510(k) · Cleared
Recalled · Class II · 2019PTS Panels Chol+HDL+Glu Panel Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Systems, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Sep 10, 2007 as substantially equivalent to K981493 (Polymer Technology Systems, Inc., 1998) and 3 other predicates after a 101-day review. Its family tree reaches back 3 generations to 1998. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 10, 2007
- Review
- 101 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 3 generations to K980731 (1998). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK980731 Accu-Chek Comfort Curve Test StripsBoehringer Mannheim Corp. · 1998
- 2 generations backK982002 Accu-Chek Comfort Curve Test StripBoehringer Mannheim Corp. · 1998 · Recalled
- 1 generation backK013068 Bioscanner 2000Polymer Technology Systems, Inc. · 2001 · Recalled
- This deviceK071507 PTS Panels Chol+HDL+Glu 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
- Descendant · cites it directly · 0 of its ownK142302 BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel…Polymer Technology Systems, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See all- K162282CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2016 · cites it directly0descendants
- K142302BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS…Polymer Technology Systems, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980731 | Accu-Chek Comfort Curve Test Strips | Boehringer Mannheim Corp. | 1998 | — |
| −2 | K982002 | Accu-Chek Comfort Curve Test Strip | Boehringer Mannheim Corp. | 1998 | 1 |
| −1 | K013068 | Bioscanner 2000 | Polymer Technology Systems, Inc. | 2001 | 1 |
| 0 (this device) | K071507 | PTS Panels Chol+HDL+Glu 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 |
| +1 | 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 |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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…lesterol, HDL Cholesterol and Glucose Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: Cholesterol: K981493, K990688 HDL: K060617 Glucose: K013068 Similarities and Differences between modified device… | 1998 |
| * | K990688 | MTM Bioscanner C Test StripsSummary page 2…HDL Cholesterol and Glucose Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: Cholesterol: K981493, K990688 HDL: K060617 Glucose: K013068 Similarities and Differences between modified device (PTS PANE… | 1999 |
| * | K060617 | PTS Panels HDL Cholesterol Test StripsSummary page 2…e Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: Cholesterol: K981493, K990688 HDL: K060617 Glucose: K013068 Similarities and Differences between modified device (PTS PANELS CHOL+HDL+GLU Test… | 2006 |
| * | K013068 | Bioscanner 2000Summary page 2…ce Company: Polymer Technology Systems, Inc. 510(k) Numbers: Cholesterol: K981493, K990688 HDL: K060617 Glucose: K013068 Similarities and Differences between modified device (PTS PANELS CHOL+HDL+GLU Test Strips) and the Predicate Devic… | 2001 |
What descends from it? (2)
2 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-1373-2019 | 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 displayed |
| Mar 15, 2016 | Class II | Z-0741-2020 | Storage | This lot of test strips is showing an under-recovery when tested against a reference method. |
| Jul 6, 2010 | Not classified | Z-2641-2010 | Other | The test strips appear to under-recover Cholesterol, HDL and glucose. |
| Aug 4, 2009 | Not classified | Z-1012-2010 | Other | Possible under recovery of cholesterol, HDL and glucose. A loss of recoverable cholesterol and HDL cholesterol is a manageable to moderate health risk. The clinical applications analysis shows that lot 1891 shows such a loss of activity.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 4 of the 8 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 NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
PTS PANELS CHOL+HDL+GLU Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol, high density lipoprotein cholesterol and glucose 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…
Read the full statement (101 words)
PTS PANELS CHOL+HDL+GLU Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol, high density lipoprotein cholesterol and glucose 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. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071507: PTS Panels Chol+HDL+Glu 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/K071507
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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