2005 | — |
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 JJW? 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 |
|---|---|---|---|
| * | K043266 | Randox Urine ControlsSummary page 2…AU2352, AU2353 Contract Manufacturinq Site: Randox Laboratories, Inc. 55 Diamond Road Crumlin, Antrim Country, UK 510(k) Number: K043266 4. Description of the device: The ADVIA® Chemistry Microalbumin Controls is a human urine based solution containing various con… | 2005 |
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.
How does its category compare?
All JJW devicesJJW Urinalysis Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJW
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJW
Too few JJW 510(k)s in any year since 2007 to give a median.
Recalls per year · JJW
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJW
1in 2022
MAUDE reports naming product code JJW, 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 | 2 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 7 | 1 |
| 2013 | 0 | — | 1 | 24 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 2 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of the ADVIA® Chemistry systems for the Microalbumin method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K052242: Advia Chemistry Microalbumin Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K052242
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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