510(k) · Cleared
ClearedBioscanner Triglycerides Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Systems, Inc. · JGY Colorimetric Method, Triglycerides
Cleared on Jul 3, 2000 after a 132-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
- Jul 3, 2000
- Review
- 132 days
- Class
- Class I
- Product code
- JGY
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK000586 Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc. · 2000
- Descendant · cites it directly · 5 of its ownK023558 PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 1 of its ownK090405 Lipidpro SystemInfopia Co, Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK070017 PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK160282 SD LipidoCare Professional System, SD LipidoCare Home System, SD…Sd Biosensor · 2017
- Descendant · 2 generations on · 0 of its ownK151545 CardioChek Plus Test System, CardioChek Home Test System, CardioChek…Polymer Technology Systems, Inc. · 2016 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K023558PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · cites it directly5descendants
- K090405Lipidpro SystemInfopia Co, Ltd. · 2009 · 2 generations on1descendant
- K070017PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc. · 2007 · cites it directly1descendant
- K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor · 2017 · 2 generations on0descendants
- K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…Polymer Technology Systems, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000586 | Bioscanner Triglycerides Test Strips | Polymer Technology Systems, Inc. | 2000 | — |
| +1 | K023558 | PTS Panels Lipid Panel Test Strips | Polymer Technology Systems, Inc. | 2002 | 2 |
| +2 | K090405 | Lipidpro System | Infopia Co, Ltd. | 2009 | — |
| +1 | K070017 | PTS Panels Metabolic Chemistry Panel Test Strips | Polymer Technology Systems, Inc. | 2007 | — |
| +2 | K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT… | Sd Biosensor | 2017 | — |
| +2 | K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test… | Polymer Technology Systems, Inc. | 2016 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 JGY? 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)
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?
- Of its descendants, K023558 (Polymer Technology Systems, Inc., 2002) has gone furthest, with 5 descendants of its own.
How does its category compare?
All JGY devicesJGY Colorimetric Method, Triglycerides: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JGY
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JGY
Too few JGY 510(k)s in any year since 2007 to give a median.
Recalls per year · JGY
No recall names JGY since 2007.
Adverse event reports per year · JGY
1in 2021
MAUDE reports naming product code JGY, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K000586 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000586: Bioscanner Triglycerides Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000586
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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