510(k) · Cleared
ClearedPTS Panels Multi-Chemistry Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Systems, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Aug 21, 2002 as substantially equivalent to K012117 (Maine Standards Co., 2001) and 1 other predicate after a 29-day review. Its family tree reaches back 2 generations to 1987. 3 later devices descend from it.
- Decided
- Aug 21, 2002
- Review
- 29 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K870252 (1987). 7 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK870252 Document (TM) Multi-Analyte Linearity Test SetCasco Standards · 1987
- 1 generation backK012117 Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co. · 2001
- This deviceK022401 PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK090405 Lipidpro SystemInfopia Co, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK160282 SD LipidoCare Professional System, SD LipidoCare Home System, SD…Sd Biosensor · 2017
- Descendant · 2 generations on · 0 of its ownK130295 Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro…Infopia Co, Ltd. · 2013
Most influential descendants
Showing 3 of 3 · See all- K090405Lipidpro SystemInfopia Co, Ltd. · 2009 · cites it directly1descendant
- K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor · 2017 · cites it directly0descendants
- K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K022401 | PTS Panels Multi-Chemistry Controls | Polymer Technology Systems, Inc. | 2002 | — |
| +1 | K090405 | Lipidpro System | Infopia Co, Ltd. | 2009 | — |
| +1 | K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT… | Sd Biosensor | 2017 | — |
| +2 | K130295 | Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional… | Infopia Co, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 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? (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.
What descends from it? (3)
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 15 years and passes through 3 companies; a new generation was cleared every 14.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K090405 (Infopia Co, Ltd., 2009) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K012117.
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?
The PTS PANELS .)fulti-Chemistry Controls are intended for use on the BioScanner 2000 and CardioChek brand instruments to estimate precision and to detect systematic analytical deviations that may anse from reagent or analytical instnunent variation and are intended for use by healthcare professionals in both physicians' oEces and in acute and convalescent care facility bedside testing as well as consumers at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022401 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022401: PTS Panels Multi-Chemistry Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022401
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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