(810 days)
Not Found
No
The description focuses on standard in vitro diagnostic technologies (reflectance photometry, amperometric/electrochemical) and calculations based on pre-programmed calibration curves, with no mention of AI or ML.
No.
The device is an in vitro diagnostic system used for the quantitative determination of substances like cholesterol and glucose in whole blood, which are used in the diagnosis and treatment of conditions, but the device itself does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "This system is for in vitro diagnostic use only," and describes how the measurements are "used in the diagnosis and treatment of disorders."
No
The device description explicitly states that the system includes a "small analyzer and test strips," which are hardware components. The software is part of a larger hardware system used for in vitro diagnostic testing.
Based on the provided text, the device is explicitly stated to be an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for every variation of the system clearly states: "This system is for in vitro diagnostic use only."
- Device Description: The "Device Description" also refers to the analyzers as "in vitro diagnostic systems".
- Function: The device measures analytes (cholesterol, glucose, triglycerides, HDL) in whole blood, which is a biological sample taken from the body, for the purpose of diagnosis and treatment of various medical conditions. This aligns with the definition of an in vitro diagnostic device.
Therefore, there is no ambiguity; the device is an IVD.
N/A
Intended Use / Indications for Use
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.
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 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 Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides 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.
- Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.
A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus Analyzer.
The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels eGlu test strips) is for the quantitative determination of glucose in venous 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.
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 Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus 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 Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus 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 Plus Home analyzer.
The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus 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 Plus Home analyzer.
The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides 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.
- Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.
A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus Home Analyzer.
The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home eGlu test strips) is for the quantitative determination of 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.
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)
NBW, CGA, CHH, LBR, JGY
Device Description
- The CardioChek Plus and CardioChek Plus Home analyzers are professional (Rx) use (CardioChek Plus) and home use/OTC (CardioChek Plus Home) in vitro diagnostic systems to measure various analytes in capillary fingerstick whole blood for both home and professional use and in venous whole blood for professional use only for glucose, cholesterol, HDL cholesterol, and triglycerides.
- The system includes a small analyzer and test strips. The analyzers utilize PTS Diagnostics brands of dry strip chemistry test strips. The test strips are single-use and utilize one of two types of technologies: reflectance photometry and amperometric/electrochemical technology.
- The test strips are used with the CardioChek Plus and CardioChek Plus Home analyzers to measure total cholesterol, HDL cholesterol, triglycerides, and glucose in whole blood. The test strips utilize enzymatic methods on dry colorimetric test strips that are read by reflectance photometry or amperometric/electrochemical test strips that measure the current produced when blood is applied to the test strip. These test strips are for in vitro diagnostic use only.
- The analyzer has software that converts the reflectance or current produced into an analyte concentration by comparing the reading to a lot-specific calibration curve that is programmed into a EEPROM MEMo chip that is inserted into the analyzer. Each vial of test strips includes a lot-specific MEMo chip, thus eliminating any need for the user to calibrate the system.
- The analyzer is powered by 4 AA alkaline batteries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Venous whole blood and capillary whole blood from the fingertip.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional healthcare settings, single person for home use.
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)
Testing of the modified battery compartment of the case showed that the new design prevented the negative terminal of the battery contacting the positive terminal of the case when batteries are accidently inserted with the polarity reversed. The modification eliminated any potential concerns associated with incorrect insertion of the batteries.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
February 26, 2022
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics Margo Enright Director of Regulatory and Clinical Affairs 4600 Anson Boulevard Whitestown, Indiana 46075
Re: K193406
Trade/Device Name: CardioChek Plus Test System; CardioChek Plus Home Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, CHH, LBR, JGY Dated: October 15, 2020 Received: October 16, 2020
Dear Margo 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K193406
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
510(k) Number (if known) K193406
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known) K193406
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K193406
Device Name CardioChek Plus Test System
Indications for Use (Describe)
The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides 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.
· Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.
A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known) K193406
Device Name CardioChek Plus Test System
Indications for Use (Describe)
The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels eGlu test strips) is for the quantitative determination of glucose in venous 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.
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
510(k) Number (if known) K193406
Device Name CardioChek Plus Home Test System
Indications for Use (Describe)
The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
8
510(k) Number (if known) K193406
Device Name CardioChek Plus Home Test System
Indications for Use (Describe)
The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus 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 Plus 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
9
510(k) Number (if known) K193406
Device Name CardioChek Plus Home Test System
Indications for Use (Describe)
The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus 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 Plus 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
10
510(k) Number (if known) K193406
Device Name CardioChek Plus Home Test System
Indications for Use (Describe)
The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides 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.
· Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders.
A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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510(k) Number (if known) K193406
Device Name CardioChek Plus Home Test System
Indications for Use (Describe)
The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home eGlu test strips) is for the quantitative determination of 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.
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.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
12
SECTION 5: 510(k) SUMMARY- K193406
This summary of safety and effectiveness information is submitted in compliance with 21CFR 807.92.
January 24, 2022
1. Submitter Information/Facility Address:
Polymer Technology Systems, Inc. d/b/a PTS Diagnostics 4600 Anson Boulevard Whitestown, IN 46075
2. Contact Person: Margo Enright, RAC
Phone Number: 317-870-5610 x1012 email: menright@ptsdiagnostics.com
3. Trade Names/Models:
- CardioChek Plus Test System ●
- CardioChek Plus Home Test System ●
Components:
- CardioChek Plus analyzer
- CardioChek Plus Home analyzer
- · PTS Panels Lipid Panel test strips
- PTS Panels Chol+HDL+Glu test strips
- PTS Panels Chol+HDL test strips
- PTS Panels Chol+Glu test strips
- · PTS Panels eGlu test strips
- · CardioChek Plus Home Lipid Panel test strips
- CardioChek Plus Home Chol+HDL+Glu test strips
- · CardioChek Plus Home Chol+HDL test strips
- CardioChek Plus Home Chol+Glu test strips
- · CardioChek Plus Home eGlu test strips
4. Regulatory Information
| Product Codes: | NBW Glucose test system |
|---|---|
| CGA Glucose test system | |
| CHH Cholesterol (total) test system | |
| LBR Lipoprotein test system | |
| JGY Triglyceride test system |
Device Classification: Class II
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| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| CGA | Class II | 21 CFR 862.1345 | |
| Glucose test system | Chemistry | ||
| (75) | |||
| СНН | 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) | |||
| JGY | Class I, meets the | ||
| limitation of exemption 21 | |||
| CFR 862.9(c)(4) | 21 CFR 862.1705 | ||
| Triglyceride test system | Chemistry | ||
| (75) |
CardioChek Plus Test System
CardioChek Plus Home Test System
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NBW | |||
| 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) | |||
| JGY | Class I, meets the | ||
| limitation of exemption 21 | |||
| CFR 862.9(c)(4) | 21 CFR 862.1705 | ||
| Triglyceride test | |||
| system | Chemistry | ||
| (75) |
5. Device Description:
- The CardioChek Plus and CardioChek Plus Home analyzers are professional . (Rx) use (CardioChek Plus) and home use/OTC (CardioChek Plus Home) in vitro diagnostic systems to measure various analytes in capillary fingerstick whole blood for both home and professional use and in venous whole blood for professional use only for glucose, cholesterol, HDL cholesterol, and triglycerides.
- The system includes a small analyzer and test strips. The analyzers utilize PTS . Diagnostics brands of dry strip chemistry test strips. The test strips are singleuse and utilize one of two types of technologies: reflectance photometry and amperometric/electrochemical technology.
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- . The test strips are used with the CardioChek Plus and CardioChek Plus Home analyzers to measure total cholesterol, HDL cholesterol, triglycerides, and glucose in whole blood. The test strips utilize enzymatic methods on dry colorimetric test strips that are read by reflectance photometry or amperometric/electrochemical test strips that measure the current produced when blood is applied to the test strip. These test strips are for in vitro diagnostic use only.
- . The analyzer has software that converts the reflectance or current produced into an analyte concentration by comparing the reading to a lot-specific calibration curve that is programmed into a EEPROM MEMo chip that is inserted into the analyzer. Each vial of test strips includes a lot-specific MEMo chip, thus eliminating any need for the user to calibrate the system.
- The analyzer is powered by 4 AA alkaline batteries.
6. Intended Uses:
Lipid Panel Professional (Rx)
The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides 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.
· 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.
A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus Analyzer.
Chol+Glu+HDL Professional (Rx)
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 singleuse, auto-disabling lancing devices. This system is for in vitro diagnostic use only.
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· 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.
Chol+HDL Professional (Rx)
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, autodisabling 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.
Chol+Glu Professional (Rx)
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.
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eGlu Professional (Rx)
The CardioChek Plus Test System (consisting of the CardioChek Plus analyzer and PTS Panels eGlu test strips) is for the quantitative determination of 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.
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.
Lipid Panel Home (OTC)
The CardioChek Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home Lipid Panel test strips) is for the quantitative determination of total cholesterol, HDL (high density lipoprotein) cholesterol and triglycerides 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.
