(58 days)
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.
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.
Here's an analysis of the provided text regarding the GLUCOMETER® DEX® TEST SENSOR, focusing on acceptance criteria and study details.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K012205) is a 510(k) Safety and Effectiveness Summary. It does not explicitly state numerical acceptance criteria in terms of accuracy metrics (e.g., specific MARD or percentage agreement targets relative to a reference method) that are typical for blood glucose meters. Instead, it describes general performance assessment and suitability for intended use.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suitable for intended use | "The studies demonstrated that the GLUCOMETER® DEX® Test Sensor (modified) is suitable for its intended use." |
| Satisfactory performance | "The results of the evaluation of the GLUCOMETER® DEX® Test Sensor (modified) demonstrate satisfactory performance..." |
| Linear response to glucose | "...linear response to glucose from 10-600 mg/dL." |
| Referenced to plasma glucose | "Blood glucose results are referenced to plasma glucose." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of participants or samples used in the clinical studies. It vaguely states: "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."
- Data Provenance: The document does not explicitly state the country of origin. Given the submitter's address (Elkhart, IN, USA) and the FDA approval process, it is highly likely the studies were conducted in the United States. The studies were a mix of in-house and clinical settings. The phrase "was studied... by persons with diabetes" implies prospective clinical studies involving intended users.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts or their specific qualifications for establishing ground truth. It mentions that performance was assessed "by healthcare professionals and by persons with diabetes," but it doesn't elaborate on the "ground truth" reference method or the personnel involved in its establishment. For blood glucose meters, ground truth is typically established by laboratory reference methods, not subjective expert consensus.
4. Adjudication Method for the Test Set
Not applicable. This device is a blood glucose sensor, and its performance is typically evaluated against an objective, laboratory-based reference method, not through adjudication by human readers/experts for image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not a diagnostic imaging device where MRMC studies are common. Its effectiveness is measured by its accuracy in glucose concentration measurement, not by how it assists human readers in interpreting results.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, implicitly. The "Assessment of Performance" section describes the evaluation of the "GLUCOMETER® DEX® Test Sensor (modified)" itself. The device is intended for self-monitoring and professional use, meaning its output (a glucose reading) is directly used. The studies would have focused on the accuracy of these readings, which is the standalone performance of the device.
7. The Type of Ground Truth Used
The document states: "Blood glucose results are referenced to plasma glucose." This indicates that the ground truth was established using a laboratory-based reference method for plasma glucose.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. This product (from 2001) is a blood glucose sensor based on a chemical/electrochemical method (amperometric glucose oxidase), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device's technology.
{0}------------------------------------------------
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 AvenueP.O. Box 70Elkhart, IN 46515(219) 262-6928 |
| Contact: | George M. Tancos R.A.C.Manager, Regulatory Compliance |
| Device: | Trade/Proprietary Name: GLUCOMETER ®DEX® TEST SENSORCommon/Usual Name: Test for glucose in whole bloodDocument Control Number: K01 2205 |
| Classification Name: | The GLUCOMETER® DEX® Test Sensor Disc and theGLUCOMETER® DEX family of blood glucose meters are used to testfor glucose in blood. In 21 CFR 862.1345, a glucose test system isclassified as a Class II medical device. |
| Predicate Devices: | GLUCOMETER® DEX Test Sensor Disc |
| Manufactured by: | Bayer Diagnostics430 S. Beiger St.Mishawaka, IN 46544 |
| Device Description: | The GLUCOMETER ® DEX® Test Sensor (modified) is for use with theGLUCOMETER® DEX® family of Blood Glucose Meters. TheGLUCOMETER DEX Blood Glucose Test System is an over-the-counter(OTC) home test for glucose in blood. The system is used by personswith diabetes and by healthcare professionals in home settings and inhealthcare facilities. |
| Intended Use: | The GLUCOMETER® DEX® Blood Glucose Test System is for theself-monitoring of blood glucose as an adjunct to the care of personswith diabetes. |
{1}------------------------------------------------
| Technological Characteristics: | The GLUCOMETER® DEX® Blood Glucose Testemploys and amperometric glucose oxidase method tomeasure glucose in blood. It is conceptually the same asother blood glucose monitoring products available forblood glucose testing. The Test Sensors are individuallysealed in cartridges of ten sensors. Blood glucose resultsare referenced to plasma glucose. TheGLUCOMETER® DEX® Blood Glucose System has alinear response to glucose from 10-600 mg/dL. |
|---|---|
| Assessment of Performance: | The performance of the GLUCOMETER® DEX® TestSensor (modified) was studied in both in-house andclinical settings by healthcare professionals and bypersons with diabetes. The studies demonstrated that theGLUCOMETER® DEX® Test Sensor (modified) issuitable for its intended use. |
| Conclusion: | The results of the evaluation of the GLUCOMETER®DEX® Test Sensor (modified) demonstrate satisfactoryperformance, 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.
{3}------------------------------------------------
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
§ 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.