(126 days)
Not Found
No
The summary describes a dry chemistry test strip and reflectance photometer, which are standard laboratory technologies and do not mention any AI/ML components or capabilities.
No
The device is a diagnostic tool used to measure cholesterol levels, which aids in the diagnosis and treatment of disorders, but it does not directly treat or prevent a disease or condition itself.
Yes
The "Intended Use / Indications for Use" states that "Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders." and "Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases." which directly indicates its use for diagnosis.
No
The device description explicitly states it is a "Dry chemistry test strip for use with PTS reflectance photometer," indicating it is a hardware component (test strip) used with another hardware component (photometer).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the test strips are used to measure cholesterol and high density lipoprotein cholesterol in whole blood. This is a measurement performed in vitro (outside the body) on a biological sample (whole blood).
- Purpose of Measurement: The measurements are used in the "diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders," as well as "diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases." This clearly indicates a diagnostic purpose.
- Device Description: The description of a "Dry chemistry test strip for use with PTS reflectance photometer" further supports the idea of an in vitro test using a chemical reaction on a test strip to analyze a sample.
Therefore, based on the intended use and the nature of the device, it fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CHH, LBR
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and individuals in the home
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)
Not Found
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
§ 862.1175 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.
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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.
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- Application Date: September 25, 2007
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- 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
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- Trade Name: PTS PANELS CHOL+HDL Panel Test Strips
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- Classification Names: Cholesterol (total) test system and Lipoprotein (high density lipoprotein) test system. Panel: Clinical Chemistry 75 Product Codes: CHH, LBR
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- Establishment Registration Number: 1836132
- ર્. Facility Address: 7736 Zionsville Road Indianapolis, IN 46268
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- Device Classification: Class 1 (Regulations: 21CFR 862.1175 and 862.1475)
8. Intended Use:
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.
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- Reason for 510(k):
Device Modification
- Reason for 510(k):
대한민국 대학교 대학교 대학교 대학교 대학 대학교 대학교 대학교 대학교 대학교 대학 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 11 - 11 - 12 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 11 - 11 - 11 - 11 - 11 - 1
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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 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. |
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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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
4
Indications for Use
K871593 510(k) Number (if known):
Device Name:__PTS PANELS CHOL+HDL Panel Test Strips
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.
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
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്ലേ of In Vitro Diagnostic Device luation and Safety
K 07/593