- 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.
A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Home Analyzer.
Chol+HDL+Glu Home (OTC)
The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus 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.
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A Chol/HDL ratio is calculated by the CardioChek Plus Home analyzer.
Chol+HDL Home (OTC)
The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus 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 Plus Home analyzer.
Chol+Glu Home (OTC)
The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus 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.
eGlu Home (OTC)
The CardioChek Plus Home Test System (consisting of the CardioChek Plus Home analyzer and CardioChek Plus Home eGlu test strips) is for the quantitative determination of 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.
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.
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7. Purpose of Submission
This 510(k) submission is for a modification of the CardioChek Plus Test System and CardioChek Home Test System, originally cleared May 22, 2015, under K140068. The modification for which this 510(k) is being submitted is a modification to the battery compartment of the analyzer case back. The CardioChek Plus/ Home test systems are the same as that described in the 510(k) Summary for K140068 and more recently cleared under K162282.
The modification is a redesign of the battery compartment in the back of the analyzer case. This modification prevents the negative terminal of the battery from contacting the positive terminal of the case when batteries are accidently inserted with the polarity reversed. This user error (reversed polarity) could result in the batteries overheating in the current design if replacement batteries from one manufacturer are incorrectly inserted. The modification prevents any battery overheating.
8. Predicate:
K140068 CardioChek Plus and CardioChek Home Test System
9. Reason for 510(k): Device Modification
The CardioChek Plus and CardioChek Plus Home test systems are modified to include a modification to the battery compartment of the analyzer case back. The modification is a design change that eliminates the potential for battery overheating if batteries are accidently inserted with the polarity reversed (incorrect insertion). Test strips used with these systems have been cleared under twenty-five 510(k)s since 1998, including most recently: K162282 and K151545.
Statement of Substantial Equivalence:
The modified CardioChek Plus and CardioChek Plus Home analyzers and modified CardioChek Plus System and CardioChek Plus Home System are modifications of the same devices as previously cleared and are substantially equivalent.
Predicate Device Information
| Predicate Name: | CardioChek Plus/CardioChek Home Test System |
|---|---|
| Device Company: | Polymer Technology Systems, Inc. d/b/a PTS |
| Diagnostics | |
| 510(k) Number: | K140068 |
This 510(k) submission is for a modification to devices that are FDA cleared under K140068 and the submitter (PTS) is the holder of the predicate 510(k).
The modified devices have the identical Intended Use/Indications for Use as the unmodified.
The fundamental scientific technology is identical.
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Modification to the predicate that is the basis for this 510(k):
Design change to the battery compartment in the back of the analyzer case to eliminate the possibility of contact of the negative terminal of the battery with the positive terminal of the analyzer case when batteries are accidently inserted incorrectly.
Comparison of Modified CardioChek Plus/CardioChek Plus Home to the CardioChek Plus/CardioChek Home- Similarities
| Description | Subject Device | Predicate Devices (K140068) |
|---|---|---|
| Indications for Use | Identical | See K140068 |
| Prescription/over- | ||
| the-counter use | Identical | Rx and OTC |
| Technology | Identical | Reflectance photometry and |
| amperometry |
Comparison of Modified CardioChek Plus/CardioChek Plus Home to the CardioChek Plus/CardioChek Home- Differences
| Description | Subject Device | Predicate Devices (K140068) |
|---|---|---|
| Battery | ||
| compartment of | ||
| analyzer case | New design prevents | |
| contact between | ||
| negative battery | ||
| terminal and positive | ||
| terminal of case. | ||
| Even if batteries are | ||
| installed incorrectly, | ||
| the modification to | ||
| the battery case | ||
| prevents any contact | ||
| between the negative | ||
| battery terminal and | ||
| the positive terminal | ||
| and the battery case, | ||
| thus preventing the | ||
| possibility of | ||
| overheating. | No issues with all AA batteries | |
| available when 510(k) cleared in |
Battery modification, by one battery
manufacturer, made it such that the
manufacturer's battery could allow
negative terminal of battery to contact
the positive terminal of the analyzer
case if replacement batteries are
installed incorrectly (polarity
reversed). This user error (installing
batteries incorrectly) could result in
overheating. |
Testing:
Testing of the modified battery compartment of the case showed that the new design prevented the negative terminal of the battery contacting the positive terminal of the case when batteries are accidently inserted with the polarity reversed. The modification eliminated any potential concerns associated with incorrect insertion of the batteries.
Conclusion:
The modified CardioChek Plus and CardioChek Plus Home test systems are safe and effective devices and substantially equivalent to the predicates.