JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381

K083265 · Agamatrix, Inc. · NBW · Feb 3, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083265
• Device Name: JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
• Applicant: Agamatrix, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 3, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

AgaMatrix JAZZ Wireless™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. AgaMatrix JAZZ Wireless™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. AgaMatrix JAZZ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ Wireless 110 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. AgaMatrix WaveSense™ Control Solution is intended for use with the AgaMatrix JAZZ Wireless M Meter and AgaMatrix JAZZ Wireless Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Device Story

Portable, battery-operated blood glucose monitoring system; measures glucose in fresh capillary whole blood via test strips. Modification adds Bluetooth wireless capability for data upload to PC, replacing USB cable. Used by diabetics at home or clinicians in clinical settings. Provides quantitative glucose readings to assist in diabetes management. System includes meter, lancing device, lancets, control solution, and test strips.

Clinical Evidence

Bench testing only; validation protocols addressed hazards identified in System Risk analysis (FTA).

Technological Characteristics

Portable, battery-operated glucose meter. Connectivity: Bluetooth wireless for PC data upload. Standards: ISO 15197:2003, ISO 14971:2000, IEC 61010-1, IEC 61010-2-101, IEC 61000-4-3. Codeless technology.

Indications for Use

Indicated for use by patients with diabetes for the quantitative measurement of glucose in capillary whole blood.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k083265

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the Jazz Wireless Blood Glucose Monitoring System, Model 8000-03381:

1. The name and 510(k) number of Agamatrix Inc's previously cleared device, JAZZ Blood Glucose Monitoring System, cleared under k072413. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION (S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for a wireless feature (in addition to the existing USB cable) which enables users to upload data from the meter to a Bluetooth enabled PC.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.
5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.
6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

Comments – Validation Protocols were adequate to address the identified causes of hazards identified in the System Risk analysis (FTA)

revised: 8/1/03