The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek 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.

o 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 ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Home 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.

o 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 ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek Plus Analyzer.

The CardioChek PA Test System (consisting of the CardioChek PA 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 ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA Analyzer.

The CardioChek PA Home Test System (consisting of the CardioChek PA Home analyzer and CardioChek Home Livid 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 o 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 ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA Home Analyzer.

Device Description

The PTS Panels Lipid Panel test strips and the CardioChek Home Lipid Panel test strips are used with the CardioChek Plus, CardioChek PA, CardioChek Home and CardioChek PA Home analyzers to measure total cholesterol and triglycerides 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.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CardioChek Test Systems (CardioChek Plus, CardioChek Home, CardioChek PA, CardioChek PA Home) involve demonstrating accuracy and precision for HDL cholesterol measurements within a modified dynamic range of 20-120 mg/dL. The reported performance is based on comparison to a reference laboratory method (Roche Cobas Integra 400 plus) and precision studies.

Performance Metric	Acceptance Criteria (Implied by equivalence claim and historical device performance)	Reported Device Performance
Accuracy (Correlation to Reference Method)	High correlation (r ≥ 0.90 typically expected for clinical agreement, though not explicitly stated as a statistical threshold)	CardioChek Plus Home: y = 0.99x + 0.55, r = 0.98
		CardioChek Plus: y = 0.99x + 0.55, r = 0.98
		CardioChek PA: y = 0.93x + 0.98, r = 0.98
		CardioChek PA Home: y = 0.93x + 0.98, r = 0.98
Precision (Coefficient of Variation, CV%)	Generally, CV% values for clinical chemistry analytes are expected to be low, typically < 5-10% depending on the analyte and concentration level. No explicit numerical criteria are given in the document.	CardioChek PA HDL:
		Level 1 (38.3 mg/dL): CV = 4.3%
		Level 2 (62.4 mg/dL): CV = 3.6%
		Level 3 (106.0 mg/dL): CV = 4.0%
		CardioChek PA Home HDL:
		Level 1 (38.3 mg/dL): CV = 4.3%
		Level 2 (62.4 mg/dL): CV = 3.6%
		Level 3 (106.0 mg/dL): CV = 4.0%
		CardioChek Plus HDL:
		Level 1 (39.5 mg/dL): CV = 4.1%
		Level 2 (63.3 mg/dL): CV = 4.2%
		Level 3 (108.3 mg/dL): CV = 4.8%
		CardioChek Home HDL:
		Level 1 (39.5 mg/dL): CV = 4.1%
		Level 2 (63.3 mg/dL): CV = 4.2%
		Level 3 (108.3 mg/dL): CV = 4.8%
Measuring Range (Dynamic Range)	20-120 mg/dL HDL cholesterol	Demonstrated with samples in the range of 21 to 112 mg/dL HDL cholesterol (for accuracy study) and various levels within the range for precision.

2. Sample Size and Data Provenance for the Test Set

Accuracy Test Set:
- Sample Size: 80 samples for each analyzer type (CardioChek Plus Home, CardioChek Plus, CardioChek PA, CardioChek PA Home).
- Data Provenance: Not explicitly stated, but based on the nature of medical device studies for FDA submission, it would typically be prospective data collected for the purpose of the study. The country of origin is not specified, but the submission is to the U.S. FDA.
Precision Test Set:
- Sample Size: 80 observations for Level 1 and Level 2 for all analyzers, and 80 observations (CardioChek PA/PA Home) or 78 observations (CardioChek Plus/Home) for Level 3. These observations were obtained by "three operators tested three levels of whole blood samples on five analyzers... over three time periods."
- Data Provenance: Not explicitly stated, but likely prospective data collected in a controlled laboratory setting.

3. Number of Experts and Qualifications for Ground Truth for the Test Set

This relates to a diagnostic device for quantitative measurement, not an AI classification system requiring expert interpretation for ground truth.
For Accuracy: The ground truth for HDL cholesterol measurements was established using a Roche Cobas Integra 400 plus HDL Cholesterol instrument, which is a recognized reference method in clinical chemistry. This is a laboratory analyzer, not an expert panel.
For Precision: The "ground truth" is the mean value obtained from repeated measurements of the same whole blood samples.

