510(k) · Cleared
Recalled · Class II · 2019PTS 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 Nov 15, 2002 as substantially equivalent to K990688 (Polymer Technology Systems, Inc., 1999) and 2 other predicates after a 23-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 15, 2002
- Review
- 23 days
- Class
- Class I
- Product code
- CHH
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K990688 (1999). 3 ancestors in all. 5 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK990688 MTM Bioscanner C Test StripsPolymer Technology Systems, Inc. · 1999 · Recalled
- This deviceK023558 PTS Panels Lipid Panel Test StripsPolymer 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 · cites it directly · 0 of its ownK151545 CardioChek Plus Test System, CardioChek Home Test System, CardioChek…Polymer Technology Systems, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK130295 Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro…Infopia Co, Ltd. · 2013
- Descendant · cites it directly · 0 of its ownK050182 Q.Steps Biometer G/C Dual Monitoring SystemBiomedix, Inc. · 2005
Most influential descendants
Showing 5 of 5 · 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
- K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…Polymer Technology Systems, Inc. · 2016 · cites it directly0descendants
- K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd. · 2013 · 2 generations on0descendants
- K050182Q.Steps Biometer G/C Dual Monitoring SystemBiomedix, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990688 | MTM Bioscanner C Test Strips | Polymer Technology Systems, Inc. | 1999 | 1 |
| 0 (this device) | K023558 | PTS Panels Lipid Panel Test Strips | 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 | — |
| +1 | K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test… | Polymer Technology Systems, Inc. | 2016 | 2 |
| +2 | K130295 | Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional… | Infopia Co, Ltd. | 2013 | — |
| +1 | K050182 | Q.Steps Biometer G/C Dual Monitoring System | Biomedix, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 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? (3)
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 |
|---|---|---|---|
| * | K990688 | MTM Bioscanner C Test StripsSummary page 2…LS) Cholesterol, HDL Cholesterol and Triglycerides Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K990688, K993377, KO00586 Similarities and Differences between PTS Lipid PANELS Test Strips and the Predi… | 1999 |
| * | K993377 | MTM Bioscanner HDL Test Strips, Over the Counter (Otc)Summary page 2…sterol, HDL Cholesterol and Triglycerides Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K990688, K993377, KO00586 Similarities and Differences between PTS Lipid PANELS Test Strips and the Predicate Devi… | 2000 |
| * | K000586 | Bioscanner Triglycerides Test Strips | 2000 |
What descends from it? (5)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2019 | Class II | Z-1372-2019 | Device Design | Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart… |
| 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?
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 test strips are intended to be used by healthcare professionals and individuals at home to measure three blood analytes: cholesterol, HDL cholesterol and triglycerides. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood…
Read the full statement (121 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 test strips are intended to be used by healthcare professionals and individuals at home to measure three blood analytes: cholesterol, HDL cholesterol and triglycerides. 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 di.orders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023558: 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/K023558
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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