PTS PANELS CHOL+HDL Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol and high density lipoprotein cholesterol in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases.

Device Description

Dry chemistry test strip for use with PTS reflectance photometer. One test strip containing two tests.

AI/ML Overview

This document is a 510(k) summary for the PTS Panels CHOL+HDL Panel Test Strips. It focuses on the device modification and its substantial equivalence to previously cleared predicate devices. The provided text is a regulatory submission, not a detailed scientific study report. Therefore, much of the requested information regarding a "study that proves the device meets the acceptance criteria" in terms of rigorous clinical trial design (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance) is not present in the provided text.

Here's an analysis of the information that can be extracted, and where limitations exist:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of specific thresholds for accuracy, precision, or other performance metrics. Instead, it aims to demonstrate substantial equivalence to predicate devices. The "reported device performance" is essentially the claim that the new device performs "the same" as the predicate device regarding its intended use and chemical methods.

The key acceptance criterion implied by a 510(k) submission is that the modified device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and as effective. This is achieved by demonstrating that the modified device has the same intended use, technology, storage, specimen type, chemistry methods, and calibration curve as the predicate, with minor differences that do not raise new questions of safety or effectiveness.

The document highlights the following similarities and differences:

Item	Predicate	Modified Device
Intended Use	Intended to measure cholesterol and HDL cholesterol	Same
Technology	Dry chemistry test strip for use with PTS reflectance photometer.	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 an EDTA or heparin tube.	Same
Chemistry Methods	Cholesterol: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol.HDL: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol. Dextran Sulfate fractionation.	Same
Calibration Curve	Resides on a read-only memory (EEPROM) chip packaged with the test strips.	Same
Number of test strips to obtain results	Two	One test strip containing two tests.
Time to obtain results	About one minute for each test result.	About two minutes.

Conclusion regarding performance: The document implicitly argues that because the core technology, chemistry, and intended use are the same, the performance is also "the same" or substantially equivalent. The only reported performance difference is the time to obtain results (2 minutes for the new device vs. 1 minute per test for the old, but the new device combines both tests into one strip).

Study Information (Not Present in Detail)

The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence, not typically a detailed report of a new clinical study with specific acceptance criteria and performance data. Therefore, the following information is not available in the provided document:

Sample size used for the test set and the data provenance: Not mentioned. The 510(k) summary typically references studies conducted, but the details of those studies (like sample size or data origin) are usually found in the full 510(k) submission, not the summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a test strip for chemical analysis, not an AI-assisted diagnostic imaging device that involves human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an algorithm. This is a chemical test strip. Its "standalone" performance would be its analytical accuracy and precision, which are typically evaluated against a reference method. While such studies would have been performed for the original predicate devices and likely for the modified device to show equivalence, the details are not in this summary.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned explicitly. For chemical assays like this, the "ground truth" (or reference method) is typically a highly accurate laboratory method (e.g., a standardized enzymatic reference method run on a clinical chemistry analyzer).
The sample size for the training set: Not applicable for this type of device. There isn't an "algorithm" being trained in the conventional sense of machine learning. The "calibration curve" resides on an EEPROM chip, which is pre-programmed based on manufacturing data and chemical principles, not a "training set" of patient data.
How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided text is a regulatory submission demonstrating substantial equivalence for a modified medical device (test strips for cholesterol and HDL). It does not contain the detailed study results and specific acceptance criteria that would typically be found in a clinical performance study report for an AI-enabled device or a novel diagnostic. The "acceptance criteria" here are met by demonstrating that the new device is fundamentally the same as its cleared predecessors.

Summary

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K07/593

SECTION F: 510(k) Summary

CC7 1 5 2007

510(k) SUMMARY

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

1. Application Date: September 25, 2007
1. Applicant Information: Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

Contact Person: Margo Enright Phone Number: 317-870-5610 x1064 FAX Number: 317-870-5608 e-mail: menright@cardiochek.com

1. Trade Name: PTS PANELS CHOL+HDL Panel Test Strips
1. Classification Names: Cholesterol (total) test system and Lipoprotein (high density lipoprotein) test system. Panel: Clinical Chemistry 75 Product Codes: CHH, LBR
1. Establishment Registration Number: 1836132
ર્. Facility Address: 7736 Zionsville Road Indianapolis, IN 46268
1. Device Classification: Class 1 (Regulations: 21CFR 862.1175 and 862.1475)

8. Intended Use:

1. Reason for 510(k):
  Device Modification

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Predicate Device Information 10.

The predicate devices for determination of substantial equivalence are: Name: PTS PANELS Cholesterol Test Strips

PTS PANELS HDL Cholesterol Test Strips

Device Company: Polymer Technology Systems, Inc.

510(k) Numbers:

Cholesterol: K981493, K990688 HDL Cholesterol: K060617

Similarities and Differences between modified device (PTS PANELS CHOL+HDL Panel Test Strips) and the Predicate Device (unmodified- PTS PANELS Cholesterol and PTS PANELS HDL Cholesterol Test Strips)

Item	Predicate	Modified Device
Intended Use	Intended to measure cholesterol and HDL cholesterol	Same
Technology	Dry chemistry test strip for use with PTS reflectance photometer.	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 an EDTA or heparin tube.	Same
Chemistry Methods	Cholesterol: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol.HDL: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol. Dextran Sulfate fractionation.	Same
Calibration Curve	Resides on a read-only memory (EEPROM) chip packaged with the test strips.	Same

Similarities Between Predicate and Modified Device

Differences Between Predicate and Modified Device

Item	Predicates	Modified Device
Number oftest strips toobtain results	Two	One test stripcontaining twotests.
Time toobtain results	About one minute for each testresult.	About two minutes.

11. Compliance with Special Controls

Does not apply.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 5 2007

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

Re: K071593 Trade/Device Name: PTS Panel CHOL+HDL Panel Test Strips Regulation Number: 21 CFR $862.1175 Regulation Name: Cholesterol (total) test system. Regulatory Class: Class I Product Code: CHH, LBR Dated: September 25, 2007 Received: September 27, 2007

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. Ilsting 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 10gally marketed predicate device results in a classification for your device and thus, perroits 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) 276-0490. 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 tollifican mumber (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Séan M. Cooper, M.S., D.V.M. 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

K871593 510(k) Number (if known):

Device Name:__PTS PANELS CHOL+HDL Panel 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 C. Benson
on Sign-Off

Page 1 of

്ലേ of In Vitro Diagnostic Device luation and Safety

K 07/593

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.