DA01 BLOOD GLUCOSE MONITORING SYSTEM

K132338 · Delbio Incorporation · NBW · Oct 24, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132338
• Device Name: DA01 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Delbio Incorporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 24, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The DA01 Blood Glucose Monitoring System is intended for home use by a single person.

Device Story

DA01 Blood Glucose Monitoring System; modified to include USB-based data transmission to DiaLife Mini Management Software. Device inputs: blood glucose samples; outputs: glucose concentration readings; data transmission via USB to external software. Used in home settings by single patients. Modification involves software update for data connectivity; fundamental scientific technology remains unchanged. Benefits: enables patient data management and tracking via external software interface.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

System includes glucose meter, disposable electrochemical test strips, and PC-based software. Connectivity via USB for data transfer. Software is intended for data management and reporting.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood (finger/palm) by individuals with diabetes at home to monitor effectiveness of diabetes control. Not for diagnosis/screening of diabetes or testing of neonates. Alternate site testing restricted to steady-state glucose conditions.

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 (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K132338

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 Delbio's previously cleared device, k120866 DA01 Blood Glucose Monitoring System.
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 software modification to add USB-based data transmission from the DA01 blood glucose meter to the DiaLife Mini Management Software.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, 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.

The DA01 Blood Glucose Monitoring System is intended for home use by a single person. Disinfection studies were performed on the DA01 meter to determine the robustness of the meter to the recommended cleaning and disinfection protocol, and its effectiveness in preventing the spread of bloodborne pathogens, particularly hepatitis B virus (HBV). Super Sani-cloth germicidal disposable wipes manufactured by Professional Disposables International, Inc. (EPA Reg. No. 9480-4) were validated, demonstrating complete inactivation of live virus for use with the DA01 meter. The sponsor demonstrated

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that there was no change in performance or in the external materials of the DA01 meter after 260 cleaning and disinfection cycles to simulate an estimated one cleaning and disinfection cycles per week over 5 years of use at home by a single person. Labeling has been reviewed for adequate instructions on the validated cleaning and disinfection procedures.