(155 days)
Not Found
No
The description focuses on electrochemical biosensor technology and standard signal processing, with no mention of AI or ML terms or concepts.
No
The device is a monitoring system intended for in vitro diagnostic use to measure glucose and ß-ketone levels, not to provide therapy or treatment. Its purpose is to aid in monitoring the effectiveness of diabetes control programs.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "is intended for in vitro (outside the body) diagnostic use".
No
The device description clearly outlines a system that includes hardware components (monitor, test strips) that utilize electrochemical and enzymatic reactions to measure glucose and ketones. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The very first sentence explicitly states, "The Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use..." This is the defining characteristic of an IVD.
- Measurement of Analytes: The device measures glucose and ß-ketone in blood samples, which are biological specimens taken from the body.
- Diagnostic Purpose: While not for diagnosing diabetes, it is used as an "aid in monitoring the effectiveness of diabetes control programs," which is a diagnostic purpose related to managing a medical condition.
- Device Description: The description details how the device uses biosensor technology to measure these analytes in the sample found in the test strips, further confirming it analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (D-glucose) in fresh capillary, venous, arterial and neonatal whole blood samples, provided the sample is used within 30 minutes, and of ß-Ketone (beta-hydroxybutyrate) in fresh capillary and venous whole blood samples. The Precision Xceed Pro System is for home (lay user) or professional use. The system is not for use in diagnosing diabetes mellitus, but is to be used as an aid in monitoring the effectiveness of diabetes control programs.
The Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (Dglucose) in fresh capillary whole blood (fingertip), and of B-Ketone (beta hydroxybutyrate) in fresh capillary whole blood samples. The Precision Xceed Pro System is for home (lay user) or professional use. The system is not for use in diagnosing diabetes mellitus, but is to be used as an aid in monitoring the effectiveness of diabetes control programs.
Healthcare professionals may also use the product for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood and ketone in venous blood, provided the sample is used within 30 minutes after collection.
Product codes
NBW, LFR, JIN
Device Description
The Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System (BGKMS) utilizes amperometric biosensor technology to measure glucose and ß-ketone in the sample found in the Precision Xceed Pro test strips to quantitatively measure glucose and Bhydroxybutyrate (B-ketone) concentrations in whole blood samples and Precision, MediSense or Optium Control Solutions.
The Precision Xceed Pro BGKMS measures glucose electrochemically. The glucose biosensor is capable of determining glucose oxidized by the enzyme (Glucose Dehydrogenase, GDH) catalysed reaction with Nicotinamide Adenine Dinucleotide (NAD') cofactor. The reduced form of NAD (NADH) is re-oxidized by reaction with the electrochemical mediator, 1,10-phenanthroline quinone (1,10-PQ). The reduced mediator is re-oxidized via electron transfer at the electrode surface. This current is translated into a number by the monitor, after applying lot specific calibration information and after a 20 sccond countdown, a concentration value is presented to the user. In this same manner, the biosensor electrode utilizes the enzyme hydroxybutyrate Dehydrogenase (HBDH). which reacts with the ß-hydroxybutyrate (ß-ketone) concentration in the sample. This reaction is transferred to the monitor through an electrical current generated proportional to the level of ß-ketone in the sample. This current is translated into a number by the monitor, after applying lot specific calibration information and after a 10 second countdown, a concentration value is presented to the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (for capillary whole blood), Venous, Arterial, Neonatal whole blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home (lay user) or professional use
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: The modified blood glucose monitoring system was tested in accordance with ISO 15197:2003. Testing on dynamic range, precision, linearity, accuracy, and temperature were completed and all passed. These studies demonstrated that the Precision Xceed Pro BGKMS is substantially equivalent to the current Precision Xtra BGMS for blood glucose and B-ketone measurements and is suitable for its intended use.
Clinical Performance Data: The modified blood glucose monitoring system was also verified through clinical fingertip studies which were conducted to evaluate the accuracy, lay user acceptability and ease of use of the Precision Xceed Pro System (BGKMS). These studies demonstrated that the Precision Xceed Pro BGKMS is substantially equivalent to the current Precision Xtra BGMS for blood glucose and ß-ketone measurements and is suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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Image /page/0/Picture/1 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" on the left, followed by the words "Abbott" and "Diabetes Care" stacked on top of each other on the right. The text is in a bold, sans-serif font.
