(29 days)
No
The summary describes a portable analyzer and test strip system for quantitative determination of various analytes in blood. It mentions "result handling algorithms" and "system optics, calibration," but there is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The focus is on the analytical performance and stability of the test strips and analyzer.
No
The device is an in vitro diagnostic system used for quantitative determination of various substances in blood, which helps in diagnosis and monitoring, but it does not directly treat or restore health.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This system is for in vitro diagnostic use only." It also lists the quantitative determination of various substances (glucose, cholesterol, etc.) and their use in the diagnosis and treatment of various disorders.
No
The device description explicitly states it includes a portable analyzer (hardware) and test strips (consumables), in addition to software components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This system is for in vitro diagnostic use only."
- Nature of the Tests: The system performs quantitative determination of analytes (glucose, cholesterol, triglycerides) in biological samples (venous and capillary whole blood). This is a core characteristic of in vitro diagnostics, which are used to examine specimens taken from the human body.
- Purpose of the Measurements: The intended use describes how the measurements are used in the "diagnosis and treatment" of various diseases and disorders. This aligns with the definition of an IVD, which is used to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
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 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 mellius, 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.
Product codes (comma separated list FDA assigned to the subject device)
CGA, CHH, JGY, LBR, MRR
Device Description
The CardioChek Plus Test System includes the CardioChek Plus professional analyzer and analyte-specific test strips (PTS Panels eGLU test strips, PTS Panels Glucose test strips and PTS Panels Lipid Panel test strips). The CardioChek Plus Test System is modified in this submission by the addition of the CardioChek ChekMate strips. CardioChek ChekMate strips are dry strips that mimic the use of the PTS PANELS test strips to check the CardioChek analyzer system optics, calibration and result handling algorithms. ChekMate strips should not be used as a substitute for liquid quality control materials. There is no change to any of the test strips in any of the above named systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous whole blood, fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
CardioChek ChekMate Strips Precision: An Intermediate Precision evaluation was performed over a 20 day period as described in CLSI EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods. Three lots of ChekMate strips were evaluated on the CardioChek Plus using two (2) analyzers for each lot. Within run, between run, between day and total % CV for all results were less than 3.0%.
CardioChek ChekMate Strips Value Assignment: Previously reported in K142302
CardioChek ChekMate Strips Stability: Previously reported in K142302
Real-time Stability: The study supports an 18 month stability claim.
Re-use Stability: The study supports the claimed re-use stability of 500 uses for the ChekMate strips.
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.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2015
POLYMER TECHNOLOGY SYSTEMS, INC. MEGAN BURNS REGULATORY AFFAIRS ASSOCIATE 7736 ZIONSVILLE ROAD INDIANAPOLIS IN 46268
Re: K151530
Trade/Device Name: CardioChek Plus Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, CHH, JGY, LBR Dated: June 5, 2015 Received: June 8, 2015
Dear Ms. Megan Burns:
This letter corrects our substantially equivalent letter of July 7, 2015.
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
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
Courtney H. Lias -S
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
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Indications for Use
510(k) Number (if known) K151530
Device Name
CardioChek Plus Test System
Indications for Use (Describe)
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 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 mellius, 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.
| 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) |
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Section 5: 510(k) Summary
1. Applicant Information:
Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268
Contact Person: Megan A. Burns, RAC Phone: 317-870-5610 Fax: 317-870-5608
2. Date of Preparation:
July 2, 2015
3. Trade Name:
CardioChek Plus Test System
4. Device Description:
The CardioChek Plus Test System includes the CardioChek Plus professional analyzer and analyte-specific test strips (PTS Panels eGLU test strips, PTS Panels Glucose test strips and PTS Panels Lipid Panel test strips). The CardioChek Plus Test System is modified in this submission by the addition of the CardioChek ChekMate strips. CardioChek ChekMate strips are dry strips that mimic the use of the PTS PANELS test strips to check the CardioChek analyzer system optics, calibration and result handling algorithms. ChekMate strips should not be used as a substitute for liquid quality control materials. There is no change to any of the test strips in any of the above named systems.
5. Classification Names:
| Glucose Test System | |
|---|---|
| Panel: | Clinical Chemistry 75 |
| Product Codes: | CGA |
| Device Classification: | Class 2 |
| Regulation: | 21 CFR 862.1345 |
| Cholesterol Test System | |
| Panel: | Clinical Chemistry 75 |
| Product Codes: | CHH |
| Device Classification: | Class I [meets limitation of exemption as per 21 CFR 862.9(c)(4)] |
| Regulation: | 21 CFR 862.1175 |
| Triglyceride Test System | |
| Panel: | Clinical Chemistry 75 |
| Product Codes: | JGY |
| Device Classification: | Class I [meets limitation of exemption as per 21 CFR 862.9(c)(4)] |
| Regulation: | 21 CFR 862.1705 |
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| Lipoprotein Test System | |
|---|---|
| Panel: | Clinical Chemistry 75 |
| Product Codes: | LBR, MRR |
| Device Classification: | Class I [meets limitation of exemption as per 21 CFR 862.9(c)(4)] |
| Regulation: | 21 CFR 862.1475 |
6. Intended Use
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.
7. Reason for 510(k):
Device Modification
8. Predicate Device Information
Device Trade Name: CardioChek Plus Test System
Device Company: Polymer Technology Systems, Inc. (PTS)
K140068 510(k) number:
Comparison to Predicate:
The modified system is identical to the unmodified system with the exception of the addition of the CardioChek ChekMate strips.
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9. Performance Characteristics
The strips for each system are identical to the previously cleared strips. The CardioChek Plus Test System is unmodified compared to the predicate device with the exception of the addition of the CardioChek ChekMate strips.
CardioChek ChekMate Strips Precision:
An Intermediate Precision evaluation was performed over a 20 day period as described in CLSI EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods. Three lots of ChekMate strips were evaluated on the CardioChek Plus using two (2) analyzers for each lot. Within run, between run, between day and total % CV for all results were less than 3.0%.
CardioChek ChekMate Strips Value Assignment:
Previously reported in K142302
CardioChek ChekMate Strips Stability:
Previously reported in K142302
Real-time Stability:
The study supports an 18 month stability claim.
Re-use Stability:
The study supports the claimed re-use stability of 500 uses for the ChekMate strips.
10. Conclusion:
The performance characteristics above demonstrate that the modification of the above named test system by the addition of the CardioChek ChekMate strips is substantially equivalent to the unmodified system.