510(k) · Cleared
Recalled · 2009PTS Panels Lipid Panel Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Systems, Inc. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Sep 24, 2002 as substantially equivalent to K013173 (Polymer Technology Systems, Inc., 2001) after a 21-day review. Its family tree reaches back 3 generations to 1987. 7 later devices descend from it. It has been recalled once.
- Decided
- Sep 24, 2002
- Review
- 21 days
- Class
- Class I
- Product code
- CHH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K870012 (1987). 6 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK870012 Triglyceride (Gpo-Trinder) ReagentSigma Diagnostics, Inc. · 1987
- 2 generations backK991894 Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc. · 2000
- 1 generation backK013173 Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2001 · Recalled
- This deviceK022898 PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002
- Descendant · cites it directly · 6 of its ownK140068 Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK163406 Mission Cholesterol Monitoring System, Mission Cholesterol Pro…ACON Laboratories, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK201037 FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022
- Descendant · 2 generations on · 0 of its ownK193406 CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2022
- Descendant · 2 generations on · 0 of its ownK182781 PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2018 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K140068Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · cites it directly6descendants
- K163406Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemACON Laboratories, Inc. · 2017 · 2 generations on1descendant
- K201037FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022 · 3 generations on0descendants
- K193406CardioChek Plus Test System; CardioChek Plus Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2022 · 2 generations on0descendants
- K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K870012 | Triglyceride (Gpo-Trinder) Reagent | Sigma Diagnostics, Inc. | 1987 | — |
| −2 | K991894 | Bioscanner Triglycerides Test Strips | Polymer Technology Systems, Inc. | 2000 | — |
| −1 | K013173 | Bioscanner Plus; Lipid Panel Test Strips | Polymer Technology Systems, Inc. | 2001 | 1 |
| 0 (this device) | K022898 | PTS Panels Lipid Panel Test Strips | Polymer Technology Systems, Inc. | 2002 | — |
| +1 | K140068 | Cardiochek Plus Test System, Cardiochek Home Test System | Polymer Technology Systems, Inc. | 2015 | 4 |
| +2 | K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System | ACON Laboratories, Inc. | 2017 | — |
| +3 | K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System | Taidoc Technology Corporation | 2022 | — |
| +2 | K193406 | CardioChek Plus Test System; CardioChek Plus Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2022 | — |
| +2 | K182781 | PTS Professional Chemistry Kit | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 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 CHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K013173 | Bioscanner Plus; Lipid Panel Test Strips | 2001 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140068 | Cardiochek Plus Test System, Cardiochek Home Test System | 2015 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2009 | Not classified | Z-1136-2010 | Nonconforming Material/Component | Exhibits under-recovery of all analytes. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K140068 (Polymer Technology Systems, Inc., 2015) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K013173.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The BioScanner Plus (CardioChek brand) analyzer is intended to be used by healthcare professionals to measure blood analytes on a test strip. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein…
Read the full statement (118 words)
The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The BioScanner Plus (CardioChek brand) analyzer is intended to be used by healthcare professionals to measure blood analytes on a test strip. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022898 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022898: PTS Panels Lipid Panel 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/K022898
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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