(209 days)
Not Found
No
The device description focuses on electrochemical principles and does not mention any AI/ML components or algorithms. The performance studies are standard clinical and non-clinical tests for glucose meters.
No.
The device is an in vitro diagnostic (IVD) test strip used to quantitatively measure glucose, which aids in monitoring the effectiveness of diabetes control programs. It is not used for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The test strips are for use outside the body (in vitro diagnostic use)". Additionally, the strips "quantitatively measure glucose (D-glucose) in fresh neonatal, venous, arterial and fingertip capillary whole blood" and are used as "an aid in monitoring the effectiveness of diabetes control programs," which are diagnostic functions.
No
The device description clearly outlines a physical test strip utilizing amperometric biosensor technology and interacting with a meter, indicating it is a hardware component, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The test strips are for use outside the body (in vitro diagnostic use)..."
- Mechanism: The "Device Description" describes a chemical reaction and electrochemical measurement performed on a blood sample, which is characteristic of in vitro diagnostics.
- Purpose: The device measures a substance (glucose) in a biological sample (blood) to provide information about a patient's health status (monitoring diabetes control). This aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
The Precision® and Optium® Point of Care Blood Test Strips quantitatively measure glucose (D-glucose) in fresh neonatal, venous, arterial and fingertip capillary whole blood. The test strips are for use outside the body (in vitro diagnostic use) by healthcare professionals for use in healthcare facilities with either the Precision Xtra® or Optium® Blood Glucose Monitoring Systems. Home users may use the system for capillary samples only. The test strips are not for use in diagnosis or screening of diabetes mellitus, but are to be used as an aid in monitoring the effectiveness of diabetes control programs.
Product codes
LFR, NBW
Device Description
The Precision® /Optium® Point of Care Blood Glucose Test Strips work on the principle of amperometric biosensor technology, by determination of glucose oxidised by the enzyme (Glucose Dehydrogenase, GDH) catalysed reaction with Nicotinamide Adenine Dinucleotide (NAD). The reduced form of NAD (NADH) is re-oxidized by reaction with the electrochemical mediator, 1,10 phenanthroline quinone (1,10PQ). The reduced mediator is re-oxidized via electron transfer at the electrode surface. This current is translated into a number by the meter, after applying lot specific information from the supplied ROM calibrator and after a 20 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
Not Found
Indicated Patient Age Range
neonatal
Intended User / Care Setting
healthcare professionals for use in healthcare facilities; Home users
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)
The performance of the Precision®/Optium® Point of Care Blood Glucose Test Strips was verified through non clinical testing in the laboratory. These studies demonstrated that the Precision® Point of Care Blood Glucose Test Strips/ Optium® Point of Care Blood Glucose Test Strips are substantially equivalent to the current Precision® Point of Care Blood Glucose Test Strips/Optium® Point of Care Blood Glucose Test Strips for blood glucose measurements and are suitable for its intended use.
The performance of the Precision®/Optium® Point of Care Blood Glucose Test Strips was also verified through clinical testing. Some of the test performed and passed were altitude, dynamic range, precision , linearity, accuracy, interference, oxygen sensitivity, environmental, hematocrit, shipping and shelf life. These studies demonstrated that the Precision® Point of Care Blood Glucose Test Strips/ Optium® Point of Care Blood Glucose Test Strips are substantially equivalent to the current Precision® Point of Care Blood Glucose Test Strips/Optium® Point of Care Blood Glucose Test Strips for blood glucose measurements and are suitable for its intended use.
Results of clinical and non-clinical testing demonstrate that the performance of the Precision® Point of Care Blood Glucose Test Strips and Optium® Point of Care Blood Glucose Test Strips, when used according to the intended use stated above, are acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose testing.
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.
0
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.
Abbott Diabetes Care Inc. 1360 South I oop Road Alameda, CA 94502 t: (510) 749-5400
NOV - 1 2007
510(k) Summary
(as required by 21 CFR 807.92)
| Date Prepared: | October 09, 2007 |
|---|---|
| Company | Abbott Laboratories |
| 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® Point of Care Blood Glucose Test Strip |
| Optium® Point of Care Blood Glucose Test Strip | |
| Common Name: | Blood Glucose Test Strip |
| Classification Name: | Glucose Dehydrogenase, Glucose. Glucose Test System, |
| Class II (21 CFR §862.1345, Product code LFR) | |
| Predicate Device: | Precision®/ Optium® Point of Care Blood Glucose Test |
| Strips (K021960) |
Description of the Device:
The Precision® /Optium® Point of Care Blood Glucose Test Strips work on the principle of amperometric biosensor technology, by determination of glucose oxidised by the enzyme (Glucose Dehydrogenase, GDH) catalysed reaction with Nicotinamide Adenine Dinucleotide (NAD). The reduced form of NAD (NADH) is re-oxidized by reaction with the electrochemical mediator, 1,10 phenanthroline quinone (1,10PQ). The reduced mediator is re-oxidized via electron transfer at the electrode surface. This current is translated into a number by the meter, after applying lot specific information from the supplied ROM calibrator and after a 20 second countdown, a concentration value is presented to the user.
