SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277

K100701 · Biotest Medical Corp. · NBW · Apr 8, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100701
• Device Name: SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277
• Applicant: Biotest Medical Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 8, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Smartest Persona Blood Glucose Monitoring System, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains a speaking function that provides audible test results for users with low vision.

Device Story

System measures glucose in fresh capillary whole blood from finger or forearm; intended for diabetes management. Components include meter, test strips, control solutions, lancing device, and lancets. Meter features bilingual speaking function for low-vision users. Used by healthcare professionals or patients at home. Provides quantitative glucose results to aid diabetes control programs. Not for diagnosis or screening. Modifications from predicate include added backlight, updated error message (E_4), and altered physical form factor.

Clinical Evidence

Bench testing only; design control activities and risk analysis performed to validate modifications; no clinical data required for this device modification.

Technological Characteristics

Glucose oxidase-based electrochemical sensing. Includes backlight, bilingual audio output for low-vision users, and alternate site testing capability. Standalone meter.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from finger, palm, and forearm; for use by individuals with diabetes at home to monitor diabetes control; not for diabetes diagnosis/screening; not for use on neonates.

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

• SuperCheck 1 Blood Glucose Monitoring System (SuperCheck 1), Model 6268 (K091815)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k100701

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 Smartest Persona Blood Glucose Monitoring System:

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.) Biotest Medical Corp. SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM cleared under k091815.
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 addition of back light, name of memory error message, and outer case dimensions shape and size.
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.