510(k) · Cleared
ClearedTriglyceride (Gpo-Trinder) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Diagnostics, Inc. · CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Cleared on Feb 20, 1987 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.
- Decided
- Feb 20, 1987
- Review
- 49 days
- Class
- Class I
- Product code
- CDT
- Recalls
- None
- Predicates
- 0
13 later devices descend from it, 1 citing it directly.
- This deviceK870012 Triglyceride (Gpo-Trinder) ReagentSigma Diagnostics, Inc. · 1987
- Descendant · cites it directly · 12 of its ownK991894 Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc. · 2000
- Descendant · 2 generations on · 9 of its ownK013173 Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2001 · Recalled
- Descendant · 3 generations on · 7 of its ownK022898 PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 7 of its ownK014099 Bioscanner PlusPolymer Technology Systems, Inc. · 2001
- Descendant · 4 generations on · 6 of its ownK140068 Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K991894Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc. · 2000 · cites it directly12descendants
- K013173Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2001 · 2 generations on9descendants
- K022898PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · 3 generations on7descendants
- K014099Bioscanner PlusPolymer Technology Systems, Inc. · 2001 · 3 generations on7descendants
- K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K870012 | Triglyceride (Gpo-Trinder) Reagent | Sigma Diagnostics, Inc. | 1987 | — |
| +1 | K991894 | Bioscanner Triglycerides Test Strips | Polymer Technology Systems, Inc. | 2000 | — |
| +2 | K013173 | Bioscanner Plus; Lipid Panel Test Strips | Polymer Technology Systems, Inc. | 2001 | 1 |
| +3 | K022898 | PTS Panels Lipid Panel Test Strips | Polymer Technology Systems, Inc. | 2002 | 1 |
| +3 | K014099 | Bioscanner Plus | Polymer Technology Systems, Inc. | 2001 | — |
| +4 | K140068 | Cardiochek Plus Test System, Cardiochek Home Test System | Polymer Technology Systems, Inc. | 2015 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 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 CDT? 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? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991894 | Bioscanner Triglycerides Test Strips | 2000 | 12 |
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, K991894 (Polymer Technology Systems, Inc., 2000) has gone furthest, with 12 descendants of its own.
How does its category compare?
All CDT devicesCDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDT
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · CDT
Too few CDT 510(k)s in any year since 2007 to give a median.
Recalls per year · CDT
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDT
12in 2025
MAUDE reports naming product code CDT, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 11 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 0 | — | 2 | 0 |
| 2015 | 1 | — | 0 | 6 |
| 2016 | 0 | — | 3 | 12 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K870012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K870012: Triglyceride (Gpo-Trinder) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K870012
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026