5 2008 SEP
Abbon Diabetes Care Ina 1360 Senth Loop Road Almoda ( 1 12 12 12 (1) 133 0 19 5219
510(k) Summary (as required by 21 CFR 807.92)
| Date Prepared: | April 1, 2008 |
|---|---|
| Company | Abbott Diabetes Care Inc. |
| Division | Abbott Diabetes Care Inc. |
| Street Address | 1360 South Loop Road |
| City, State Zip | Alameda, CA 94502 |
| Telephone No. | 510-749-5400 |
| Fax No. | 510-864-4791 |
| Contact Person: | Maria Trejo |
| Regulatory Affairs Associate | |
| Tel No. 510-749-6384 | |
| Fax No. 510-864-4791 | |
| maria.trejo@abbott.com | |
| Device Name: | Precision Xceed Pro Blood Glucose and β-Ketone |
| Monitoring System | |
| Common Name: | Blood Glucose Test System |
| Classification Name: | Glucose Dehydrogenase, Glucose, Class II (21 CFR |
| 862.1345) | |
| Ketones Test System, Ketones, Class I (21 CFR | |
| §862.1435) | |
| Product codes NBW, LFR, JIN | |
| Predicate Device: | Precision Xtra Diabetes Monitoring System (K040814) |
Description of the Device:
The Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System (BGKMS) utilizes amperometric biosensor technology to measure glucose and ß-ketone in the sample found in the Precision Xceed Pro test strips to quantitatively measure glucose and Bhydroxybutyrate (B-ketone) concentrations in whole blood samples and Precision, MediSense or Optium Control Solutions.
The Precision Xceed Pro BGKMS measures glucose electrochemically. The glucose biosensor is capable of determining glucose oxidized by the enzyme (Glucose Dehydrogenase, GDH) catalysed reaction with Nicotinamide Adenine Dinucleotide (NAD') cofactor. The reduced form of NAD (NADH) is re-oxidized by reaction with the electrochemical mediator, 1,10-phenanthroline quinone (1,10-PQ). The reduced mediator is re-oxidized via electron transfer at the electrode surface. This current is translated into a
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number by the monitor, after applying lot specific calibration information and after a 20 sccond countdown, a concentration value is presented to the user. In this same manner, the biosensor electrode utilizes the enzyme hydroxybutyrate Dehydrogenase (HBDH). which reacts with the ß-hydroxybutyrate (ß-ketone) concentration in the sample. This reaction is transferred to the monitor through an electrical current generated proportional to the level of ß-ketone in the sample. This current is translated into a number by the monitor, after applying lot specific calibration information and after a 10 second countdown, a concentration value is presented to the user.
Intended Use:
The Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (Dglucose) in fresh capillary, venous, arterial and neonatal whole blood samples, provided the sample is used within 30 minutes, and of ß-Ketone (beta-hydroxybutyrate) in fresh capillary and venous whole blood samples. The Precision Xceed Pro System is for home (lay user) or professional use. The system is not for use in diagnosing diabetes mellitus. but is to be used as an aid in monitoring the effectiveness of diabetes control programs.
Summary of Technological Characteristics:
The Precision Xceed Pro BGKMS has the same fundamental scientific technology and the same intended use as the current on-market Precision™ Xtra System which is based on the same amperometric biosensor technology. The Precision Xceed Pro BGKMS is substantially equivalent to the current predicate device.
Assessment of Non-Clinical Performance Data:
The modified blood glucose monitoring system was tested in accordance with ISO 15197:2003. The performance of the Precision Xceed Pro BGKMS has been verified through non-clinical testing in the laboratory. Testing on dynamic range, precision, linearity, accuracy, and temperature were completed and all passed. These studies demonstrated that the Precision Xceed Pro BGKMS is substantially equivalent to the current Precision Xtra BGMS for blood glucose and B-ketone measurements and is suitable for its intended use.
Assessment of Clinical Performance Data
The modified blood glucose monitoring system was also verified through clinical fingertip studies which were conducted to evaluate the accuracy, lay user acceptability and ease of use of the Precision Xceed Pro System (BGKMS). These studies demonstrated that the Precision Xceed Pro BGKMS is substantially equivalent to the current Precision Xtra BGMS for blood glucose and ß-ketone measurements and is suitable for its intended use.
Conclusion:
Results of non-clinical testing demonstrate that the performance of the Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System, when used according to the intended use stated above, is acceptable and substantially equivalent to the performance of the previously mentioned predicate device for blood glucose testing.
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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 consists of a stylized eagle with its wings spread, and three lines extending from the eagle's body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" are arranged in a circle around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
5 2008 SEP
Abbott Diabetes Carc. Inc. c/o Ms. Tammy Wharton Senior Regulatory Affairs Specialist 1360 South Loop Road Alameda, CA 94502
Re: K080960 Trade Name: Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW. LFR. JIN Dated: August 14, 2008 Received: August 15, 2008
Dear Ms. Wharton:
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 s logally 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) 276-0490. 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-freanumber (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean m. Cooper, M.S., D.v.M.
Séan M. Cooper, M.S., D.V.M. 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: K080960
Device Name: Precision Xceed Pro Blood Glucose and ß-Ketone Monitoring System
Indications for Use:
The Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (Dglucose) in fresh capillary whole blood (fingertip), and of B-Ketone (beta hydroxybutyrate) in fresh capillary whole blood samples. The Precision Xceed Pro System is for home (lay user) or professional use. The system is not for use in diagnosing diabetes mellitus, but is to be used as an aid in monitoring the effectiveness of diabetes control programs.
Healthcare professionals may also use the product for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood and ketone in venous blood, provided the sample is used within 30 minutes after collection.
Prescription User X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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