510(k) · Cleared
ClearedBioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System
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 Oct 2, 2014 as substantially equivalent to K071507 (Polymer Technology Systems, Inc., 2007) and 1 other predicate after a 45-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Oct 2, 2014
- Review
- 45 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K980731 (1998). 13 ancestors in all, the oldest K870012 (1987). No later device cites it as a predicate yet.
- Root · 4 generations backK980731 Accu-Chek Comfort Curve Test StripsBoehringer Mannheim Corp. · 1998
- 3 generations backK982002 Accu-Chek Comfort Curve Test StripBoehringer Mannheim Corp. · 1998 · Recalled
- 2 generations backK013068 Bioscanner 2000Polymer Technology Systems, Inc. · 2001 · Recalled
- 1 generation backK070017 PTS Panels Metabolic Chemistry Panel Test StripsPolymer Technology Systems, Inc. · 2007
- This deviceK142302 BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel…Polymer Technology Systems, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980731 | Accu-Chek Comfort Curve Test Strips | Boehringer Mannheim Corp. | 1998 | — |
| −3 | K982002 | Accu-Chek Comfort Curve Test Strip | Boehringer Mannheim Corp. | 1998 | 1 |
| −2 | K013068 | Bioscanner 2000 | Polymer Technology Systems, Inc. | 2001 | 1 |
| −1 | K070017 | PTS Panels Metabolic Chemistry Panel Test Strips | Polymer Technology Systems, Inc. | 2007 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K071507 | PTS Panels Chol+HDL+Glu Panel Test StripsSummary page 7…ips PTS PANELS Metabolic Chemistry Panel Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) number: k071507 and k070017 Comparison to Predicate: Each system is identical to the unmodified system with the exception of the addition… | 2007 |
| * | K070017 | PTS Panels Metabolic Chemistry Panel Test StripsSummary page 7…PTS PANELS Metabolic Chemistry Panel Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) number: k071507 and k070017 Comparison to Predicate: Each system is identical to the unmodified system with the exception of the addition of the ChekM… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- 5 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K071507.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians’ office and in acute and convalescent care facility bedside testing. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and of pancreatic islet cell…
Read the full statement (575 words)
The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians’ office and in acute and convalescent care facility bedside testing. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and of pancreatic islet cell carcinoma.
The Chol+Glu Test Panel system is intended to measure cholesterol and glucose in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals 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.
The Lipid Panel Test system is intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals to measure three blood analytes: cholesterol, HDL cholesterol and triglycerides. 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. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.
The PTS PANELS HDL Cholesterol Test system is 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.
The PTS PANELS CHOL+HDL Panel Test system is intended to be used by medical professionals 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.
The PTS PANELS CHOL+HDL+GLU Panel Test system is intended to be used by medical professionals 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.
The PTS PANELS Metabolic Chemistry Panel Test system is intended to be used by medical professionals to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. 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. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142302 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142302: BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142302
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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