1
Image /page/1/Picture/0 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.
Intended Use:
The Precision®/Optium® Point of Care Blood Glucose Test Strips quantitatively measure I he I receision > Operain > > Sprain > > arterial and fingertip capillary whole blood. The test strips are for use outside the body (in vitro diagnostic use) by healthcare I no cost surpo are in healthcare facilities with either the Precision Xtra® or Optium® Blood Glucose Monitoring Systems. Home users may use the system for capillary samples only. The test strips are not for use in diagnosis or screening of diabetes mellitus, but are to be used as an aid in monitoring the effectiveness of diabetes control programs.
Summary of Technological Characteristics:
The Precision® Point of Care Blood Glucose Test Strips/ Optium® Point of Care Blood Glucose Test Strips have the same fundamental scientific technology and the same intended use as the current Precision® Point of Care Blood Glucose Test Strips and Optium® Point of Care Blood Glucose Test Strips which is based on amperometric biosensor technology. The Precision® Point of Care Blood Glucose Test Strips/ Optium® Point of Care Blood Glucose Test Strips are substantially equivalent to the current predicate device.
Assessment of Non-Clinical Performance Data:
The performance of the Precision®/Optium® Point of Care Blood Glucose Test Strips was verified through non clinical testing in the laboratory. These studies demonstrated that the Precision® Point of Care Blood Glucose Test Strips/ Optium® Point of Care Blood Glucose Test Strips are substantially equivalent to the current Precision® Point of Care Blood Glucose Test Strips/Optium® Point of Care Blood Glucose Test Strips for blood glucose measurements and are suitable for its intended use.
Assessment of Clinical Performance Data:
The performance of the Precision®/Optium® Point of Care Blood Glucose Test Strips was also verified through clinical testing. Some of the test performed and passed were altitude, dynamic range, precision , linearity, accuracy, interference, oxygen sensitivity, environmental, hematocrit, shipping and shelf life. These studies demonstrated that the Precision® Point of Care Blood Glucose Test Strips/ Optium® Point of Care Blood Glucose Test Strips are substantially equivalent to the current Precision® Point of Care Blood Glucose Test Strips/Optium® Point of Care Blood Glucose Test Strips for blood glucose measurements and are suitable for its intended use.
Conclusion:
Results of clinical and non-clinical testing demonstrate that the performance of the Precision® Point of Care Blood Glucose Test Strips and Optium® Point of Care Blood Glucose Test Strips, when used according to the intended use stated above, are acceptable and comparable to the performance of the previously mentioned predicate device for blood glucose testing.
2
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 lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Abbott Laboratories Abbott Diabetes Care Inc. c/o Ms. Maria Trejo Regulatory Affairs Associate 1360 South Loop Road Alameda, CA 94502
NOV - 1 2007
Re: K070984
Trade/Device Name: Precision® Point of Care Blood Glucose Test Strips Optium® Point of Care Blood Glucose Test Strips Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Code: LFR, NBW Dated: October 10, 2007 Received: October 15, 2007
Dear Ms. Trejo:
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).
3
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) 276-0490. 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-free number (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.
Jean 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
4
Indications for Use
510(k) Number (if known): K070984
Device Name: Precision® Point of Care Blood Glucose Test Strips Optium® Point of Care Blood Glucose Test Strips
Indications for Use:
The Precision® and Optium® Point of Care Blood Test Strips quantitatively measure glucose (D-glucose) in fresh neonatal, venous, arterial and fingertip capillary whole blood. The test strips are for use outside the body (in vitro diagnostic use) by healthcare professionals for use in healthcare facilities with either the Precision Xtra® or Optium® Blood Glucose Monitoring Systems. Home users may use the system for capillary samples only. The test strips are not for use in diagnosis or screening of diabetes mellitus, but are to be used as an aid in monitoring the effectiveness of diabetes control programs.
Prescription Use 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
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Ben
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ിfice of In Vitro Diagnostic Device I Valuation and Safety
K070984j