510(k) · Cleared
ClearedCardioChek Plus 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 Jul 7, 2015 as substantially equivalent to K140068 (Polymer Technology Systems, Inc., 2015) after a 29-day review. Its family tree reaches back 5 generations to 1987.
- Decided
- Jul 7, 2015
- Review
- 29 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K870012 (1987). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK870012 Triglyceride (Gpo-Trinder) ReagentSigma Diagnostics, Inc. · 1987
- 4 generations backK991894 Bioscanner Triglycerides Test StripsPolymer Technology Systems, Inc. · 2000
- 3 generations backK013173 Bioscanner Plus; Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2001 · Recalled
- 2 generations backK014099 Bioscanner PlusPolymer Technology Systems, Inc. · 2001
- 1 generation backK140068 Cardiochek Plus Test System, Cardiochek Home Test SystemPolymer Technology Systems, Inc. · 2015 · Recalled
- This deviceK151530 CardioChek Plus Test SystemPolymer Technology Systems, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K870012 | Triglyceride (Gpo-Trinder) Reagent | Sigma Diagnostics, Inc. | 1987 | — |
| −4 | K991894 | Bioscanner Triglycerides Test Strips | Polymer Technology Systems, Inc. | 2000 | — |
| −3 | K013173 | Bioscanner Plus; Lipid Panel Test Strips | Polymer Technology Systems, Inc. | 2001 | 1 |
| −2 | K014099 | Bioscanner Plus | Polymer Technology Systems, Inc. | 2001 | — |
| −1 | K140068 | Cardiochek Plus Test System, Cardiochek Home Test System | Polymer Technology Systems, Inc. | 2015 | 4 |
| 0 (this device) | K151530 | CardioChek Plus Test System | Polymer Technology Systems, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K140068 | Cardiochek Plus Test System, Cardiochek Home Test SystemSummary page 5…Predicate Device Information Device Trade Name: CardioChek Plus Test System Device Company: Polymer Technology Systems, Inc. (PTS) 510(k) number: k140068 Comparison to Predicate: The modified system is identical to the unmodified system with the exception of the addition of… | 2015 |
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 28 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 5 of the 12 ancestors have a recall of any class.
- 4 other devices also cite its predicate K140068.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Plus Test System is a small portable analyzer and test strip system 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. The tests strips are for the quantitative determination of glucose, total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and…
Read the full statement (199 words)
The CardioChek Plus Test System is a small portable analyzer and test strip system 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. The tests strips are for the quantitative determination of glucose, total
cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides in venous whole blood and capillary whole blood
from the fingertip. A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol and non-HDL
cholesterol are calculated by the CardioChek Plus analyzer.
• 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.
• 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.
• 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 as stated in the FDA summary.
https://510kreport.com/device/K151530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151530: CardioChek Plus Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151530
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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