GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM

K032985 · Hmd Biomedical, Inc. · NBW · Oct 21, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032985
• Device Name: GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
• Applicant: Hmd Biomedical, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The GlucoLeader Enhance Self-Monitoring of Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. 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 a clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Device Story

System consists of glucose meter and bio-active electrode (test strip) containing glucose oxidase. Capillary blood sample drawn into strip via capillary action; glucose reacts with reagent to produce potassium ferrocyanide. Oxidation of ferrocyanide generates electrical current proportional to glucose concentration; meter converts current to glucose value. Used by patients (home) or healthcare professionals (clinical) to monitor diabetes control. Features include memory storage, date/time settings, and RS232 data download. Output displayed on LCD; informs clinical decision-making regarding diabetes management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control activities, risk analysis, and verification/validation of modifications.

Technological Characteristics

Glucose oxidase electrochemical biosensor. Meter dimensions: 95x60x18.5mm; weight: 70g. Power: 0.15V. Connectivity: RS232 interface for data download. Measuring range: 30-600 mg/dL. Hematocrit range: 30-50%.

Indications for Use

Indicated for self-monitoring of blood glucose levels in patients with diabetes.

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

• GlucoLeader™ Value Self-Monitoring of Blood Glucose System (K032985)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k032985

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.)
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 following:

a. GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System has two buttons to execute settings, memory and recall functions, and the GlucoLeader™ Value Self-Monitoring of Blood Glucose System doesn't have any buttons to execute these functions.
b. GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System can download its test result to a personal computer by RS232 interface, and the GlucoLeader™ Value Self-Monitoring of Blood Glucose System doesn't have this function.
c. GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System can calculate mean results within 7, 14, 21, and 28 days, and the GlucoLeader™ Value Self-Monitoring of Blood Glucose System doesn't have this function.

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.