510(k) · Cleared
ClearedMSC Lipid Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maine Standards Co. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Aug 22, 2008 as substantially equivalent to K012513 (Bio-Rad, 2001) after a 31-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Aug 22, 2008
- Review
- 31 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002460 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK002460 Liquichek Lipids Control, Model 641, 642Bio-Rad · 2000
- 1 generation backK012513 Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2…Bio-Rad · 2001
- This deviceK082067 MSC Lipid ControlMaine Standards Co. · 2008
- Descendant · cites it directly · 0 of its ownK103271 MSC Lipid ControlMaine Standards Co. · 2011
Most influential descendants
Showing 1 of 1 · See all- K103271MSC Lipid ControlMaine Standards Co. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002460 | Liquichek Lipids Control, Model 641, 642 | Bio-Rad | 2000 | — |
| −1 | K012513 | Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641… | Bio-Rad | 2001 | — |
| 0 (this device) | K082067 | MSC Lipid Control | Maine Standards Co. | 2008 | — |
| +1 | K103271 | MSC Lipid Control | Maine Standards Co. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K012513 | Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641 and 642Summary page 1…Number: 21 CFR 862.1660 Product Code: JJY Regulatory Class: Class I Predicate Device: Bio-Rad Liquichek TM Lipids Control Level 1 (K012513). Device description: The MSC Lipid Control is a human serum based liquid control containing stabilized Cholesterol, Triglycerid… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103271 | MSC Lipid Control | 2011 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K103271 (Maine Standards Co., 2011) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K012513.
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. 2008, 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?
The MSC Lipid Control is intended for use as an assayed control material to monitor the
ongoing precision of clinical laboratory analysis for Cholesterol, Triglycerides, HDL
Cholesterol, and LDL Cholesterol. This material is intended for use on automated,
semi-automated, and manual clinical chemistry analyzer systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082067 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082067: MSC Lipid Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082067
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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