GLUCO LAB AUTO CODING, MODEL IGM-0022

K091157 · Infopia Co, Ltd. · NBW · Nov 17, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091157
• Device Name: GLUCO LAB AUTO CODING, MODEL IGM-0022
• Applicant: Infopia Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 17, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GLUCOLAB Auto-coding™ Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings, including physician's office laboratories and point of care sites . The GLUCOLAB Auto-coding™ System provides plasma equivalent results. The GLUCOLAB Auto-coding™ System is not intended to be used with neonatal blood samples. The GLUCOLAB Auto-coding™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh. GLUCOLAB Auto-coding™ control is used with GLUCOLAB Auto-coding™ Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly. It is very important that you do control solution tests routinely to make sure you are getting accurate results. Control Solutions are sold separately.

Device Story

System measures glucose in whole blood samples; utilizes test strips and meter. Key feature: auto-coding function via code recognition band on test strip to prevent incorrect code matching. Used by patients at home or clinicians in point-of-care/office settings. Meter reads strip, processes glucose level, and displays plasma-equivalent results. Output aids diabetes management decisions. Control solutions verify system/strip functionality.

Clinical Evidence

Clinical performance evaluation conducted to validate consumer and professional accuracy. Results demonstrated substantial equivalence to the predicate device. Non-clinical verification and validation testing confirmed performance, functionality, and reliability met pre-determined pass/fail criteria.

Technological Characteristics

Modification from manual coding to auto-coding; physical appearance change. Fundamental scientific technology unchanged.

Indications for Use

Indicated for quantitative blood glucose measurement in patients with diabetes to monitor management effectiveness. Suitable for home, physician office, and point-of-care use. Not for use with neonatal blood samples. Testing sites include fingertip and alternate sites (forearm, upper arm, palm, calf, thigh).

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

• K051285

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 K091157

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.) k051285
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. Change physical appearance
B. Change from manual coding to auto-coding

Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics. Labeling changes were made in association with the above modification in the calibration section, expected value section and performance characteristics.

4. 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.

5. 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.