NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM

K070960 · Nova Biomedical Corp. · CGA · Jul 11, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070960
• Device Name: NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
• Applicant: Nova Biomedical Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jul 11, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Nova StatStrip Xpress Glucose Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial, and neonate whole blood. It is indicated for use in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control. Nova StatStrip Glucose Test Strips are intended for use only with Nova StatStrip Glucose Hospital Meters for quantitative tests. The glucose meter is intended to quantitatively measure glucose (sugar) in whole blood. The Glucose Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatStrip Glucose Test Strips are for testing outside the body (in vitro diagnostic use only). Nova StatStrip Control Solutions is intended for use with Nova StatStrip Glucose Hospital Meters and Nova StatStrip Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Level 2, and Level 3). These solutions will be offered for sale separately from the meter. Nova StatStrip Glucose Linearity Kit solutions are used to check the linearity of Nova StatStrip Glucose Hospital Meter Systems. There are five levels of linearity solutions, (Level 2, Level 3, Level 4, and Level 5).

Device Story

Nova StatStrip Xpress Glucose Hospital Meter is a point-of-care diagnostic device for quantitative glucose measurement in whole blood (capillary, venous, arterial, neonate). System includes meter, test strips, control solutions, and linearity kits. Operates via electrochemical biosensor technology; test strips react with blood sample to produce electrical signal proportional to glucose concentration. Meter processes signal to provide plasma-equivalent glucose results. Used by healthcare professionals in clinical settings for diabetes management. Output displayed on meter screen for immediate clinical decision-making. Benefits include rapid, accurate bedside glucose monitoring, reducing need for central laboratory testing.

Clinical Evidence

No clinical data provided in the document; substantial equivalence based on bench testing and performance verification of the glucose measurement system.

Technological Characteristics

Glucose hospital meter. Modifications: reduced form factor, single-use battery, monochrome display, USB connectivity. Fundamental sensing technology unchanged from predicate. Design controls per 21 CFR 820.30 applied.

Indications for Use

Indicated for use as a glucose hospital meter for the measurement of glucose in 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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER k070960

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:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
Identified predicate: Nova Biomedical StatStrip Glucose Hospital Meter (k063821)

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 1) a reduction in size and weight, a reduction in the number of stored test results, a switch from a rechargeable to a single-use battery, a change from a color to a black and white display, the removal of alphanumeric data entry keys, a change in data transfer method from TCP/IP Ethernet to USB, and the removal of a bar code scanner.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device, including labeling, intended use, physical characteristics, electrical safety testing, software verification testing, and precision and linearity testing.

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.