510(k) · Cleared
ClearedLiquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641 and 642
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Aug 29, 2001 as substantially equivalent to K002460 (Bio-Rad, 2000) after a 23-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Aug 29, 2001
- Review
- 23 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002460 (2000). 4 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK002460 Liquichek Lipids Control, Model 641, 642Bio-Rad · 2000
- This deviceK012513 Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2…Bio-Rad · 2001
- Descendant · cites it directly · 1 of its ownK082067 MSC Lipid ControlMaine Standards Co. · 2008
- Descendant · cites it directly · 0 of its ownK103271 MSC Lipid ControlMaine Standards Co. · 2011
- Descendant · cites it directly · 0 of its ownK101226 Audit Microcv RF/CRP Linearity SetAalto Scientific, Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK042837 Liquichek Elevated CRP ControlBio-Rad · 2004
Most influential descendants
Showing 4 of 4 · See all- K082067MSC Lipid ControlMaine Standards Co. · 2008 · cites it directly1descendant
- K103271MSC Lipid ControlMaine Standards Co. · 2011 · cites it directly0descendants
- K101226Audit Microcv RF/CRP Linearity SetAalto Scientific, Ltd. · 2010 · cites it directly0descendants
- K042837Liquichek Elevated CRP ControlBio-Rad · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002460 | Liquichek Lipids Control, Model 641, 642 | Bio-Rad | 2000 | — |
| 0 (this device) | K012513 | Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641… | Bio-Rad | 2001 | — |
| +1 | K082067 | MSC Lipid Control | Maine Standards Co. | 2008 | — |
| +1 | K103271 | MSC Lipid Control | Maine Standards Co. | 2011 | — |
| +1 | K101226 | Audit Microcv RF/CRP Linearity Set | Aalto Scientific, Ltd. | 2010 | — |
| +1 | K042837 | Liquichek Elevated CRP Control | Bio-Rad | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K002460 | Liquichek Lipids Control, Model 641, 642Summary page 1…egulation Number: CFR 862.1660 3.0 Device to Which Substantial Equivalence is Claimed Liquichek™ Lipids Control Bio-Rad Laboratories Irvine, California Docket Number: K002460 4.0 Description of Device Liquichek™ Lipids Control is prepared from human serum with added constituents of human and animal or… | 2000 |
What descends from it? (4)
4 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?
- Its one ancestor has no recall.
- Of its descendants, K082067 (Maine Standards Co., 2008) has gone furthest, with 1 descendant of its own.
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.
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?
Assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012513: Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641 and 642.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012513
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026