(48 days)
No
The 510(k) summary describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No.
The device is used for monitoring blood glucose levels, which assists in the management of diabetes, but it does not directly treat or cure the condition.
Yes
The device is used for the "measurement of glucose in whole blood" and its frequent monitoring is an "adjunct to the care of persons with diabetes," indicating it provides information that contributes to diagnosis, treatment, and management of a disease.
No
The device description explicitly states that the system contains a meter, controls, lancing device, and test strips, which are all hardware components.
Yes, based on the provided information, the Ascensia® CONTOUR® Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for the "measurement of glucose in whole blood." This involves testing a biological sample (blood) outside of the body to provide information about a person's health status (diabetes).
- Device Description: It describes a "system" that includes a "test strip" used for the "measurement of glucose in whole blood." This further reinforces the in vitro nature of the testing.
- Sample Type: It specifies the use of "whole blood samples" (capillary, venous, and arterial). This is a biological specimen analyzed outside the body.
- Regulatory Context: The mention of a "Predicate Device(s)" with a K number (K023657) indicates that this device has gone through a regulatory submission process, likely a 510(k) in the US, which is the typical pathway for IVD devices.
Therefore, the core function of the device - analyzing a biological sample (blood) outside the body to diagnose or monitor a medical condition (diabetes) - aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip) is used for the measurement of glucose in whole blood. The Ascensia® Contour® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The Ascensia ® CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, abdomen and thigh. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
Product codes
NBW, LFR
Device Description
The Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip) is used for the measurement of glucose in whole blood. The strip is one component of a system that also contains a meter, controls, lancing device, and instructions for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip, palm, forearm, abdomen and thigh (for capillary samples)
Indicated Patient Age Range
Not Found
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
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)
An evaluation of the Ascensia® CONTOUR® Blood Glucose Monitoring System (modified test strip) was studied in the laboratory and in a clinical setting by persons with diabetes. The results were compared to results from the original Ascensia® CONTOUR® Blood Glucose Monitoring System and to a laboratory method. The studies showed equivalent performance with the original Ascensia® CONTOUR® Blood Glucose Monitoring System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Ascensia® CONTOUR® Diabetes Care System, K023657
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Bayer HealthCare Diabetes Care Division
APR 1 2 2006
Image /page/0/Picture/2 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged vertically in a circular shape. The letters are bold and capitalized, and the circle is made up of two concentric rings.
510(k) SUMMARY
Ascensia® CONTOUR® Blood Glucose Monitoring System (Modified Test Strip)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is | K060470 |
---|---|
Prepared: | February 22, 2006 |
Submitter: | Bayer HealthCare, Diabetes Care Division |
Address: | 430 South Beiger Street |
Mishawaka, IN 46544 | |
Phone (574) 262-7152; FAX (574) 262 6945 | |
Contact: | Roger Sonnenburg, Regulatory Affairs Manager |
Device: | Trade/Proprietary Name: Ascensia® CONTOUR® Blood |
Glucose Monitoring System | |
Common/Usual Name: | Blood Glucose Meter |
Classification: | Division of Clinical Laboratory Devices |
Panel - Clinical Chemistry and Toxicology | |
Classification Code - 75 LFR, Glucose Dehydrogenase, | |
Glucose | |
Predicate Devices: | Ascensia® CONTOUR® Diabetes Care System, K023657 |
Device Description: | The Ascensia® CONTOUR® Blood Glucose Monitoring |
System (modified test strip) is used for the measurement of | |
glucose in whole blood. The strip is one component of a | |
system that also contains a meter, controls, lancing device, | |
and instructions for use. |
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510(k) Summary, continued Ascensia Contour Blood Glucose Monitoring System (modified test strip) Page 2 of 2
| Intended Use: | The Ascensia® CONTOUR® Blood Glucose Monitoring
System (modified test strip) is used for the measurement of
glucose in whole blood. The Ascensia® Contour® Blood
Glucose Monitoring System is an over-the-counter (OTC)
device used by persons with diabetes and by healthcare
professionals in home settings and in healthcare facilities.
The Ascensia® CONTOUR® Blood Glucose Monitoring
System is indicated for use with capillary, venous, andarterial whole blood samples. Capillary samples may be
drawn from the fingertip, palm, forearm, abdomen and thigh. |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | There were no changes to the fundamental scientific
technology. |
| Comparison to
Predicate device: | The modifications to the device encompass a design
change, a labeling change, and a material change. There
has been no change to the intended use, operating principle,
or functionality of the device. |
| Assessment of
Performance: | An evaluation of the Ascensia® CONTOUR® Blood Glucose
Monitoring System (modified test strip) was studied in the
laboratory and in a clinical setting by persons with diabetes.
The results were compared to results from the original
Ascensia® CONTOUR® Blood Glucose Monitoring System
and to a laboratory method. The studies showed equivalent
performance with the original Ascensia® CONTOUR® Blood
Glucose Monitoring System. |
| Conclusion: | The results of the laboratory and clinical evaluations of the
Ascensia® CONTOUR® Blood Glucose Monitoring System
(modified test strip) demonstrated that the device produces
blood glucose results that are substantially equivalent to
results obtained on the predicate device. Therefore, the
system with the modified strip is as safe and effective as the |
original system. •
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 2 2006
Mr. Roger Sonnenburg Manager of Regulatory Affairs Bayer HealthCare, Diabetes Care Division 430 South Beiger Street Mishawaka, IN 46544
Re: K060470
Trade/Device Name: Ascensia® Contour® Blood Glucose Monitoring System (modified test strip) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, LFR Dated: February 22, 2006 Received: February 23, 2006
Dear Mr. Sonnenburg:
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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Alberto Gutierrez
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060470
Device Name: Ascensia Contour® Blood Glucose Monitoring System (modified test strip)
Indications For Use: The Ascensia® CONTOUR® Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia® CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
The Ascensia ® CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, abdomen and thigh.
The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
Prescription Use X (Part 21 CFR 801 Subpart D) ÁNDYOR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Carol C. Benson
Division Sign-Off
Office of In Vitro Dlagnostic Device Evaluation and Safety
510(k)
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