(129 days)
Not Found
No
The summary describes a device that uses enzymatic methods on a dry strip read by reflectance photometry to measure analytes. There is no mention of AI or ML in the intended use, device description, or performance studies. The calculation of a Chol/HDL ratio is a simple mathematical operation, not indicative of AI/ML.
No
This device is for in vitro diagnostic use, meaning it's used for diagnostic purposes outside the body, specifically to measure substances in blood to aid in diagnosis and treatment monitoring, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states "This system is for in vitro diagnostic use only" multiple times for all variations of the CardioChek Test Systems, and further specifies that the measurements are "used in the diagnosis and treatment of disorders."
No
The device description explicitly mentions "analyzers" (CardioChek Plus and CardioChek Home) and "test strips" which are hardware components used to perform the measurements. The software is part of a larger system that includes hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document repeatedly states "This system is for in vitro diagnostic use only." in the "Intended Use / Indications for Use" section for all variations of the CardioChek system.
- Device Description: The "Device Description" section also explicitly states that the test strips are "for in vitro diagnostic use only."
- Intended Use: The intended use is to quantitatively determine analytes (total cholesterol, HDL cholesterol, and glucose) in biological samples (capillary whole blood and venous whole blood) for the purpose of diagnosis and treatment of various medical conditions. This aligns directly with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW, CHH, LBR
Device Description
The PTS Panels Chol+HDL+Glu, Chol+HDL and Chol+Glu test strips and the CardioChek Home Chol+HDL+Glu, Chol+HDL and Chol+Glu test strips are used with the CardioChek Plus and CardioChek Home analyzers to measure total cholesterol, HDL cholesterol and glucose in whole blood. The test strips utilize enzymatic methods on a dry strip that is read by reflectance photometry. These test strips are for in vitro diagnostic use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home Test System: single person, not to be shared.
Plus Test System: multiple patient use in professional healthcare settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
As required by the risk analysis, all verification and validation activities were performed and the results demonstrated that the predetermined acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
POLYMER TECHNOLOGY SYSTEMS, INC. D/B/A PTS DIAGNOSTICS MARGO ENRIGHT DIRECTOR OF REGULATORY AND CLINICAL AFFAIRS 7736 ZIONSVILLE ROAD INDIANAPOLIS IN 46268
Re: K162282
Trade/Device Name: Cardiochek Plus Test System, Cardiochek Home Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA. NBW. CHH. LBR Dated: August 11, 2016 Received: August 15, 2016
Dear Ms. Enright:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kellie B. Kelm -S
for: Courtney H. Lias Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
Device Name CardioChek Home Test System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable) _ Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
510(k) Number (if known)
Device Name CardioChek Plus Test System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | ||||||
|---|---|---|---|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | X Prescription Use (Part 21 CFR 801 Subpart D) | X | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
| X Prescription Use (Part 21 CFR 801 Subpart D) | X | Prescription Use (Part 21 CFR 801 Subpart D) | ||||
| X | Prescription Use (Part 21 CFR 801 Subpart D) | |||||
| Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) | |||||
| Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
page 4
4
510(k) Number (if known)
Device Name CardioChek Home Test System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☐ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☑ | Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Page 5
5
510(k) Number (if known)
K162282
Device Name CardioChek Plus Test System
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Page 6
6
510(k) Number (if known)
Device Name CardioChek Home Test System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☐ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☑ Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
7
510(k) Number (if known)
K162282
Device Name CardioChek Plus Test System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
8
SECTION 5: 510(k) SUMMARY- K162282
This summary of safety and effectiveness information is submitted in compliance with 21CFR 807.92.
