510(k) · Cleared
ClearedLiquichek Microalbumin Control Level 1, Level 2, Control Minipak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad, Diagnostics Grp. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Dec 11, 2007 as substantially equivalent to K020817 (Bio-Rad Laboratories, Inc., 2002) after a 69-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- Dec 11, 2007
- Review
- 69 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971954 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971954 Liquichek Urine Chemistry Control (Cat.NO. 397,398)Bio-Rad · 1997
- 1 generation backK020817 Liquichek Urine Chemistry ControlBio-Rad Laboratories, Inc. · 2002
- This deviceK072835 Liquichek Microalbumin Control Level 1, Level 2, Control MinipakBio-Rad, Diagnostics Grp. · 2007
- Descendant · cites it directly · 0 of its ownK133676 Abx Pentra Micro Alb Control L/HHoriba Abx Sas · 2014
- Descendant · cites it directly · 0 of its ownK121746 Randox Microalbumin Control Level 1 and Control Level 2 (Liquid)Randox Laboratories, Ltd. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971954 | Liquichek Urine Chemistry Control (Cat.NO. 397,398) | Bio-Rad | 1997 | — |
| −1 | K020817 | Liquichek Urine Chemistry Control | Bio-Rad Laboratories, Inc. | 2002 | — |
| 0 (this device) | K072835 | Liquichek Microalbumin Control Level 1, Level 2, Control Minipak | Bio-Rad, Diagnostics Grp. | 2007 | — |
| +1 | K133676 | Abx Pentra Micro Alb Control L/H | Horiba Abx Sas | 2014 | — |
| +1 | K121746 | Randox Microalbumin Control Level 1 and Control Level 2 (Liquid) | Randox Laboratories, Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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 JJY? 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 |
|---|---|---|---|
| * | K020817 | Liquichek Urine Chemistry ControlSummary page 1…Substantial Equivalence is Claimed Liquichek Urine Chemistry Control Bio-Rad Laboratories Irvine, California Docket Number: K020817 4.0 Description of Device Liquichek Microalbumin Control is prepared from human urine with added constituents o… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K133676 (Horiba Abx Sas, 2014) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K020817.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Liquichek Microalbumin Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072835: Liquichek Microalbumin Control Level 1, Level 2, Control Minipak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072835
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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