PTS PANELS HDL Cholesterol Test Strips consist of chemical reagents in dry form. When whole blood is placed on the test strip, only the HDL cholesterol fraction passes through to the reaction layer. The HDL cholesterol reacts with a dried cholesterol reagent to produce color. The HDL concentration is proportional to the intensity of the color developed and is measured by a CardioChek brand analyzer.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and a study demonstrating the device meets those criteria. It is a 510(k) summary for the PTS PANELS HDL Cholesterol Test Strips, focusing on its substantial equivalence to predicate devices and its intended use.

However, I can extract information related to the device and its intended use based on the provided text.

Here's an analysis of what is and is not available in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Available: The document does not explicitly state acceptance criteria (e.g., specific accuracy, precision, or correlation thresholds) nor does it provide detailed performance data from a specific study against such criteria. The "Measuring Range" of 25-85 mg/dL HDL Cholesterol is mentioned, but this is a device specification, not an acceptance criterion related to a study outcome.

2. Sample Size Used for the Test Set and Data Provenance:

Not Available: The document does not describe any specific test set, its sample size, or its provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Available: Since no specific clinical or performance study is detailed, there's no mention of experts establishing ground truth or their qualifications.

4. Adjudication Method:

Not Available: No adjudication method is mentioned as there's no described study involving expert review.

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

Not Applicable/Not Available: This type of study is typically for image-based diagnostic aids involving human readers. The PTS PANELS HDL Cholesterol Test Strips are a dry chemistry test strip for quantitative measurement, not an imaging device requiring human interpretation in this context. Therefore, an MRMC study is not relevant, and no such study is described.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):

Partially Addressed by Nature of Device: The device itself is a standalone diagnostic tool, as it directly measures HDL cholesterol. However, the document does not describe a study explicitly proving its standalone performance against a defined set of acceptance criteria. The entire 510(k) submission process inherently evaluates the standalone performance of the device against predicate devices, but specific details of such a study (sample size, methods, results) are not in this summary.

7. Type of Ground Truth Used:

Implied (Not Explicitly Stated for a Study): For a device like this, the "ground truth" would typically be established by a reference laboratory method (e.g., a standardized enzymatic assay or a CDC-certified method) against which the device's measurements are compared. The document states the "Chemistry Method" is "Enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol," which suggests a well-established biochemical principle. However, it does not detail how this ground truth was applied in a specific performance study for the modified device.

8. Sample Size for the Training Set:

Not Available: The document does not describe any training set or its sample size. This device is a chemical assay, not an AI/ML algorithm that typically requires a training set in the conventional sense.

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

Not Applicable/Not Available: As no training set is described, there's no information on how its ground truth was established.

Summary of what is available from the document:

Device Name: PTS PANELS HDL Cholesterol Test Strips
Intended Use: To measure high density lipoprotein cholesterol in whole blood for the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases.
Technology: Dry chemistry test strip for use with PTS reflectance photometer.
Measuring Range: 25-85 mg/dL HDL Cholesterol.
Chemistry Method: Enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol.
Key Modification: Change in chemistry fractionation method from Phosphotungstic acid precipitation to Dextran sulfate inhibiting method, and removal of glass fiber from the blood separation membrane.
Predicate Devices: K990247 and K993377, the unmodified PTS PANELS HDL Cholesterol Test Strips from the same company.
Regulatory Class: Class I.

To answer the prompt fully, more detailed study reports (e.g., analytical and clinical validation studies) would be required, which are typically found in the full 510(k) submission, not just the summary provided here. The provided text is a summary focusing on substantial equivalence to predicate devices, not a detailed performance study report.

Summary

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K060617

APR 5 2006

SECTION F: 510(k) Summary

510(k) SUMMARY

This summary of safety and effectiveness information is submitted in compliance with 21CFR807.92.

1. Application Date:

March 6, 2006

2. Applicant Information:

Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268 Contact Person: Margo Enright Phone Number: 317-870-5610 FAX Number: 317-870-5608 e-mail: menright@cardiochek.com

3. Trade Names:

PTS PANELS HDL Cholesterol Test Strips

4. Description:

5. Classification Names:

Lipoprotein test system Panel: Clinical Chemistry 75 Product Codes: NAQ, LBR

6. Facility Address:

7736 Zionsville Road Indianapolis, IN 46268

7. Device Classification:

Class I (Regulations: 21 CFR 862.1175, 21 CFR 862.1475)

8. Intended Use:

PTS PANELS HDL Cholesterol Test Strips are intended to measure high density lipoprotein cholesterol in whole blood. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. ... .. .. ... ................................................................................................................................................................

9. Reason for 510(k):

Device Modification

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10. Predicate Device Information

The predicate devices for determination of substantial equivalence are: Name: PTS PANELS HDL Cholesterol Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K990247 and K993377

Similarities and Differences between modified PTS PANELS HDL Cholesterol Test Strips and the Predicate Device (unmodified)

Item	Predicates	Modified Device
Intended Use	Intended to measure HDL cholesterol in whole blood.	Same
Technology	Dry chemistry test strip for use with PTS reflectance photometer.	Same
Measuring Range	25-85 mg/dL HDL Cholesterol	Same
Product Storage	Store with vial tightly capped in a cool dry place at room temperature of 68-86°F.	Same
Specimen	Whole blood from fingerstick or venous blood collected in EDTA or heparin tube.	Same
Chemistry Method	Enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol.	Same
Calibration Curve	Resides on a read-only memory (EEPROM) chip packaged with the test strips.	Same
Differences Between Predicate and Modified Device
Item	Predicates	Modified Device
Chemistry Fractionation	Phosphotungstic acid precipitation method.	Dextran sulfate inhibiting method.
Blood	Contains glass fiber.	No glass fiber.

Similarities Between Predicate and Modified Device

1. Compliance with Special Controls
  Separation membrane Analyzer

Used on MTM BioScanner

(K972669)

Used on BioScanner

Plus (K013173 and K014099), which is

marketed as CardioChek and CardioChek PA.

. .

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The symbol is positioned inside a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference of the circle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

5 2006 APR

Ms. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

Re: K060617

Trade/Device Name: PTS PANELS HDL Cholesterol Test Strips Regulation Number: 21 CFR§862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I Product Code: NAQ, LBR Dated: March 6, 2006 Received: March 8, 2006

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Albert G. A.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: PTS PANELS HDL Cholesterol Test Strips

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson
__
Division Sign-Off

Division Sign-On

Office of In Vitro Diagnostic

Page 1 of

510(k) K040617

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.