AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS

K102037 · Apex BioTechnology Corp. · CGA · Aug 13, 2010 · Clinical Chemistry

Device Facts

• Record ID: K102037
• Device Name: AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Aug 13, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AutoSure Voice Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, and forearm. The system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

System measures glucose in capillary whole blood samples; utilizes test strips inserted into meter. Features voice functionality for visually impaired users; includes autocoding feature for test strip calibration. Used by patients at home or healthcare professionals in clinical settings. Meter processes blood sample via test strip; provides quantitative glucose level output. Assists in monitoring Diabetes Mellitus; plasma-calibrated for lab result comparison.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements (21 CFR 820.30) to confirm performance characteristics of modified test strips and meter hardware. FMEA used to assess impact of modifications.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Features voice output for accessibility. Includes autocoding mechanism for test strip calibration. Plasma-calibrated. Software-controlled measurement.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from finger, palm, and forearm for diabetes management at home. Not for diabetes diagnosis, screening, or neonatal use.

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

• AutoSure Voice meter and test strips

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k102037

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.) AutoSure Voice Blood Glucose Monitoring System (k090043)

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:

A. Modified test strips with additional electrode tracks allowing auto-coding of lot-specific calibration information.

B. Modified test strip holder to accommodate modified test strip

C. The physical appearance of the meter has changed (i.e. three operating buttons relocated from side to the front of the device).

D. The name of the device has changed from "AutoSure Voice" to "AutoSure Voice II".

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, performance characteristics and Flesch-Kincaid readability assessment.

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: FMEA.

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.