510(k) · Cleared
Recalled · Class II · 2018PTS Panels Chol+Glu Test Panel
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 Jul 23, 2004 as substantially equivalent to K972669 (Polymer Technology Systems, Inc., 1998) and 2 other predicates after a 24-day review. Its family tree reaches back 3 generations to 1998. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 23, 2004
- Review
- 24 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K980731 (1998). 5 ancestors in all, the oldest K972669 (1998). 1 later device descends from it, 1 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 deviceK041750 PTS Panels Chol+Glu Test PanelPolymer Technology Systems, Inc. · 2004
- 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 |
|---|---|---|---|---|---|
| −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) | K041750 | PTS Panels Chol+Glu Test Panel | Polymer Technology Systems, Inc. | 2004 | — |
| +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 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K972669 | MTM Bioscanner 1000 Test System Consisting of MTM Bioscanner 1000 Meter, MTM Bioscanner…Summary page 5…Name: BioScanner (PTS PANELS) Cholesterol and Glucose Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K972669, K981493, KO13068 Similarities and Differences between Chol+Gln Test Panel and the Predicate Devices:… | 1998 |
| * | K981493 | MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220Summary page 5…Name: BioScanner (PTS PANELS) Cholesterol and Glucose Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K972669, K981493, KO13068 Similarities and Differences between Chol+Gln Test Panel and the Predicate Devices:… | 1998 |
| * | K013068 | Bioscanner 2000 | 2001 |
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 |
|---|---|---|---|---|
| Mar 14, 2018 | Class II | Z-1543-2018 | Under Investigation by firm | Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 3 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.
- 2 other devices also cite its predicate K972669.
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.
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?
The Chol+Glu Test Panel is intended to measure cholesterol and glucose in whole blood on a BioScanner Plus (Cardidhek brand) analyzer. The test strips are intended to be used by healthcare professionals and individuals at home to measure blood cholesterol and glucose. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Glucose measurements are used in the management of carbohydrate metabolism disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041750 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041750: PTS Panels Chol+Glu Test Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041750
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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