EOCENE SYSTEM

K090712 · Infopia Co, Ltd. · NBW · Oct 2, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090712
• Device Name: EOCENE SYSTEM
• Applicant: Infopia Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 2, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The GLUCOLAB™ Diabetes Monitoring System and EOCENE™ System is used for the quantitative measurement of glucose level in capillary 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 GLUCQLAB™ System and EOCENE'M System is not to be used for diagnosis, screening of diabetes or for neonatal use. The GLUCOLAB™ System and EOCENE™ System are 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™ control is used with GlucoLab™ Brand System to check that the meter and test strips are working together as a system and that you are performing the test correctly

Device Story

Eocene™ Glucose Telecommunication system acts as a data management accessory for GlucoLab™ or Eclipse™ Diabetes Monitoring Systems. The system consists of a cradle, DC 5V adapter, and phone line connection. It functions by transmitting blood glucose data from the monitoring meter to a database server via a phone line. Data is subsequently accessible to patients and healthcare professionals via the Eocene Secure website. The system is intended for use in home and clinical settings to facilitate remote monitoring of diabetes management effectiveness. By enabling regular data uploads, the system allows providers to review patient glucose trends, potentially improving clinical decision-making and diabetes management outcomes.

Clinical Evidence

Bench testing only; design control activities and verification/validation performed to assess impact of telecommunication modification; results met predetermined acceptance criteria.

Technological Characteristics

System includes Eocene cradle, DC 5V adapter, and phone line interface. Connectivity is via phone line to a remote database server. Software-based data transmission. No specific materials or energy standards cited.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from the fingertip for home use by individuals with diabetes to monitor glycemic control. Not for neonatal use or diabetes diagnosis/screening.

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

• GlucoLab™ Blood Glucose Monitoring System (K051285)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k090712

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the EOCENE SYSTEM:

1. The name and 510(k) number of INFOPIA CO., LTD's previously cleared device, GLUCOLAB Blood Glucose Monitoring System, cleared under k051285. (For a preamendments device, a statement to this effect has been provided.)
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.
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 the addition of glucose telecommunication to the GLUCOLAB system.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and 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.