510(k) · Cleared
Recalled · 2009PTS Panels Chol+HDL 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 Oct 15, 2007 as substantially equivalent to K981493 (Polymer Technology Systems, Inc., 1998) and 2 other predicates after a 126-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 15, 2007
- Review
- 126 days
- Class
- Class I
- Product code
- CHH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K990247 (1999). 5 ancestors in all, the oldest K981493 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK990247 MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470Polymer Technology Systems, Inc. · 1999
- 1 generation backK060617 PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc. · 2006
- This deviceK071593 PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK162282 CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990247 | MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470 | Polymer Technology Systems, Inc. | 1999 | — |
| −1 | K060617 | PTS Panels HDL Cholesterol Test Strips | Polymer Technology Systems, Inc. | 2006 | — |
| 0 (this device) | K071593 | PTS Panels Chol+HDL Panel Test Strips | Polymer Technology Systems, Inc. | 2007 | — |
| +1 | K162282 | CardioChek Plus Test System, CardioChek Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2016 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K981493 | MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220Summary page 2…PTS PANELS HDL Cholesterol Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: Cholesterol: K981493, K990688 IHDL Cholesterol: K060617 Similarities and Differences between modified device (PTS P… | 1998 |
| * | K990688 | MTM Bioscanner C Test StripsSummary page 2…PANELS HDL Cholesterol Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: Cholesterol: K981493, K990688 IHDL Cholesterol: K060617 Similarities and Differences between modified device (PTS PANELS… | 1999 |
| * | K060617 | PTS Panels HDL Cholesterol Test StripsSummary page 2…Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: Cholesterol: K981493, K990688 IHDL Cholesterol: K060617 Similarities and Differences between modified device (PTS PANELS CHOL+HDL Panel Test Strips) and the P… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162282 | CardioChek Plus Test System, CardioChek Home Test System | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2009 | Not classified | Z-0975-2010 | Process control | Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 6.9 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K162282 (Polymer Technology Systems, Inc. D/B/A Pts Diagnostics, 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K981493.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
PTS PANELS CHOL+HDL Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol and high density lipoprotein cholesterol in whole blood. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071593 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071593: PTS Panels Chol+HDL Panel Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071593
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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