GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110

K082417 · Arkray Factory USA, Inc. · CGA · Oct 21, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082417
• Device Name: GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110
• Applicant: Arkray Factory USA, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Oct 21, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The GLUCOCARD™ 01-mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body ( In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Device Story

GLUCOCARD™ 01-mini is a blood glucose monitoring system comprising a meter, test strips, and control solutions. It measures glucose levels in fresh capillary whole blood samples obtained from fingertips or palms. Used by patients at home or healthcare professionals in clinical settings, the device provides quantitative glucose readings to assist in diabetes management. The system functions as an in vitro diagnostic tool; it processes blood samples to provide immediate feedback on glucose concentration, enabling users to monitor the effectiveness of their diabetes control strategies.

Clinical Evidence

Clinical study conducted with persons with diabetes to evaluate system accuracy and ease of use. Analytical verification testing performed to evaluate precision, dynamic range, and linearity.

Technological Characteristics

System includes meter, test strips, and control solutions. Quantitative measurement of glucose in capillary whole blood. In vitro diagnostic device. Class II, 21 CFR 862.1345.

Indications for Use

Indicated for use by patients with diabetes for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip, palm, or forearm.

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

• Arkray Glucocard 01 (K073416)

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 k082417

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.) k073416 Arkray Glucocard 01.
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 reducing the size of the meter and adding memory functions. The size of outer casing and LCD screen were reduced. In addition, flags for pre and post meal results were added, 7 day result averaging was added, result memory was reduced from 360 to 50 results, and the number of tests from the battery was increased from 2000 to 3000.

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.