(52 days)
K 982002
Not Found
No
The device description details a chemical reaction and electrical current measurement to determine glucose concentration, with no mention of AI or ML.
No
The device is used for diagnosis and monitoring of glucose levels, not for treating any condition.
Yes
The "Intended Use / Indications for Use" states that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors," clearly indicating its use in diagnosis.
No
The device description explicitly states it reads an electrical current produced across two electrodes, indicating a hardware component is involved in the measurement process.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "measure glucose... in whole blood" and that these measurements are used in the "diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus". This clearly indicates that the device is used to examine specimens derived from the human body (whole blood) to provide information for diagnostic purposes.
- Device Description: The description details a chemical reaction that occurs with the blood sample and is then measured by the device to determine glucose concentration. This is a typical characteristic of an in vitro diagnostic test.
- Anatomical Site: The mention of "fingerstick whole blood" confirms that the device is analyzing a biological specimen taken from the body.
- Intended User / Care Setting: The intended users include both healthcare professionals and individuals at home, which is common for IVD devices used for monitoring conditions like diabetes.
The definition of an IVD generally includes devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. The BioScanner Beyond Glucose test system fits this definition.
N/A
Intended Use / Indications for Use
The BioScanner Beyond Glucose test system is intended to be used to measure glucose by healthcare professionals in whole blood and by individuals with diabetes at home in fingerstick whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
Glucose in the whole blood sample reacts with glucose oxidase and ferricyanide. The reaction liberates electrons, which produce a small electrical current. The BioScanner Beyond reads the current produced across two electrodes and converts current into glucose concentration.
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
healthcare professionals in whole blood and by individuals with diabetes at home in fingerstick whole blood.
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.
K 982002
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
§ 862.1345 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
NOV 1 62001
This summary of safety and effectiveness information is submitted in compliance with 21CFR807.92.
July 13, 2001
Submitter Information: Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268
Contact Person: Margo Enright Phone Number: 317-870-5610 317-870-5608 FAX Number:
Trade Name: BioScanner Beyond Glucose Test Strips
Common Name: Glucose test system
Panel: Clinical Chemistry 75
Product Code: NBW
Device Classification: Class II
Intended Use
The BioScanner Beyond Glucose test system is intended to be used to measure glucose by healthcare professionals in whole blood and by individuals with diabetes at home in fingerstick whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors.
Device Description
Glucose in the whole blood sample reacts with glucose oxidase and ferricyanide. The reaction liberates electrons, which produce a small electrical current. The BioScanner Beyond reads the current produced across two electrodes and converts current into glucose concentration.
Predicate Device Information
STATEMENT OF SUBSTANTIAL EQUIVALENCE
Polymer Technology Systems, Inc., intends to introduce into commercial distribution the BioScanner Beyond Glucose Test Strips for the quantitative determination of Glucose in human whole blood. The BioScanner Beyond Glucose Test Strips are substantially equivalent to the predicate device noted below.
Accu-Chek Comfort Curve Test Strips Name: Roche Diagnostics Device Company: K 982002 510(k) Number:
1
Similarities and Differences (Predicate and BioScanner Beyond Glucose)
Similarities
- Both systems measure Glucose concentrations in blood. .
- Both systems provide a result that correlates to the laboratory plasma glucose . result.
- Both systems are calibrated with a glucose hexokinase laboratory method as the . reference.
- Both use the same testing principle (amperometric method) in which a small . current produced in a chemical reaction is measured and converted into a glucose result in concentration.
- Both reagents are similar in their composition in that both use a glucose oxidase . reaction. The current is measured and converted into glucose concentration and reported in mg/dL
- The predicate method requires an Accu-Chek code chip to access the lot code ● information ..
The BioScanner Beyond Glucose Test Strips contain a lot specific memory chip in the same package with the strips.
Differences
- The BioScanner Beyond Glucose Analyzer requires about one-half of blood ● sample volume that the Accu-Chek Advantage requires
- The BioScanner Beyond Glucose Analyzer has a display screen that is about 7% ◆ larger than the Accu-Chek Advantage
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human figures or abstract shapes, possibly representing people or services provided by the department.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268
NOV 1 62001
Re: K013203
Trade/Device Name: Bioscanner Beyond Glucose Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW, CGA Dated: September 24, 2001 Received: September 25, 2001
Dear Mr. Enright:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning 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 1 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 International and Consumer 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 Sutman
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
4
NOV 1 62001
Page
NUMBER (IF KNOWN) : 510 (k)
DEVICE NAME: BioScanner Beyond Glucose Test System
INDICATIONS FOR USE:
The BioScanner Beyond Glucose test system is intended to measure glucose by healthcare professionals in whole blood and by individuals with diabetes at home in fingerstick whole blood. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors.
Han Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013203
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(Optional Format 1-2-96)