(28 days)
Not Found
No
The device description and intended use describe a dry chemistry test strip and reflectance photometer, which are traditional laboratory technologies. There is no mention of AI, ML, image processing, or any other indicators of AI/ML technology.
No
The device is a diagnostic tool, measuring substances in blood for the diagnosis and management of diseases, rather than providing direct treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements (glucose, cholesterol, triglycerides) are "used in the diagnosis and treatment of disorders." This directly indicates a diagnostic purpose.
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), not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the test strips are used to measure substances (glucose, HDL cholesterol, and triglycerides) in a biological sample (fingerstick whole blood) to provide information for the diagnosis and treatment of various medical conditions. This is a core characteristic of IVDs.
- Device Description: The description of a "dry chemistry test strip for use with PTS reflectance photometer" further supports its function as a diagnostic tool that analyzes a sample outside of the body.
- Anatomical Site: The use of "Fingerstick whole blood" confirms that a biological sample is being collected and analyzed.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for clinical purposes.
N/A
Intended Use / Indications for Use
PTS PANELS Metabolic Chemistry Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, NAQ, NGO, CGA, JGY, LBR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
K013068, K060617, K991894, K000586
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).
Does not apply.
§ 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.
0
SECTION F: 510(k) Summary
510(k) SUMMARY
This summary of safety and effectiveness information is submitted in compliance with 21CFR807.92.
-
- Application Date: December 29, 2006
-
- 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 Name:
PTS PANELS Metabolic Chemistry Panel Test Strips
4. Classification Names:
Common Name(s): Glucose Test System, Lipoprotein and cholesterol (high density lipoprotein) test systems, Triglyceride Test System Panel: Clinical Chemistry 75 Product Codes: NBW, NAQ, NGO
Facility Address: న్.
7736 Zionsville Road Indianapolis, IN 46268
6. Device Classification:
Class 2 (Regulations: 21 CFR 862.1345, 862.1475, 862.1475, 862.1705)
7. Intended Use:
PTS PANELS Metabolic Chemistry Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. 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. 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.
8. Reason for 510(k):
Device Modification
9. Predicate Device Information
The predicate devices for determination of substantial equivalence are: Name: PTS PANELS Glucose, HDL Cholesterol and Triglycerides Test Strips
JAN 3 1 2007
1
Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: Glucose: K013068 HDL: K060617 Triglycerides: K991894 and K000586
Similarities and Differences between modified device (PTS PANELS Metabolic Chemistry Test Strips) and the Predicate Device (unmodified- PTS PANELS Glucose, HDL Cholesterol and Triglycerides Test Strips)
| Item | Predicates | Modified Device |
|---|---|---|
| Intended Use | Intended to measure glucose, HDL cholesterol and triglycerides 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 | Glucose: Colorimetric enzymatic (glucose oxidase) | |
| HDL: Colorimetric enzymatic (cholesterol esterase/oxidase) trinder method for cholesterol. | ||
| Triglycerides: Colorimetric enzymatic (cholesterol esterase/ glycerophosphate oxidase) | 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 | Three separate test strips | Single test strip with |
| three tests | ||
| Time to | ||
| obtain results | About one minute for each test. | About two minutes |
| for all three test | ||
| results. |
10. Compliance with Special Controls
Does not apply.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings and a base resembling a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Margo Enright Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268
JAN 3 1 2007
Re: K070017
Trade/Device Name: PTS Panels Metabolic Chemistry Panel Test Strips Regulation Number: 21 CFR § 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JGY, LBR, NAQ, NGO Dated: December 29, 2006 Received: January 03, 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, 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) 276-0490. 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 yours,
Jean m. Cooper, M.S., D.V.M.
Yean 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
K010017 510(k) Number (if known):
Device Name: PTS PANELS Metabolic Chemistry Panel Test Strips
PTS PANELS Metabolic Chemistry Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure glucose, high density lipoprotein cholesterol and triglycerides in fingerstick whole blood. Glucose measurements are used in the management of carbohydrate metabolism disorders. 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. 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.
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. Bonsem
Sign-Off
C frice of In Vitro Diagnostic Device Caluation and Safety
070017