(453 days)
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No
The description focuses on the device's function as an amperometric biosensor for quantitative glucose measurement and does not mention any AI or ML capabilities.
No
This device is a blood glucose monitoring system, intended to measure glucose levels as an aid to monitor the effectiveness of diabetes control. It does not provide therapy.
Yes
The device is an in vitro diagnostic (IVD) device used for the quantitative measurement of glucose in blood samples, which is a diagnostic function. The text explicitly states "in vitro diagnostic use" multiple times.
No
The device description explicitly states that the system consists of a meter, test strips, and control solutions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statements for all four systems (TysonBio AC100, AC100 Pro, AC200, and AC200 Pro) explicitly state that they are intended for "testing outside the body (in vitro diagnostic use)".
Furthermore, the device description confirms that the system measures glucose in blood samples, which is a classic example of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
TysonBio AC100 Blood Glucose Monitoring System:
The TysonBio AC100 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The TysonBio AC100 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio AC100 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio AC100 contains a voice function but this function is not intended for users with impaired vision.
The TysonBio AC100 Test Strips are for use with the TysonBio AC100 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
TysonBio AC100 Pro Blood Glucose Monitoring System:
The TysonBio AC100 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC100 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices.
The TysonBio AC100 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio AC100 Pro contains a voice function but this function is not intended for users with impaired vision.
The TysonBio AC100 Pro Blood Glucose Test Strips are for use with the TysonBio AC100 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
TysonBio AC200 Blood Glucose Monitoring System:
The TysonBio AC200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The TysonBio AC200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio AC200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The TysonBio AC200 Test Strips are for use with the TysonBio AC200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
TysonBio AC200 Pro Blood Glucose Monitoring System:
The TysonBio AC200 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC200 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices.
The TysonBio AC200 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The TysonBio AC200 Pro Blood Glucose Test Strips are for use with the TysonBio AC200 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
Product codes
CGA, NBW
Device Description
The TysonBio AC100/AC100 Pro Blood Glucose Monitoring System and the TysonBio AC200/AC200 Pro Blood Glucose Monitoring System is an amperometric biosensor, It is adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. The TysonBio AC100/AC100 Pro Blood Glucose Monitoring System and the TysonBio AC200/AC200 Pro Blood Glucose Monitoring System consist of three main products: the meter, Test Strips and Control Solutions. Use only TysonBio AC100/AC100 Pro Test Strips for TysonBio AC100/AC100 Pro Blood Glucose Monitoring Systems, TysonBio AC200/AC200 Pro Test Strips for TysonBio AC200/AC200 Pro Blood Glucose Monitoring Systems, and use TysonBio AC100/AC100 Pro Control Solutions for TysonBio AC100/AC100 Pro Blood Glucose Monitoring Systems, TysonBio AC200/AC200 Pro Control Solutions for TysonBio AC200/AC200 Pro Blood Glucose Monitoring Systems to perform quality checks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips, forearm, palm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
TysonBio AC100/AC200 Blood Glucose Monitoring System: single person, at home use by people with diabetes.
TysonBio AC100 Pro/AC200 Pro Blood Glucose Monitoring System: multiple-patient use in professional healthcare settings.
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)
Evaluations of the TysonBio AC100 / A100 Pro Blood Glucose Monitoring System and the TysonBio AC200 / AC200 Pro Blood Glucose Monitoring System were studied in the laboratory and in a clinical setting using persons with diabetes. The results were compared to results from the currently marketed Easy Step Blood Glucose Monitoring System and to a laboratory method. The studies showed substantially equivalent performance with the current Easy Step Blood Glucose Monitoring System.
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.
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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510(k) SUMMARY
AUG 3 0 2011
- Date prepared August 28, 2011
2. Sponsor information
Tyson Bioresearch, Inc. · 5 F., # 22, Ke E. Road iii., science based industrial park Chun-Nan, Miao-Li county, Taiwan 350
Correspondent: WEN-HAI TSAI Phone: 886-37-585988 Facsimile: 886-37-585996
3. Device name and classification
Device Name:
TysonBio AC100 Blood Glucose Monitoring System TysonBio AC100 Pro Blood Glucose Monitoring System TysonBio AC200 Blood Glucose Monitoring System TysonBio AC200 Pro Blood Glucose Monitoring System
Common Names: Blood Glucose Monitoring System
Classification: Classification: Class II Classification Regulation: 21 CFR 862.1345 Product Code: CGA (Glucose Oxidase, Glucose) NBW (System, Test, Blood Glucose, Over The Counter) Panel - Clinical Chemistry and Toxicology
4. Device description
The TysonBio AC100/AC100 Pro Blood Glucose Monitoring System and the TysonBio AC200/AC200 Pro Blood Glucose Monitoring System is an amperometric biosensor, It is adopted for its ease of use, its ability to process accurate results utilizing only a small volume of blood, and its quick response time. The TysonBio AC100/AC100 Pro Blood Glucose Monitoring System and the TysonBio AC200/AC200 Pro Blood Glucose Monitoring System consist of three main products: the meter, Test Strips and Control Solutions. Use only
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TysonBio AC100/AC100 Pro Test Strips for TysonBio AC100/AC100 Pro Blood Glucose Monitoring Systems, TysonBio AC200/AC200 Pro Test Strips for TysonBio AC200/AC200 Pro Blood Glucose Monitoring Systems, and use i TysonBio AC100/AC100 Pro Control Solutions for TysonBio AC100/AC100 Pro Blood Glucose Monitoring Systems, TysonBio AC200/AC200 Pro Control Solutions for TysonBio AC200/AC200 Pro Blood Glucose Monitoring Systems to perform quality checks.
