510(k) · Cleared
Recalled · Class II · 2022CardioChek Plus Test System, CardioChek Home Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Systems, Inc. D/B/A Pts Diagnostics · CGA Glucose Oxidase, Glucose
Cleared on Dec 22, 2016 as substantially equivalent to K071507 (Polymer Technology Systems, Inc., 2007) and 2 other predicates after a 129-day review. Its family tree reaches back 4 generations to 1998. It has been recalled 2 times.
- Decided
- Dec 22, 2016
- Review
- 129 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 4 generations to K980731 (1998). 12 ancestors in all, the oldest K972669 (1998). 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 backK041750 PTS Panels Chol+Glu Test PanelPolymer Technology Systems, Inc. · 2004 · Recalled
- This deviceK162282 CardioChek Plus Test System, CardioChek Home Test SystemPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2016
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 | K041750 | PTS Panels Chol+Glu Test Panel | Polymer Technology Systems, Inc. | 2004 | 1 |
| 0 (this device) | K162282 | CardioChek Plus Test System, CardioChek Home Test System | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 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? (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 |
|---|---|---|---|
| * | K071507 | PTS Panels Chol+HDL+Glu Panel Test StripsSummary page 13…Reason for Special 510(k): Device Modifications The CardioChek Plus Test System and the CardioChek Home Test System are modifications of the original devices (cleared in k071507, k071593 and k041750) to include the following: Wireless communications capability (professional system) Software soluti… | 2007 |
| * | K071593 | PTS Panels Chol+HDL Panel Test StripsSummary page 13…r Special 510(k): Device Modifications The CardioChek Plus Test System and the CardioChek Home Test System are modifications of the original devices (cleared in k071507, k071593 and k041750) to include the following: Wireless communications capability (professional system) Software solutions capab… | 2007 |
| * | K041750 | PTS Panels Chol+Glu Test PanelSummary page 13…0(k): Device Modifications The CardioChek Plus Test System and the CardioChek Home Test System are modifications of the original devices (cleared in k071507, k071593 and k041750) to include the following: Wireless communications capability (professional system) Software solutions capability Pr… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 16, 2022 | Class III | Z-1741-2022 | Labeling Change Control | Incorrect instructions for use were packaged into the final product. |
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 7 of the 12 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. 2016, 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 CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek Home Chol+HDL+Glu test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and glucose in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. Cholesterol measurements are used in the diagnosis and…
Read the full statement (781 words)
The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek Home Chol+HDL+Glu test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and glucose in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
HDL (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 in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
A Chol/HDL ratio is calculated by the CardioChek Home analyzer.
The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Chol+HDL+Glu test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and glucose in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
HDL (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 in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
A Chol/HDL ratio is calculated by the CardioChek Plus analyzer.
The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek Home Chol+HDL test strips) is for the quantitative determination of total cholesterol and HDL (high density lipoprotein) cholesterol in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
A Chol/HDL ratio is calculated by the CardioChek Home analyzer.
The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Chol+HDL test strips) is for the quantitative determination of total cholesterol and HDL (high density lipoprotein) cholesterol in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
A Chol/HDL ratio is calculated by the CardioChek Plus analyzer.
The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek Home Chol+Glu test strips) is for the quantitative determination of total cholesterol and glucose in capillary whole blood from the fingertip and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only.
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 diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Chol+Glu test strips) is for the quantitative determination of total cholesterol and glucose in venous whole blood and capillary whole blood from the fingertip and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only.
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 diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
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/K162282 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162282: CardioChek Plus Test System, CardioChek Home Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162282
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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