ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM

K120183 · Broadmaster Biotech Corperation · NBW · May 11, 2012 · Clinical Chemistry

Device Facts

• Record ID: K120183
• Device Name: ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Broadmaster Biotech Corperation
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 11, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Advocate Redi-Code BMB-EA001S Blood Glucose Monitoring System is intended for single patient home use only.

Device Story

System comprises blood glucose meter, test strips, and control solutions; utilizes amperometric method to measure glucose concentration in fresh capillary whole blood. User applies blood sample to test strip; meter measures current proportional to glucose level; displays quantitative result. Designed for home use by single patient; includes speaking function for audio output. Provides data for monitoring diabetes control programs. Differences from predicate include housing color/material and addition of speaking instructions; core measurement technology and algorithm remain identical.

Clinical Evidence

Bench testing performed including precision, linearity, accuracy, and interference studies. Clinical evaluation included lay user assessment and alternate site testing performance. Speaking function evaluated for user convenience. Testing confirmed performance meets requirements and matches predicate.

Technological Characteristics

Blood glucose monitoring meter; includes speaking function; validated for 3000 cleaning/disinfection cycles; software modified to support audio output; intended for single-patient home use.

Indications for Use

Indicated for single-patient home use for blood glucose monitoring.

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

• Shepherd Blood Glucose Monitoring System (k102316)

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 k120183

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.) k102316 Shepherd 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:

A. Addition of the speaking function. The speaking function required: a. a software change and b. a labeling change
B. The name of the device has changed from "Shepherd Blood Glucose Monitoring System" to "Advocate Redi-Code BMB-EA001S"

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

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The Advocate Redi-Code BMB-EA001S Blood Glucose Monitoring System is intended for single patient home use only. CaviWipes™ Disinfecting Towelettes (EPA Reg. No. 46781-8) were validated demonstrating complete inactivation of live virus for use with the parent meter and parent lancing device. Robustness studies were performed on the Advocate Redi-Code BMB-EA001S meter demonstrating that there was no change in performance or in the external materials of the meter and lancing device after 3000 cleaning and disinfection cycles designed to simulate one cycle a day, over 5 years of single-patient use. The labeling has been revised for adequate instructions on the validated cleaning and disinfection procedures.