4. Adjudication Method for the Test Set

Not applicable as this is a quantitative measurement device study, not an AI diagnostic study requiring human expert adjudication of interpretations. The "ground truth" is derived from a reference laboratory instrument.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a study for a quantitative measurement device (lipid panel test system), not an AI algorithm intended for interpretation by human readers. The context is not one of human-in-the-loop performance improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, the accuracy and precision studies performed can be considered standalone performance of the device (analyzer with test strips), as it evaluates the device's ability to accurately and precisely measure HDL cholesterol compared to a reference method, without human interpretation as part of the primary output.

7. Type of Ground Truth Used

Accuracy: The ground truth for the accuracy study was established using a reference laboratory instrument (Roche Cobas Integra 400 plus HDL Cholesterol). This is considered a highly reliable, objective, and standardized method for clinical chemistry analytes.
Precision: The ground truth for precision is the central tendency (mean) of repeated measurements of controlled samples.

8. Sample Size for the Training Set

This document describes performance testing for a medical device (CardioChek Test System) that determines quantitative values using enzymatic methods on dry strips read by reflectance photometry. It is a traditional in vitro diagnostic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense for model development. The device's calibration parameters are programmed into a lot-specific memory chip. Therefore, there is no "training set" in the context of machine learning model development. The calibration and manufacturing processes would involve internal quality control and standardization.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an AI/machine learning model, this question is not applicable. The device's operational parameters and calibration are established through manufacturing processes and validated through studies like those described (accuracy and precision).

Summary

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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. MARGO ENRIGHT DIRECTOR OF REGULATORY AND CLINICAL AFFAIRS 7736 ZIONSVILLE ROAD INDIANAPOLIS IN 46268

Re: K151545

Trade/Device Name: Cardiochek Plus Test System, Cardiochek Home Test System, Cardiochek PA Test System, Cardiochek PA Home Test System Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: I, meets the limitation of exemption 21 CFR 862.9(c)(4) Product Code: CHH, LBR, JGY Dated: July 27, 2016 Received: July 29, 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.

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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/ResourcesforYou/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

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K151545

Device Name CardioChek Home Test System

Indications for Use (Describe)

o 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 ration and estimated values for LDL (low density lipoprotein) cholesterol are 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)

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510(k) Number (if known) K151545

Device Name CardioChek Plus Test System

Indications for Use (Describe)

o 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 ration 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)

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)

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510(k) Number (if known) K151545

Device Name CardioChek PA Test System

Indications for Use (Describe)

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 ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA 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)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K151545

Device Name CardioChek PA Home Test System

Indications for Use (Describe)

Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol o 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 ration and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA 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)

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SECTION 5: 510(k) SUMMARY- K151545

This summary of safety and effectiveness information is submitted in compliance with 21CFR 807.92.

December 5, 2016

Submitter Information/Facility Address:

Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

Contact Person: Margo Enright,RAC Phone Number: 317-870-5610 x1012 Email: menright@ptsdiagnostics.com

3. Trade Names:

CardioChek Plus Test System

This includes:

CardioChek Plus analyzer
· PTS Panels Lipid Panel test strips

CardioChek Home Test System

This includes:

CardioChek Home analyzer
· CardioChek Home Lipid Panel test strips

CardioChek PA Test System

This includes:

· CardioChek PA analyzer
PTS Panels Lipid Panel test strips

CardioChek PA Home Test System

This includes:

· CardioChek PA Home analyzer
· CardioChek Home Lipid Panel test strips

4. Regulatory Information

ProductCode	Classification	Regulation Section	Panel
CHH	Class I, meets the limitation ofexemption 21 CFR 862.9(c)(4)	21 CFR 862.1175 Cholesterol(Total) test system	Chemistry (75)
LBR	Class I, meets the limitation ofexemption 21 CFR 862.9(c)(4)	21 CFR 862.1475 Lipoproteintest system	Chemistry (75)
JGY	Class I, meets the limitation ofexemption 21 CFR 862.9(c)(4)	21 CFR 862.1705 Triglyceridetest system	Chemistry (75)

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5. Device Description:

6. Intended Use:

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.

The CardioChek Home Test System (consisting of the CardioChek Home analyzer and CardioChek 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.

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The CardioChek PA Test System (consisting of the CardioChek PA 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 PA Analyzer.

The CardioChek PA Home Test System (consisting of the CardioChek PA Home analyzer and CardioChek 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 PA Home Analyzer.

