(58 days)
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No
The document describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No.
The device is used to measure glucose levels, which is a diagnostic function, not a therapeutic intervention.
Yes
The device is used to measure the glucose level in whole blood, which provides information for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes. This act of measuring and providing information to aid in disease management qualifies it as a diagnostic device.
No
The device description explicitly states it is a "Test Sensor" for use with "Blood Glucose Meters," indicating a physical component (the sensor) and a hardware device (the meter) are integral to its function. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "measure the glucose level in whole blood." This is a diagnostic measurement performed on a biological sample (blood) outside of the body.
- Device Description: The description reinforces that it's a "home test for glucose in blood" and is part of a "Blood Glucose Test System."
- Anatomical Site: The specified anatomical site is "whole blood," which is a biological specimen.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The GLUCOMETER® DEX® Blood Glucose Test System is for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes.
The GLUCOMETER® DEX® TEST SENSOR is used with the GLUCOMETER® DEX® and GLUCOMETER® DEX®2 Blood Glucose Meters to measure the glucose level in whole blood. The GLUCOMETER® DEX Blood Glucose System is a home use (OTC) device used by persons with diabetes, and by health care professionals in clinical settings for the selfmonitoring of blood glucose as an adjunct to the care of persons with diabetes.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The GLUCOMETER ® DEX® Test Sensor (modified) is for use with the GLUCOMETER® DEX® family of Blood Glucose Meters. The GLUCOMETER DEX Blood Glucose Test System is an over-the-counter (OTC) home test for glucose in blood. The system is used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the GLUCOMETER® DEX® Test Sensor (modified) was studied in both in-house and clinical settings by healthcare professionals and by persons with diabetes. The studies demonstrated that the GLUCOMETER® DEX® Test Sensor (modified) is suitable for its intended use.
The results of the evaluation of the GLUCOMETER® DEX® Test Sensor (modified) demonstrate satisfactory performance, and are suitable for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
GLUCOMETER® DEX Test Sensor Disc
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.
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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).
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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.
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SEP 1 2 2001
GLUCOMETER® DEX® TEST SENSOR
GLUCOMETER® DEX® TEST SENSOR
GLUCOMETER® DEX® TEST SENSOR Page 1 of 2
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | July 13, 2001 |
|---|---|
| Submitter: | Bayer Diagnostics |
| Address: | 1884 Miles Avenue |
| P.O. Box 70 | |
| Elkhart, IN 46515 | |
| (219) 262-6928 | |
| Contact: | George M. Tancos R.A.C. |
| Manager, Regulatory Compliance | |
| Device: | Trade/Proprietary Name: GLUCOMETER ®DEX® TEST SENSOR |
| Common/Usual Name: Test for glucose in whole blood | |
| Document Control Number: K01 2205 | |
| Classification Name: | The GLUCOMETER® DEX® Test Sensor Disc and the |
| GLUCOMETER® DEX family of blood glucose meters are used to test | |
| for glucose in blood. In 21 CFR 862.1345, a glucose test system is | |
| classified as a Class II medical device. | |
| Predicate Devices: | GLUCOMETER® DEX Test Sensor Disc |
| Manufactured by: | Bayer Diagnostics |
| 430 S. Beiger St. | |
| Mishawaka, IN 46544 | |
| Device Description: | The GLUCOMETER ® DEX® Test Sensor (modified) is for use with the |
| GLUCOMETER® DEX® family of Blood Glucose Meters. The | |
| GLUCOMETER DEX Blood Glucose Test System is an over-the-counter | |
| (OTC) home test for glucose in blood. The system is used by persons | |
| with diabetes and by healthcare professionals in home settings and in | |
| healthcare facilities. | |
| Intended Use: | The GLUCOMETER® DEX® Blood Glucose Test System is for the |
| self-monitoring of blood glucose as an adjunct to the care of persons | |
| with diabetes. |
1
| Technological Characteristics: | The GLUCOMETER® DEX® Blood Glucose Test
employs and amperometric glucose oxidase method to
measure glucose in blood. It is conceptually the same as
other blood glucose monitoring products available for
blood glucose testing. The Test Sensors are individually
sealed in cartridges of ten sensors. Blood glucose results
are referenced to plasma glucose. The
GLUCOMETER® DEX® Blood Glucose System has a
linear response to glucose from 10-600 mg/dL. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assessment of Performance: | The performance of the GLUCOMETER® DEX® Test
Sensor (modified) was studied in both in-house and
clinical settings by healthcare professionals and by
persons with diabetes. The studies demonstrated that the
GLUCOMETER® DEX® Test Sensor (modified) is
suitable for its intended use. |
| Conclusion: | The results of the evaluation of the GLUCOMETER®
DEX® Test Sensor (modified) demonstrate satisfactory
performance, and are suitable for their intended use. |
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three overlapping human profiles or a bird in flight, rendered in black.
SEP 1 2 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. George M. Tancos R.A.C. Manager, Regulatory Compliance Bayer Group Diagnostics 1884 Miles Avenue P.O. Box 70 Elkhart, IN 46515-0070
K012205 Re:
Trade/Device Name: Glucometer ® Dex® Test Sensor Regulation Number: 21 CFR 862.1345 Regulatory Class: II Product Code: NBW Dated: July 13, 2001 Received: July 16, 2001
Dear Mr. Tancos:
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/cdrb/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
4
510(k) Number (if known): K01 220 5
Device Name:
Indications for Use:
GLUCOMETER® DEX® TEST SENSOR
The GLUCOMETER® DEX® TEST SENSOR is used with the GLUCOMETER® DEX® and GLUCOMETER® DEX®2 Blood Glucose Meters to measure the glucose level in whole blood. The GLUCOMETER® DEX Blood Glucose System is a home use (OTC) device used by persons with diabetes, and by health care professionals in clinical settings for the selfmonitoring of blood glucose as an adjunct to the care of persons with diabetes.
(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)
PageX
Kesia Alexander for Sean Cooper
Division of Clinical Laboratory Devices 012 206 510(k) Number