December 9. 2016
1. Submitter Information/FacilityAddress:
Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268
- Contact Person: MargoEnright, RAC Phone Number: 317-870-5610 x1012 email: menright@ptsdiagnostics.com
3. Trade Names:
- CardioChek Plus Test System
- CardioChek Home Test System
Components:
- CardioChek Plus analyzer
- CardioChek Home analyzer
- PTS Panels Chol+HDL+Glu test strips
- PTS Panels Chol+HDL test strips
- PTS Panels Chol+Glu test strips
- CardioChek Home Chol+HDL+Glu test strips
- CardioChek Home Chol+HDL test strips
- CardioChek Home Chol+Glu test strips
4. Regulatory Information
CardioChek Plus Test System
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| CGA | Class II | 21 CFR 862.1345 | |
| Glucose test system | Chemistry | ||
| (75) | |||
| CHH | Class I, meets the | ||
| limitation of exemption 21 | |||
| CFR 862.9(c)(4) | 21 CFR 862.1175 | ||
| Cholesterol (Total) | |||
| test system | Chemistry | ||
| (75) | |||
| LBR | Class I, meets the | ||
| limitation of exemption 21 | |||
| CFR 862.9(c)(4) | 21 CFR 862.1475 | ||
| Lipoprotein test | |||
| system | Chemistry | ||
| (75) |
9
CardioChek Plus Home Test System
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW | Class II | 21 CFR 862.1345 | |
| Glucose test system | Chemistry | ||
| (75) | |||
| CGA | Class II | 21 CFR 862.1345 | |
| Glucose test system | Chemistry | ||
| (75) | |||
| CHH | Class I, meets the | ||
| limitation of exemption 21 | |||
| CFR 862.9(c)(4) | 21 CFR 862.1175 | ||
| Cholesterol (Total) | |||
| test system | Chemistry | ||
| (75) | |||
| LBR | Class I, meets the | ||
| limitation of exemption 21 | |||
| CFR 862.9(c)(4) | 21 CFR 862.1475 | ||
| Lipoprotein test | |||
| system | Chemistry | ||
| (75) |
5. Device Description:
The PTS Panels Chol+HDL+Glu, Chol+HDL and Chol+Glu test strips and the CardioChek Home Chol+HDL+Glu, Chol+HDL and Chol+Glu test strips are used with the CardioChek Plus and CardioChek Home analyzers to measure total cholesterol, HDL cholesterol and glucose in whole blood. The test strips utilize enzymatic methods on a dry strip that is read by reflectance photometry. These test strips are for in vitro diagnostic use only.
6. Intended Use:
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.
10
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 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.
11
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.
12
7. Reason for Special510(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 ●
- Printer connectivity capability ●
- MEMo chip appearance ●
- Battery type
- Multiple language software capability
- Wired PC Communication ●
- Analyzer dimensions ●
The CardioChek Plus Test System and the CardioChek Home Test System include the PTS Panels test strips for use with the CardioChek Plus analyzer and the CardioChek Home test strips for use with the CardioChek Home analyzer. The test strips are unmodified from K041750, K071507 and K071593.
The three test strips are: Chol+HDL+Glu, Chol+HDL and Chol+Glu. The current trade names for each are:
- a. PTS Panels Chol+HDL+Glu test strips
- b. PTS Panels Chol+HDL test strips
- c. PTS Panels Chol+Glu test strips
- d. CardioChek Home Chol+HDL+Glu test strips
- e. CardioChek Home Chol+HDL test strips
- f. CardioChek Home Chol+Glu test strips
8. Statement of Substantial Equivalence
The CardioChek Plus Test System and CardioChek Home Test System are substantially equivalent to the predicates (K071507, K071593 and K041750).
9. Predicate Device Information
Predicates
Name: PTS Panels Chol+HDL+Glu Test Strips Device Company: Polymer Technology Systems, Inc. (PTS) 510(k) Number: K071507
Name: PTS Panels Chol+HDL Test Strips Device Company: Polymer Technology Systems, Inc. (PTS) 510(k) Number: K071593
13
Name: PTS Panels Chol+Glu Test Strips Device Company: Polymer Technology Systems, Inc. (PTS) 510(k) Number: K041750
10. Similarities and Differences
Similarities
- Both systems employ reflectance photometry. ●
- Both systems provide results that correlate to reference methods.
- Both test systems use the same test strips.
- Both systems require a lot specific memory chip for result calculation, which are included in ● the same package with the test strips
Differences
- The software for the CardioChek Plus and CardioChek Home analyzers have multiple . language options.
- The CardioChek Plus and CardioChek Home analyzers provide: ●
- Software solutions capability -
- Wired PC communication capability -
- Printer connectivity capability via a USB -
- Wireless communication capability (professional analyzer) -
- . The MEMo chip appearance is changed to make it more aesthetically pleasing. (The printed circuit board inside is the unmodified.)
- Analyzer outer case is larger. ●
- The modified analyzers use 4 AA batteries; the BioScanner Plus uses 2 AAA ● batteries.
11. Verification and Validation Summary
As required by the risk analysis, all verification and validation activities were performed and the results demonstrated that the predetermined acceptance criteria were met.
12. Conclusion
The intended use of the device is unchanged. The CardioChek Plus and CardioChek Home test systems are as safe and effective and perform as well as the predicate devices: K071507, K071593 and K041750.