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 Jan 25, 2011 as substantially equivalent to K012513 (Bio-Rad, 2001) and 1 other predicate after an 81-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jan 25, 2011
- Review
- 81 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K002460 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002460 Liquichek Lipids Control, Model 641, 642Bio-Rad · 2000
- 2 generations backK012513 Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2…Bio-Rad · 2001
- 1 generation backK082067 MSC Lipid ControlMaine Standards Co. · 2008
- This deviceK103271 MSC Lipid ControlMaine Standards Co. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002460 | Liquichek Lipids Control, Model 641, 642 | Bio-Rad | 2000 | — |
| −2 | 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 | — |
| 0 (this device) | K103271 | MSC Lipid Control | Maine Standards Co. | 2011 | — |
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? (2)
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…21 CFR 862.1660 Product Code: JJY -Regulatory Class: Class I Predicate Device: Bio-Rad LiquichekT m Lipids Control Leve! I and 2 (KO012513). MSC Lipid Control (without Apo Al and Apo B) (K082067) Device description: The MSC Lipid Control is a human serum based liq… | 2001 |
| * | K082067 | MSC Lipid ControlSummary page 1…-Regulatory Class: Class I Predicate Device: Bio-Rad LiquichekT m Lipids Control Leve! I and 2 (KO012513). MSC Lipid Control (without Apo Al and Apo B) (K082067) Device description: The MSC Lipid Control is a human serum based liquid quality control containing stabilized HDL-C, LDL-C,… | 2008 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
- 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. 2011, 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 quality control material to monitor the
ongoing precision of clinical laboratory systems for the following analytes: High-density
Lipoprotein Cholesterol (HDL-C), Low-density Lipoprotein Cholesterol (LDL-C), Total
Cholesterol (CHOL), Triglycerides (TRIG), Apolipoprotein A1 (Apo A1), and Apolipoprotein B
(Apo B), on instruments listed in the value sheet.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103271 · printed Nov 3, 2026
Cite this page
510(k) Report. “K103271: MSC Lipid Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K103271
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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