TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM

K123087 · Tyson Bioresearch, Inc. · NBW · Jun 18, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123087
• Device Name: TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONBIO AC500 AC800 PRO BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Tyson Bioresearch, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 18, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TysonBio AC500 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 AC500 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The TysonBio AC500 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 AC500 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 AC500 Test Strips are for use with the TysonBio AC500 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The TysonBio AC500/AC800 Control Solutions is for use on the TysonBio AC500 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.

Device Story

System comprises glucose meter, test strips, and control solutions. Operates via electrochemical biosensor technology using glucose oxidase; measures glucose in 0.5uL capillary blood samples within 5 seconds. Meter performs auto-coding upon strip insertion. AC800/AC800 Pro models include voice guidance (not for vision-impaired). Used by patients at home or professionals in clinical settings to monitor diabetes control. Results displayed on meter; used by patients/providers to adjust diabetes management. Benefits include rapid, quantitative glucose monitoring to aid glycemic control.

Clinical Evidence

Performance evaluated in laboratory and clinical settings by healthcare professionals and lay users. Studies confirmed system accuracy and performance meet intended use requirements. No specific numerical clinical metrics (e.g., MARD, bias) provided in summary.

Technological Characteristics

Electrochemical biosensor using glucose oxidase. Hematocrit range 20-60%. Sample volume 0.5uL. Measurement range 20-600 mg/dL. Auto-coding via strip insertion. Powered by two AAA batteries. Connectivity via USB protocol. Memory capacity 500 results. Features include hypoglycemic/hyperglycemic alarms and meal flagging.

Indications for Use

Indicated for the quantitative measurement of glucose in capillary whole blood as an aid in monitoring the effectiveness of diabetes control programs.

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.

Predicate Devices

• TysonBio AC100 Blood Glucose Monitoring System (K101543)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K123087

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) Tyson Bio AC100 Blood Glucose Monitoring System (k101543).

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 (labeling changes are permitted as long as they do not affect the intended use).

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

- Name changes from TysonBio AC100 Blood Glucose Monitoring system to TysonBio AC500, AC500 Pro, AC800 and AC800 Pro Blood Glucose Monitoring Systems
- Minor outer design changes include:
- Operational button shape and position,
- Embedded color changes of casing and buttons
- Oval shape verses egg shape
- The addition of a backlit display on the AC800 models
- Remove voice function from AC500 models
- The hematocrit range change to 20% - 60% from 35-55% utilizing a modification in the applied voltage pulse frequency specifications, while using the same the final stage signal voltage and amperometric method.

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.

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# 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.

The validation protocols were adequate to address the identified causes of hazards identified in the Risk analysis (FMEA).

The devices consist of both single-patient use and multiple-patient use. Disinfection efficacy studies were performed on the materials comprising the meter and lancing device by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Cavicide Surface Disinfectant (EPA Registration #46781-6). Robustness studies were also performed by the sponsor demonstrated that there was no change in performance or in the external materials of the meter after 36500 cleaning and disinfection cycles, using Cavicide Surface Disinfectant designed to simulate cleaning and disinfection 20 times a day, over 5 years of device use. The sponsor also demonstrated that there was no change in performance or in the external materials of the lancing device for single-patient use after 7300 cleaning and disinfection cycles designed to simulate cleaning and disinfection 4 times a day, over 5 years of device use. Labeling has been reviewed for adequate instructions for the validated cleaning and disinfection procedures.