LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM

K140141 · Ceragem Medisys, Inc. · NBW · Jul 3, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140141
• Device Name: LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Ceragem Medisys, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 3, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The LabonaCheck® Gluppy Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The LabonaCheck® Gluppy Blood Glucose Monitoring System should not be used for the diagnosis or screening of diabetes or for neonatal use. The LabonaCheck® Gluppy Blood Glucose Test Strips are for use with the LabonaCheck® Gluppy Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

Device Story

System measures glucose in fresh capillary whole blood; utilizes test strips and meter. Blood applied to absorbent hole; drawn into reaction zone; glucose reacts with reagent (glucose oxidase/potassium ferricyanide). Meter uses amperometry via noble metal electrode to quantify glucose concentration. Used at home by patients with diabetes for self-monitoring. Output displayed on meter; provides quantitative glucose result (20-600 mg/dL) to aid in diabetes management. System includes meter, test strips, lancing device, lancets, battery, and carrying case.

Clinical Evidence

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

Technological Characteristics

Blood glucose meter; electrochemical sensing principle. Modifications: exterior test strip grip structure; automatic meter coding. Fundamental technology unchanged from predicate.

Indications for Use

Indicated for use by patients with diabetes for the quantitative measurement of glucose in capillary whole 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

• Labonacheck Glappy Blood Glucose Monitoring System (k102751)

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 k140141

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.) The predicate device Labonacheck Glappy Blood Glucose Monitoring System was cleared under k102751.

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. Test strip grip structure change. The "grip" refers to the exterior cassette where the test strip is housed. The strip itself remains the same.

b. Meter code setting change. Predicate device requires a setting step for using the built-in code in meter. The new device is automatically coded with the built in-code, no setting step is required.

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.