(238 days)
The AutoSure Voice II Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. The meter includes voice functionality to assist visually impaired users. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring blood glucose levels in diabetes mellitus. This system is for single-patient use only and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use.
The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
The AutoSure Voice II Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. The meter includes voice functionality to assist visually impaired users. It is intended for multiple-patient use in professional healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus. This system should only be used with single-use auto-disabling lancing devices. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use.
The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice II Pro Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.
The AutoSure Voice II Blood Glucose Monitoring System consists of the AutoSure Voice II Meter and AutoSure Blood Glucose Test Strips. It is used for testing of blood glucose by self-testers at home. The AutoSure Voice II Pro Blood Glucose Monitoring System consists of the AutoSure Voice II Pro Meter and AutoSure Pro Blood Glucose Test Strips. It is used for testing of blood glucose by professional testers in healthcare facilities. The AutoSure Voice II and AutoSure Voice II Pro systems are identical other than trade names and details of product labeling.
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Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
Device Name: AutoSure Voice II Blood Glucose Monitoring System and AutoSure Voice II Pro Blood Glucose Monitoring System
Reason for 510(k): The submission (K150396) appears to be for a modified version of an existing device (predicate device K102037). The modifications described are:
* Separation of self-testing and professional usage claims into two distinct products.
* Recommendation of four additional disinfectants in the User's Guides.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a modified device and the "Clinical Testing" section explicitly states "No clinical testing was conducted," the document does not contain a typical table of performance acceptance criteria (e.g., accuracy, precision) and reported device performance from new clinical studies.
Instead, the primary "acceptance criteria" for this specific 510(k) submission are related to the safety and effectiveness of the modifications compared to the predicate device. The document implies that the device had already met performance criteria in its original K102037 submission.
The "Non-Clinical Testing" section describes the evaluation of the modifications:
| Acceptance Criteria Category | Specific Criteria (Implicitly met through comparative testing) | Reported Device Performance |
|---|---|---|
| Disinfection Efficacy | The device, when cleaned with the additionally recommended disinfectants, must remain safe and effectively inactivated viruses. | "Disinfection (viral inactivation) and 'robustness' testing were done to qualify all recommended disinfection solutions. Results demonstrate substantial equivalence to the original (predicate) device." |
| Robustness after Disinfection | The device's performance must not be adversely affected by repeated disinfections using the recommended solutions. | "Disinfection (viral inactivation) and 'robustness' testing were done to qualify all recommended disinfection solutions. Results demonstrate substantial equivalence to the original (predicate) device." |
| General Performance (unchanged) | The underlying blood glucose measurement performance (accuracy, precision, etc.) of the device remains substantially equivalent to the predicate device. | "The modified AutoSure Voice II and AutoSure Voice II Pro Blood Glucose Monitoring Systems are identical to the original (predicate) system other than a) separation of the self-testing and professional usage claims into two products and b) the recommendation of four additional disinfectants in the User's Guides." "Testing showed that the modified AutoSure Voice II and AutoSure Voice II Pro Blood Glucose Monitoring Systems are substantially equivalent to the original (predicate) system." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified in the provided document for the disinfection and robustness testing.
- Data Provenance: The testing was "Non-Clinical," meaning laboratory testing. There's no indication of patient data or country of origin mentioned for this specific K150396 submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for the non-clinical disinfection and robustness testing described. Ground truth for viral inactivation studies would typically involve laboratory standards and analytical methods, not human expert consensus.
4. Adjudication Method for the Test Set
Not applicable for the non-clinical disinfection and robustness testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document explicitly states: "No clinical testing was conducted." This type of study would be clinical.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to a Blood Glucose Monitoring System, which is a device for physical measurement, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply in the context of typical AI device evaluation. The device itself performs the measurement.
7. The Type of Ground Truth Used
For the non-clinical disinfection and robustness testing, the "ground truth" would be established through:
- For Disinfection: Laboratory standards for viral inactivation (e.g., demonstrating reduction in viral load by a certain log factor).
