510(k) · Cleared
ClearedPTS Panels HDL Cholesterol Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Systems, Inc. · NAQ Lipoprotein, High Density, Hdl, Over The Counter
Cleared on Apr 5, 2006 as substantially equivalent to K990247 (Polymer Technology Systems, Inc., 1999) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.
- Decided
- Apr 5, 2006
- Review
- 28 days
- Class
- Class I
- Product code
- NAQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K990247 (1999). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK990247 MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470Polymer Technology Systems, Inc. · 1999
- This deviceK060617 PTS Panels HDL Cholesterol Test StripsPolymer Technology Systems, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK071507 PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc. · 2007 · Recalled
- Descendant · cites it directly · 1 of its ownK071593 PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc. · 2007 · Recalled
- 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 ownK162282 CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK142302 BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel…Polymer Technology Systems, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K071507PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc. · 2007 · cites it directly2descendants
- K071593PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc. · 2007 · cites it directly1descendant
- K070017PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc. · 2007 · cites it directly1descendant
- K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2016 · 2 generations on0descendants
- K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS…Polymer Technology Systems, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990247 | MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470 | Polymer Technology Systems, Inc. | 1999 | — |
| 0 (this device) | K060617 | PTS Panels HDL Cholesterol Test Strips | Polymer Technology Systems, Inc. | 2006 | — |
| +1 | K071507 | PTS Panels Chol+HDL+Glu Panel Test Strips | Polymer Technology Systems, Inc. | 2007 | 4 |
| +1 | K071593 | PTS Panels Chol+HDL Panel Test Strips | Polymer Technology Systems, Inc. | 2007 | 1 |
| +1 | K070017 | PTS Panels Metabolic Chemistry Panel Test Strips | Polymer Technology Systems, Inc. | 2007 | — |
| +2 | K162282 | CardioChek Plus Test System, CardioChek Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2016 | 2 |
| +2 | K142302 | BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System… | Polymer Technology Systems, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2014 | 1 | 0 |
| 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 NAQ? 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? (2)
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 |
|---|---|---|---|
| * | K990247 | MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470Summary page 2…equivalence are: Name: PTS PANELS HDL Cholesterol Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K990247 and K993377 Similarities and Differences between modified PTS PANELS HDL Cholesterol Test Strips a… | 1999 |
| * | K993377 | MTM Bioscanner HDL Test Strips, Over the Counter (Otc)Summary page 2…are: Name: PTS PANELS HDL Cholesterol Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K990247 and K993377 Similarities and Differences between modified PTS PANELS HDL Cholesterol Test Strips and the Predi… | 2000 |
What descends from it? (5)
3 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?
How does its category compare?
All NAQ devicesNAQ Lipoprotein, High Density, Hdl, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NAQ
FDA has decided no NAQ device since 2007.
Median 510(k) review, days · NAQ
Too few NAQ 510(k)s in any year since 2007 to give a median.
Recalls per year · NAQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NAQ
No MAUDE report names NAQ since 2007.
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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 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 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PTS PANELS HDL Cholesterol Test Strips are intended to measure high density lipoprotein cholesterol in whole blood. 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/K060617 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060617: PTS Panels HDL Cholesterol 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/K060617
Report an extraction error
Are you the manufacturer?
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