GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM

K141829 · Ceragem Medisys, Inc. · NBW · Sep 24, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141829
• Device Name: GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Ceragem Medisys, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 24, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The GlucoVitaal H1A 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 fingertip, forearm, upper arm, palm, thigh, or calf. The GlucoVitaal H1A Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The GlucoVitaal H1A 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 controls. The GlucoVitaal H1A Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. The GlucoVitaal H1A Blood Glucose Test Strips are for use with the GlucoVitaal H1A Blood Glucose Test Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, forearm, upper arm, palm, thigh, or calf. The GlucoVitaal H1A Glucose Control Solution is for use with the GlucoVitaal H1A Blood Glucose Test Meter and Test strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.

Device Story

System measures glucose in capillary whole blood via amperometric test strips containing FAD-GDH enzyme. User applies 0.5 uL blood sample to strip inserted into meter; meter displays quantitative glucose result in 5 seconds. Designed for single-patient home use; supports alternative site testing during steady-state glucose levels. Includes control solutions for quality verification. Meter stores 1000 results with date/time. No coding required. Provides diabetes management data to patients to monitor treatment effectiveness.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technical specifications to the predicate device.

Technological Characteristics

Electrochemical glucose biosensor; non-coding meter architecture; software-controlled measurement; compatible with proprietary test strips and control solutions; validated for 1825 cleaning/disinfection cycles using Caviwipes.

Indications for Use

Indicated for single-patient use for the quantitative measurement of glucose in capillary whole blood from the fingertip, palm, or forearm to monitor the effectiveness of diabetes control.

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

• CERA-CHEK I070 Blood Glucose Monitoring System (k131727)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k141829

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.) k131727, CERA-CHEK I070 Blood Glucose Monitoring System.

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 the following items:

i. Changing the name of the test system: The name of submitter's previously cleared test system (k131727) is the "CERA-CHEK I070 Blood Glucose Monitoring System", while the subject device is called the "GlucoVitaal HIA Blood Glucose Monitoring System". The name of the meter has been changed to "GlucoVitaal H1A Blood Glucose Test Meter"; the name of the test strips have been changed to "GlucoVitaal H1A Blood Glucose Test Strips"; the names of the control solutions have been changed to "GlucoVitaal H1A Glucose Control Solution 1" and "GlucoVitaal H1A Glucose Control Solution 2". The name of the data management system has been changed to the "GlucoVitaal H1A Diabetes Management Software".

ii. Making the meter non-coding through modifications to manufacturing specifications specific to the GlucoVitaal H1A BGMS. This also involves a software change to eliminate the code-setting function of the meter.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics (dimensions, weight), device performance and specifications.

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

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

{1}

Page 2 of 2

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.

The GlucoVitaal H1A Blood Glucose Monitoring System is intended for single patient use. Disinfection efficacy studies were performed for the predicate device (k131727, CERA-CHEK 1070 Blood Glucose Monitoring System) by an outside commercial testing laboratory and demonstrated complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Metrex Research Corporation Caviwipes (EPA Registration # 46781-8). Robustness studies also performed for the predicate device demonstrated that there was no change in performance or external materials of the meter after 1825 cleanings and 1825 disinfection steps with Metrex Research Corporation Caviwipes. The robustness studies were designed to simulate 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.