5. Intended use
TysonBio AC100 Blood Glucose Monitoring System:
The TysonBio AC100 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The TysonBio AC100 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio AC100 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio AC100 contains a voice function but this function is not intended for users with impaired vision.
The TysonBio AC100 Test Strips are for use with the TysonBio AC100 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
TysonBio AC100 Pro Blood Glucose Monitoring System:
The TysonBio AC100 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC100 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices.
The TysonBio AC100 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not
2
changing rapidly). The TysonBio AC100 Pro contains a voice function but this function is not intended for users with impaired vision.
The TysonBio AC100 Pro Blood Glucose Test Strips are for use with the TysonBio AC100 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
TysonBio AC200 Blood Glucose Monitoring System:
The TysonBio AC200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The TysonBio AC200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio AC200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The TysonBio AC200 Test Strips are for use with the TysonBio AC200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
TysonBio AC200 Pro Blood Glucose Monitoring System:
The TysonBio AC200 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC200 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices.
The TysonBio AC200 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The TysonBio AC200 Pro Blood Glucose Test Strips are for use with the TysonBio AC200 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
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6. Test principle
The test principle is based on electrochemical biosensor technology using glucose oxidase. There has been no change to the fundamental scientific technology.
7. Predicate device
Easy Step Blood Glucose Monitoring System (K090629)
Comparison to predicate device
The modifications to the device encompass:
- Addition of selectable voice guidance on/off function (for TysonBio AC100 model only)
- · Addition of hypoglycemic and hypoglycemic alarm setting
- · Removal of backlight
- · Extension of meter memory capacities
- · Changes in outer case appearance
- · Change to auto coding.
There have been no changes to the operating principle, intended use or functionality.
8. Performance characteristic summary
Evaluations of the TysonBio AC100 / A100 Pro Blood Glucose Monitoring System and the TysonBio AC200 / AC200 Pro Blood Glucose Monitoring System were studied in the laboratory and in a clinical setting using persons with diabetes. The results were compared to results from the currently marketed Easy Step Blood Glucose Monitoring System and to a laboratory method. The studies showed substantially equivalent performance with the current Easy Step Blood Glucose Monitoring System.
9. Conclusion
The TysonBio AC100 / AC200 Blood Glucose Monitoring System is substantially equivalent to the predicate Easy Step Blood Glucose Monitoring System.
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, a symbol often associated with healthcare, with three horizontal lines that curve and flow together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Tyson Bioresearch Inc. c/o Wen-Hai Tsai 5F, #22, Ke E. Road III, Science-Based Industrial Park Chun-Nan, Miao-Li County China (Taiwan) 350
AUG 3 0 2011
Re: K101543 TysonBio AC100/AC100Pro/AC200Pro Blood Glucose Monitoring System Trade/Device Name: Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: 'July 21, 2011 Received: August 25, 2011
Dear Mr. Tsai
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).
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.
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.hum for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/McdicalDevicesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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510(k) Number (if known): K101543
Device Name: TysonBio AC100 Pro Blood Glucose Monitoring System
Indication for Use:
The TysonBio AC100 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC100 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices.
The TysonBio AC100 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio AC100 Pro contains a voice function but this function is not intended for users with impaired vision.
The TysonBio AC100 Pro Blood Glucose Test Strips are for use with the TysonBio AC100 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
Prescription Use (21 CFR Part 801 Subpart D)
And/Or Over the Counter Use _ × (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KIO1543
off
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510(k) Number (if known): _
Device Name: TysonBio AC100 Blood Glucose Monitoring System
Indication for Use:
The TysonBio AC100 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The TysonBio AC100 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio AC100 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). The TysonBio AC100 contains a voice function but this function is not intended for users with impaired vision.
The TysonBio AC100 Test Strips are for use with the TysonBio AC100 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ And/Or Over the Counter Use (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
s
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)________________________________________________________________________________________________________________________________________________________________________
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: TysonBio AC200 Pro Blood Glucose Monitoring System
Indication for Use:
The TysonBio AC200 Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, or forearm. The TysonBio AC200 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices.
The TysonBio AC200 Pro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
The TysonBio AC200 Pro Blood Glucose Test Strips are for use with the TysonBio AC200 Pro Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
And/Or Over the Counter Use __ × Prescription Use (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
KIDI543 510(k)________________________________________________________________________________________________________________________________________________________________________
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510(k) Number (if known):
Device Name: TysonBio AC200 Blood Glucose Monitoring System
Indication for Use:
The TysonBio AC200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The TysonBio AC200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio AC200 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).
- · The TysonBio AC200 Test Strips are for use with the TysonBio AC200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
And/Or Over the Counter Use ___X Prescription Use (21 CFR Part 801 Subpart D) (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
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