RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110

K081450 · Bionime Corporation · NBW · Sep 11, 2008 · Clinical Chemistry

Device Facts

• Record ID: K081450
• Device Name: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110
• Applicant: Bionime Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 11, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Rightest Blood Glucose Monitoring System is intended for in vitro diagnostic use (outside of body). It is indicated to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management. The glucose concentration is measured with quantitative capillary whole blood from the fingertip, palm, and forearm by using Rightest Blood Glucose Monitoring System. This device is not intended for testing neonate blood samples.

Device Story

Rightest Blood Glucose Monitoring System (GM110) measures glucose concentration in fresh capillary whole blood; utilizes meter, test strips, control solutions, and lancing device. Principle of operation: amperometry using glucose oxidase (Aspergillus niger) and potassium ferricyanide mediator on noble metal electrodes. User applies blood sample (1.4 uL) to test strip; meter provides quantitative result in 8 seconds. Used by patients at home or healthcare professionals in clinical settings. Output displayed on meter; aids diabetes management decisions. System provides plasma-equivalent results.

Clinical Evidence

Clinical study evaluated alternative site testing (fingertip, palm, forearm) against Olympus AU2700 plasma reference. Sample size: 164 tests per site. Results showed high correlation (r=0.990 to 0.991) and similar slopes (0.95-0.98) and intercepts (2.13-9.80) across all sites. Bench testing confirmed precision, linearity, interference, and hematocrit range (30-55%).

Technological Characteristics

Electrochemical blood glucose meter; manual coding mechanism; mechanical housing; internal memory storage. Fundamental scientific technology consistent with predicate device.

Indications for Use

Indicated for professional healthcare personnel or diabetics at home to measure glucose concentration in capillary whole blood from fingertip, palm, or forearm for diabetes management. Contraindicated for neonate blood samples.

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

• Rightest Blood Glucose Monitoring System (K042678)
• Rightest Blood Glucose Monitoring System (K053635)
• Rightest Blood Glucose Monitoring System (K062567)

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 K081450

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.) k062567
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. Manual coding of meter added (compared to a code key in the predicate)
B. An engineering change in the mechanical appearance.
C. A decrease in memory.

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.