510(k) · Cleared
Recalled · Class II · 2013Bioscanner 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Systems, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Nov 20, 2001 as substantially equivalent to K982002 (Boehringer Mannheim Corp., 1998) after a 145-day review. Its family tree reaches back 2 generations to 1998. 5 later devices descend from it. It has been recalled once.
- Decided
- Nov 20, 2001
- Review
- 145 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K980731 (1998). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK980731 Accu-Chek Comfort Curve Test StripsBoehringer Mannheim Corp. · 1998
- 1 generation backK982002 Accu-Chek Comfort Curve Test StripBoehringer Mannheim Corp. · 1998 · Recalled
- This deviceK013068 Bioscanner 2000Polymer Technology Systems, Inc. · 2001
- 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 ownK070017 PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK041750 PTS Panels Chol+Glu Test PanelPolymer Technology Systems, Inc. · 2004 · Recalled
- 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
- K070017PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc. · 2007 · cites it directly1descendant
- K041750PTS Panels Chol+Glu Test PanelPolymer Technology Systems, Inc. · 2004 · 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 |
|---|---|---|---|---|---|
| −2 | K980731 | Accu-Chek Comfort Curve Test Strips | Boehringer Mannheim Corp. | 1998 | — |
| −1 | K982002 | Accu-Chek Comfort Curve Test Strip | Boehringer Mannheim Corp. | 1998 | 1 |
| 0 (this device) | K013068 | Bioscanner 2000 | Polymer Technology Systems, Inc. | 2001 | — |
| +1 | K071507 | PTS Panels Chol+HDL+Glu Panel Test Strips | Polymer Technology Systems, Inc. | 2007 | 4 |
| +1 | K070017 | PTS Panels Metabolic Chemistry Panel Test Strips | Polymer Technology Systems, Inc. | 2007 | — |
| +1 | K041750 | PTS Panels Chol+Glu Test Panel | Polymer Technology Systems, Inc. | 2004 | 1 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 2 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K982002 | Accu-Chek Comfort Curve Test StripSummary page 2…Test Strips are substantially equivalent to the predicate device noted below. Name: Accu-Chek Comfort Curve Test Strips Device Company: Roche Diagnostics 510(k) Number: K 982002 Similarities and Differences (Predicate and BioScanner Glucose) Similarities Both systems measure Glucose concentrations in bl… | 1998 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 4, 2013 | Class II | Z-1403-2013 | Under Investigation by firm | Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K071507 (Polymer Technology Systems, Inc., 2007) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K982002.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BioScanner Glucose Test Strips are intended to be used by healthcare professionals to measure glucose in whole blood and by individuals with diabetes to measure glucose in fingerstick whole blood at home. Glucose measurements are used in the management of carbohydrate metabolism disorders.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013068 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013068: Bioscanner 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013068
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026