510(k) · Cleared
ClearedDocument (TM) Multi-Analyte Linearity Test Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Casco Standards · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Feb 20, 1987 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Feb 20, 1987
- Review
- 30 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK870252 Document (TM) Multi-Analyte Linearity Test SetCasco Standards · 1987
- Descendant · cites it directly · 5 of its ownK012117 Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co. · 2001
- Descendant · 2 generations on · 3 of its ownK022401 PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK090405 Lipidpro SystemInfopia Co, Ltd. · 2009
- Descendant · 3 generations on · 0 of its ownK160282 SD LipidoCare Professional System, SD LipidoCare Home System, SD…Sd Biosensor · 2017
- Descendant · 4 generations on · 0 of its ownK130295 Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro…Infopia Co, Ltd. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K012117Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co. · 2001 · cites it directly5descendants
- K022401PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002 · 2 generations on3descendants
- K090405Lipidpro SystemInfopia Co, Ltd. · 2009 · 3 generations on1descendant
- K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor · 2017 · 3 generations on0descendants
- K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd. · 2013 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K870252 | Document (TM) Multi-Analyte Linearity Test Set | Casco Standards | 1987 | — |
| +1 | K012117 | Validate Chem 1 Calibration Verification Test Set, Model 10001 | Maine Standards Co. | 2001 | — |
| +2 | K022401 | PTS Panels Multi-Chemistry Controls | Polymer Technology Systems, Inc. | 2002 | — |
| +3 | K090405 | Lipidpro System | Infopia Co, Ltd. | 2009 | — |
| +3 | K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT… | Sd Biosensor | 2017 | — |
| +4 | K130295 | Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional… | Infopia Co, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
3 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?
- Of its descendants, K012117 (Maine Standards Co., 2001) has gone furthest, with 5 descendants 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 | — |
https://510kreport.com/device/K870252 · printed Nov 5, 2026
Cite this page
510(k) Report. “K870252: Document (TM) Multi-Analyte Linearity Test Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K870252
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026