(28 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components or capabilities.
No
The device is a diagnostic tool used to measure blood glucose levels, which aids in monitoring the effectiveness of diabetes control. It does not provide therapy or treatment itself.
Yes
Explanation: The device is described as an "in vitro diagnostic use" system intended "as an aid to monitor the effectiveness of diabetes control," which directly falls under the definition of a diagnostic device. It quantifies glucose levels to provide information for managing a medical condition.
No
The device description explicitly lists hardware components such as a meter, batteries, carrying case, lancing device, lancets, and control solution.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Testing is done outside of the body (in vitro diagnostic use)."
The "Device Description" section also reiterates this: "The WaveSense Jazz Test Strips are for in vitro diagnostic (outside of the body) use only."
N/A
Intended Use / Indications for Use
The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The WaveSense Jazz Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device lancets, control solution and instructions for use. Test Strips are necessary for testing but are sold separately.
The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertips, palm or forearm. The WaveSense Jazz Test Strips are for in vitro diagnostic (outside of the body) use only. The WaveSense Jazz System is not intended for use with neonates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood from the finger stick, palm and/or forearm.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
At home (over the counter (OTC)) by persons with diabetes.
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)
Activities to verify and validate the modification and robustness testing, firmware functional testing and usability engineering evaluations.
Based on the verification and validation results, the candidate WaveSense Jazz Blood Glucose Monitoring System is substantially equivalent to the predicate WaveSense Jazz Blood Glucose Monitoring System (K072413).
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.
Not Found
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).
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" stacked on top of each other.
June 6, 2024
AgaMatrix Dave Valcourt Regulatory Affairs Manager 7C Raymond Ave Salem, New Hampshire 03079
Re: K241304
Trade/Device Name: WaveSense Jazz Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: May 9, 2024 Received: May 9, 2024
Dear Dave Valcourt:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joshua Balsam -S
Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
K241304 Device Name
WaveSense Jazz Blood Glucose Monitoring System
Indications for Use (Describe)
The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Prepared on: 2024-06-04
Contact Details
21 CFR 807.92(a)(1)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
| Applicant Name | AgaMatrix |
|---|---|
| Applicant Address | 7C Raymond Ave Salem NH 03079 United States |
| Applicant Contact Telephone | 603-328-6079 |
| Applicant Contact | Dave Valcourt |
| Applicant Contact Email | dvalcourt@agamatrix.com |
21 CFR 807.92(a)(2)
| Device Trade Name | WaveSense Jazz Blood Glucose Monitoring System |
|---|---|
| Common Name | Blood Glucose Monitoring System |
| Classification Name | System, Test, Blood Glucose, Over the Counter |
| Regulation Number | 862.1345 |
| Product Code(s) | NBW |
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K072413 | WaveSense Jazz Blood Glucose Monitoring System | NBW |
21 CFR 807.92(a)(4)
The WaveSense Jazz Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device lancets, control solution and instructions for use. Test Strips are necessary for testing but are sold separately.
The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertips, palm or forearm. The WaveSense Jazz Test Strips are for in vitro diagnostic (outside of the body) use only. The WaveSense Jazz System is not intended for use with neonates.
21 CFR 807.92(a)(5)
The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at
blood from the fingerstick, palm and/orforearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.
Indications for Use Comparison
The indications for use of the candidate device are the indications for use of the predicate device with the following changes: the candidate device is not indicated for prescription use and is not indicated for clinical use.
Technological Comparison
The candidate WaveSense Jazz BGMS has the same fundamental scientific technology as the predicate WaveSense Jazz BGMS. The differences between the candidate WaveSense Jazz BGMS and the predicate are the introduction of new colors on the top housing and the introduction of a new data management feature.
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Activities to verify and validate the modification and robustness testing, firmware functional testing and usability engineering evaluations.
Based on the verification and validation results, the candidate WaveSense Jazz Blood Glucose Monitoring System is substantially equivalent to the predicate WaveSense Jazz Blood Glucose Monitoring System (K072413).