(356 days)
Not Found
No
The description focuses on a chemical reaction for measuring triglycerides and does not mention any AI or ML components.
No
The device is described as test strips for measuring triglyceride levels, which aids in diagnosis and treatment, but does not directly provide therapy. It is an in vitro diagnostic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test strips are used "as an aid in the diagnosis and treatment of patients."
No
The device description clearly describes a chemical reaction involving test strips and reagents, indicating a hardware component (the test strips and likely a reader) is necessary for the intended use.
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 triglyceride in whole blood as an aid in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, or various endocrine disorders." This clearly indicates the device is used to analyze a biological sample (whole blood) to provide information for medical diagnosis and treatment.
- Device Description: The description details a chemical reaction that occurs with the blood sample to produce a measurable result (formation of a quinoneimine dye). This is characteristic of in vitro diagnostic tests.
- Predicate Device: The mention of a predicate device (K870012; Triglyceride (GPO-Trinder) Reagent) which is also a triglyceride reagent, further supports that this device falls within the category of IVDs.
In summary, the device analyzes a biological sample (whole blood) outside of the body to provide information for medical purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioScanner Triglycerides test strips are intended to measure triglyceride in whole blood as an aid in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, or various endocrine disorders.
Product codes
CDT, JGY
Device Description
Triglycerides are hydrolyzed by lipoprotein lipase to glycerol and fatty acid. Glycerol is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP) forming glycerol-3-phosphate and adenosine-5-diphosphate (ADP). The glycerol-3phosphate is oxidized by glycerophosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. In the presence of peroxide, peroxidase catalyzes the coupling of 4-AAP (4-aminoantipyrine) with an N,N-disubstituted aniline to form a quinoneimine dye.
- The BioScanner Triglycerides Test Strips develop color on a dry membrane.
- The predicate device is a wet chemistry. The color of a solution is read.
- The BioScanner Triglycerides Test Strip separates the red blood cells, allowing the developed color to be read on the reaction area of the membrane.
- The BioScanner Triglycerides Test Strips contain a lot specific EEPROM memory chip in the same package with the strips. The EEPROM memory chip has the curve information programmed into it based on a multipoint curve that is established for the lot. The user inserts this chip into the instrument with each new lot of test strips. This chip is programmed with information that ensures that the correct lot of strips is used with the chip. If the memory chip and strip lot number do not match, the user will get an error message that keeps the user from running the test until the strip and memory chip are matched.
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1705 Triglyceride test system.
(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine 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.
0
MAY 2 4 2000
510(k) SUMMARY
This summary of safety and effectiveness information is submitted in compliance with 21CFR807.92.
Submitter 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
Trade Name: BioScanner Triglycerides Test Strips
Common Name: Triglyceride test system
Panel: Clinical Chemistry 75
Product Code: CDT
Device Classification: Class I
Intended Use:
The BioScanner Triglycerides test strips are intended to measure triglyceride in whole blood as an aid in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, or various endocrine disorders.
Device Description
Triglycerides are hydrolyzed by lipoprotein lipase to glycerol and fatty acid. Glycerol is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP) forming glycerol-3-phosphate and adenosine-5-diphosphate (ADP). The glycerol-3phosphate is oxidized by glycerophosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. In the presence of peroxide, peroxidase catalyzes the coupling of 4-AAP (4-aminoantipyrine) with an N,N-disubstituted aniline to form a quinoneimine dye.
Predicate Device Information
STATEMENT OF SUBSTANTIAL EQUIVALENCE
Polymer Technology Systems, Inc., intends to introduce into commercial distribution the BioScanner Triglycerides Test Strips for the quantitative determination of Triglyceride in human whole blood. The BioScanner Triglycerides Test Strips are substantially equivalent to the predicate device noted below.
| Name: | Triglyceride (GPO-Trinder) Reagent |
|---|---|
| Device Company: | Sigma |
| 510(k) Number: | K870012 |
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Similarities and Differences (Predicate and BioScanner Triglycerides)
Similarities
- Both systems determine total Triglyceride concentrations in blood. .
- . Both use a photometer to convert the intensity of color produced in a colorimetric chemical reaction into a triglyceride result.
- . Both reagents are similar in their composition in that both use a Trinder reaction to develop the colored end product. The color of the end product is measured and converted into triglyceride concentration and reported in mg/dL
Differences
-
- The color development media.
- The BioScanner Triglycerides Test Strips develop color on a dry membrane.
- The predicate device is a wet chemistry. The color of a solution is read.
-
- The method of red blood cell separation:
- . The predicate method does not separate the serum from the red blood cells. The whole blood must be centrifuged to separate the red blood cells.
- . The BioScanner Triglycerides Test Strip separates the red blood cells, allowing the developed color to be read on the reaction area of the membrane. ..............................................................................................................................................................................
3. The calibration method.
- The predicate method requires the running of a calibrator with each run.
- . The BioScanner Triglycerides Test Strips contain a lot specific EEPROM memory chip in the same package with the strips. The EEPROM memory chip has the curve information programmed into it based on a multipoint curve that is established for the lot. The user inserts this chip into the instrument with each new lot of test strips. This chip is programmed with information that ensures that the correct lot of strips is used with the chip. If the memory chip and strip lot number do not match, the user will get an error message that keeps the user from running the test until the strip and memory chip are matched.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 4 2000
Ms. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, Indiana 46268
Re: K991894
Trade Name: BioScanner Triglycerides Test Strips Regulatory Class: I Product Code: JGY Dated: March 13, 2000 Received: March 15, 2000
Dear Ms. Enright:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have and we 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 provision in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Connistions of the Act. The general controls provisions of the Act include requirements for annual provisions of the Pres. 900d 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remancer ripproval), in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to moponish the GMP regulation may result in regulatory action. In addition, FDA may publish compy wan also oncerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Usc
Center for Devices and Radiological Healt
Page
| 510(k) Number (if known): | 991894 |
|---|---|
| --------------------------- | -------- |
BioScanner Triglycerides Test Strips Device Name: _
Indications for Use:
The BioScanner Triglycerides test strips are intended to measure triglyceride in whole blood as an aid in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, or various endocrine disorders.
Itan Coopn
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991894
Prescription Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)