(101 days)
PTS PANELS CHOL+HDL+GLU Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol, high density lipoprotein cholesterol and glucose 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. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.
Dry chemistry test strip for use with PTS reflectance photometer. Single test strip with three tests.
The provided text describes a 510(k) submission for the PTS PANELS CHOL+HDL+GLU Panel Test Strips, which are intended to measure cholesterol, HDL cholesterol, and glucose in whole blood. However, the document does not contain the acceptance criteria or a study that specifically proves the device meets those criteria.
The document primarily focuses on:
- 510(k) Summary: Basic regulatory information, applicant details, device classification, intended use, and reason for submission (device modification).
- Predicate Device Information: Comparison of the modified device with its predicate devices, highlighting similarities in intended use, technology, storage, specimen type, chemistry method, and calibration. The key difference noted is that the modified device combines three tests into a single strip with a slightly longer overall result time (about two minutes for all three tests, compared to about one minute for each of three separate tests in the predicate).
- FDA Premarket Notification Letter: Official communication from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
- Indications for Use: Detailed statement of how the device is intended to be used.
Based on the provided text, I cannot complete the requested information regarding acceptance criteria and the study that proves the device meets them, as this information is not present. The document states that the device is a modification of an existing device and that the FDA has determined it is substantially equivalent to legally marketed predicate devices. This suggests that the performance requirements might be similar to those of the predicate devices, but the specific acceptance criteria and the study design to demonstrate meeting them are not detailed here.
To answer your questions, I would need a different document, likely a "Performance Characteristics" or "Method Comparison Study" section, which is typically included in a 510(k) submission but is absent from the provided excerpt.
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SECTION F: 510(k) Summary
510(k) SUMMARY
This summary of safety and effectiveness information is submitted in compliance with 21CFR807.92.
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- Application Date: May 30, 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: e-mail: menright@cardiochek.com
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- Trade Name: PTS PANELS CHOL+HDL+GLU Panel Test Strips
4. Classification Names:
Lipoprotein and cholesterol (high density lipoprotein) test systems and Glucose Test System Panel: Clinical Chemistry 75 Product Codes: NBW, CHH, LBR
5. Facility Address:
7736 Zionsville Road Indianapolis, IN 46268
6. Device Classification:
Class 2 (Regulations: 21CFR 862.1345, 862.1175, 862.1475)
7. Intended Use:
PTS PANELS CHOL+HDL+GLU Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol. high density lipoprotein cholesterol and glucose 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. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.
8. Reason for 510(k):
Device Modification
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Predicate Device Information 9.
The predicate devices for determination of substantial equivalence are: Name: PTS PANELS Cholesterol, HDL Cholesterol and Glucose Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: Cholesterol: K981493, K990688 HDL: K060617 Glucose: K013068
Similarities and Differences between modified device (PTS PANELS CHOL+HDL+GLU Test Strips) and the Predicate Device (unmodified- PTS PANELS Cholesterol, HDL Cholesterol and Glucose Test Strips)
| Item | Predicates | Modified Device |
|---|---|---|
| Intended Use | Intended to measure cholesterol, HDL cholesterol and glucose in whole blood. | 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 Method | Cholesterol: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol.HDL: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol.Glucose: Colorimetric enzymatic (glucose oxidase) | Same |
| Calibration Curve | Resides on a read-only memory (EEPROM) chip packaged with the test strips. | Same |
| Item | Predicates | Modified Device |
| Number oftest strips toobtain results | Three separate test strips | Single test strip withthree tests |
| Time to | About one minute for each test. | About two minutes |
Similarities Between Predicate and Modified Device
for all three test
results.
Compliance with Special Controls 10.
obtain results
Does not apply.
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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 depiction of an eagle or bird-like figure with outstretched wings, positioned above three curved lines that resemble flowing fabric or water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Polymer Technology Systems, Inc. c/o Ms. Margo Enright Manager of Clinical Affairs 7736 Zionsville Road Indianapolis, IN 46268
Re: K071507
Trade/Device Name: PTS PANELS CHOL+HDL+GLU Panel Test Strips Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, CHH, LBR Dated: August 13, 2007 Received: August 14, 2007
SEP 1 0 2007
Dear Ms. Enright:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave ro rowed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrease of the enactment date of the Medical Device Amendments, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de Hoos mat have a ct (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 r ou may, arovisions 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 it may of casions 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, 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 toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Coopes, M.S., D.V.M.
Sean 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
510(k) Number (if known): K071507
Device Name: PTS PANELS CHOL+HDL+GLU Panel Test Strips
PTS PANELS CHOL+HDL+GLU Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol, high density lipoprotein cholesterol and glucose 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. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.
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
LAvision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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§ 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.