7. Reason for Traditional 510(k):

Change in the measuring range (dynamic range) for the HDL cholesterol analyte of the Lipid Panel test strips to 20-120 mg/dL (0.52-3.11 mmol/L).

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8. STATEMENT OF SUBSTANTIAL EQUIVALENCE:

The Lipid Panel test strips will be marketed as PTS Panels Lipid Panel test strips and CardioChek Home Lipid Panel test strips. They are substantially equivalent to the currently marketed Lipid Panel test strips (predicate).

9. Predicate Device Information:

Predicate

Name: CardioChek Plus Test System and CardioChek Home Test System Device Company: Polymer Technology Systems, Inc. (PTS) 510(k) Number: K140068

Name: CardioChek Test System Device Company: Polymer Technology Systems, Inc. (PTS) 510(k) Number: K023558

10. Similarities and Differences (Lipid Panel current and Lipid Panelnew):

Similarities

The test strips are the same test strips currently marketed. ●
. The test strips are intended for both prescription and OTC use (professional and home use).
Both test strips require a lot specific memory chip for result calculation, which are ● included in the same package with the test strips
The measuring range for the total cholesterol is 100-400 mg/dL ●
. The measuring range for the triglycerides is 50-500 mg/dL

Difference

The only difference is in the measuring (dynamic) range for the HDL cholesterol. The HDL cholesterol measuring range is changed to 20-120 mg/dL HDL cholesterol. This is accomplished by programming the lot specific memory chip with calibration parameters for the modified range.

11. Summary of Performance Testing:

Accuracy

Results of an accuracy study comparing whole blood HDL cholesterol on PTS Panels/CardioChek Home Lipid Panel test strips on the CardioChek PA/CardioChek PA Home and the CardioChek Plus/CardioChek Home analyzers to the Roche Cobas Integra 400 plus HDL Cholesterol (reference) are summarized below.

Lipid Panel HDL Cholesterol vs. Reference by analyzer

CardioChek Plus Home	CardioChek Plus	CardioChek PA	CardioChek PA Home
n = 80 samples	n = 80 samples	n = 80 samples	n = 80 samples
y = 0.99x+0.55	y = 0.99x+0.55	y = 0.93x+0.98	y = 0.93x+0.98
r = 0.98	r = 0.98	r = 0.98	r = 0.98

Range of samples tested: 21 to 112 mg/dL HDL cholesterol

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Precision

HDL Cholesterol (Multiple operators, analyzers, time periods): Using a lot of Lipid Panel test strips with an extended HDL dynamic range, three operators tested three levels of whole blood samples on five analyzers (CardioChek PA/CardioChek PA Home and CardioChek Plus/ CardioChek Home) for HDL cholesterol over three time periods with the results that follow.

CardioChek PA HDL	Level 1	Level 2	Level 3
No. of Observations (n)	80	80	80
Mean (mg/dL)	38.3	62.4	106.0
Std. Deviation (mg/dL)	1.65	2.26	4.2
Coefficient of Variation (%)	4.3	3.6	4.0
CardioChek PA Home HDL	Level 1	Level 2	Level 3
No. of Observations (n)	80	80	80
Mean (mg/dL)	38.3	62.4	106.0
Std. Deviation (mg/dL)	1.65	2.26	4.2
Coefficient of Variation (%)	4.3	3.6	4.0
CardioChek Plus HDL	Level 1	Level 2	Level 3
No. of Observations (n)	80	80	78
Mean (mg/dL)	39.5	63.3	108.3
Std. Deviation (mg/dL)	1.63	2.66	5.24
Coefficient of Variation (%)	4.1	4.2	4.8
CardioChek Home HDL	Level 1	Level 2	Level 3
No. of Observations (n)	80	80	78
Mean (mg/dL)	39.5	63.3	108.3
Std. Deviation (mg/dL)	1.63	2.66	5.24
Coefficient of Variation (%)	4.1	4.2	4.8

12. Conclusion:

The modified measuring range claim for the PTS Panels Lipid Panel test strips/CardioChek Home Lipid Panel test strips for use on the CardioChek Home Test System, CardioChek Plus Test System, CardioChek PA Test System and CardioChek PA Home Test System provides a product that is as safe and effective as the predicate device (CardioChek Plus Test System and CardioChek Home Test System cleared under K140068 and CardioChek Test System cleared under K023358).

Regulation Number and Section

§ 862.1175 Cholesterol (total) test system.

(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.