- For Robustness: Pre-defined performance specifications for the meter that must be maintained after undergoing repeated disinfection cycles. This would likely involve comparing measurements against a reference method or validated control solutions.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The submission focuses on hardware and disinfectant compatibility.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 14, 2015
APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE MANAGER OF QUALITY ASSURANCE DEPARTMENT NO. 7 LI-HSIN ROAD V, HSINCHU SCIENCE PARK HSINCHU, 30078, CHINA
Re: K150396
Trade/Device Name: AutoSure Voice II Blood Glucose Monitoring System AutoSure Voice II Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: September 11, 2015 Received: September 14, 2015
Dear Hsue-Mei Lee:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF FREALTH AND HUMMA SERVICESIndications for UseFood and Drug Administration | Form Approved: OMB No. 0910-0120See PRA Statement below.xpiration Date: January 31, 2017 | |
|---|---|---|
| 510(k) Number (if knownR150396 | ||
| AutoSure Voice II Blood Glucose Monitoring SystenDevice Name | ||
| Indications for Use (Describe | ||
| changing rapidy). It is not intended for the disensis or screening of disbetes or for neonatal useassets and forme as an is to moring blood glucoses nellifits. This system is for single-paties instto assist visually impared users. It is intended for self-testing outside the by beadly withThe AutoSure Voice II Blood Glucose Monitoring System is intended for the quartifative measurement of glucose in | only and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is notfresh cary whole blood samples drawn the fingerting, forsearm, or palm. The more includes voice finestonality | |
| messure glucose in capillary whole blood taken from fingertips, palm, or forcarm | The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II Blood Glucose Meter to quantititively | |
| Type of Use (Select one or both, as applicable) | I Prescription Use (Part 21 CFF 801 Subpart D | X Over-The-Counter Use (21 CFR 801 Suppart C |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | ||
| in setting so not of the Personice of the Pages work Peduction Act of the | ||
| of this information collection, including suggestions for reducing this purden, to:WO WANT A SERIE YOUR CONTENT FOR THE PROFILE ADDRESS BELLO | time to reviews instructions, sestime data sources, gather and manufacturer in theand review the collection of information. Send comments regarding of any other aspectde on the senod served subor en established in the series and the mit not not not not not not only of the | |
| PRASISTIf@fdg.hhs.gooPaperwork Reduction Act (PRA) StateOffice of Chief Information OfficerFood and Drug AdministrationDepartment of Health and Human Services | ||
| "," be genery my no conduct or sponsor, and a person is not respond to, a collection ofinformation unless it displays a currently valid OMB number." | ||
| FOR FOR FOR 3888 (8114 | Page 1 of 1 | PSC Publishing Services (101) 443-6740ਜਤੀ ਹੈ |
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| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K150396 |
|---|---|
| Device Name | AutoSure Voice II Pro Blood Glucose Monitoring System |
| Indications for Use (Describe) | The AutoSure Voice II Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. The meter includes voice functionality to assist visually impaired users. It is intended for multiple-patient use in professional healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus. This system should only be used with single-use auto-disabling lancing devices. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use.The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice II Pro Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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510(k) Summary
| Submitter | Hsue-mei LeeManager of Quality Assurance DepartmentApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science Park, Hsinchu, 30078,CHINA (TAIWAN)email: hsue-mei@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302 |
|---|---|
| Contact Person | Hsue-mei LeeManager of Quality Assurance DepartmentApex BioTechnology Corp.No. 7, Li-Hsin Road V, Hsinchu Science Park, Hsinchu, 30078,CHINA (TAIWAN)email: hsue-mei@apexbio.comPhone: 011-886-3-5641952FAX: 011-886-3-5678302 |
| Date Prepared | October 12, 2015 |
| Trade Names | AutoSure Voice II Blood Glucose Monitoring SystemAutoSure Voice II Pro Blood Glucose Monitoring System |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | CGA, NBW |
| Predicate Device | AutoSure Voice II Blood Glucose Monitoring System and AutoSure BloodGlucose Test Strips (K102037) |
| Device Description | The AutoSure Voice II Blood Glucose Monitoring System consists of theAutoSure Voice II Meter and AutoSure Blood Glucose Test Strips. It is usedfor testing of blood glucose by self-testers at home. The AutoSure Voice IIPro Blood Glucose Monitoring System consists of the AutoSure Voice II ProMeter and AutoSure Pro Blood Glucose Test Strips. It is used for testing ofblood glucose by professional testers in healthcare facilities. The AutoSureVoice II and AutoSure Voice II Pro systems are identical other than trade namesand details of product labeling. |
| The AutoSure Voice II Blood Glucose Monitoring System is intended for the | |
| quantitative measurement of glucose in fresh capillary whole blood samples drawn | |
| from the fingertips, forearm, or palm. The meter includes voice functionality to assist | |
| visually impaired users. It is intended for self-testing outside the body (in vitro | |
| diagnostic use) by people with diabetes at home as an aid to monitoring blood glucose | |
| levels in diabetes mellitus. This system is for single-patient use only and should not be | |
| shared. Alternative site testing should be done only during steady-state times (when | |
| glucose is not changing rapidly). It is not intended for the diagnosis or screening of | |
| diabetes or for neonatal use. | |
| The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II | |
| Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken | |
| from fingertips, palm, or forearm. | |
| Intended Use | The AutoSure Voice II Pro Blood Glucose Monitoring System is intended for thequantitative measurement of glucose in fresh capillary whole blood samples drawnfrom the fingertips, forearm, or palm. The meter includes voice functionality to assistvisually impaired users. It is intended for multiple-patient use in professionalhealthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus.This system should only be used with single-use auto-disabling lancing devices.Alternative site testing should be done only during steady-state times (when glucose isnot changing rapidly). It is not intended for the diagnosis or screening of diabetes or forneonatal use.The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice IPro Blood Glucose Meter to quantitatively measure glucose in capillary whole bloodtaken from fingertips, palm, or forearm. |
| Comparison ofTechnologicalCharacteristics | The modified AutoSure Voice II and AutoSure Voice II Pro Blood Glucose MonitoringSystems are identical to the original (predicate) system other than a) separation of theself-testing and professional usage claims into two products and b) therecommendation of four additional disinfectants in the User's Guides. |
| Non-ClinicalTesting | Disinfection (viral inactivation) and "robustness" testing were done to qualify allrecommended disinfection solutions. Results demonstrate substantial equivalence tothe original (predicate) device. |
| Clinical Testing | No clinical testing was conducted. |
| Conclusion | Testing showed that the modified AutoSure Voice II and AutoSure Voice II Pro BloodGlucose Monitoring Systems are substantially equivalent to the original (predicate)system. |
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510(k) Summary (Continued)
§ 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.