StatStrip Xpress 2 Glucose Hospital Meter System

K163490 · Nova Biomedical Corporation · PZI · Jan 6, 2017 · Clinical Chemistry

Device Facts

• Record ID: K163490
• Device Name: StatStrip Xpress 2 Glucose Hospital Meter System
• Applicant: Nova Biomedical Corporation
• Product Code: PZI · Clinical Chemistry
• Decision Date: Jan 6, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. The StatStrip Xpress 2 Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

Device Story

StatStrip Xpress 2 Glucose Hospital Meter System; point-of-care blood glucose monitoring; used in hospital settings by healthcare professionals. Device measures glucose levels in capillary, venous, and arterial whole blood. Modification involves lowering operating temperature range from 15°C to 5°C; software updated to adjust temperature error threshold accordingly. Device remains substantially equivalent to predicate; fundamental scientific technology unchanged. Supports multiple-patient use; validated for disinfection against Hepatitis B virus using Clorox Germicidal Wipes.

Clinical Evidence

Bench testing only. Verification activities performed to assess impact of temperature range modification and software update. Disinfection efficacy previously validated (k150461) for multiple-patient use, demonstrating inactivation of Hepatitis B virus and material integrity over 10,950 cleaning/disinfection cycles.

Technological Characteristics

Handheld glucose meter; electrochemical sensing principle. Modification: operating temperature range extended to 5°C (previously 15°C). Software updated to reflect new temperature error threshold. Device validated for multiple-patient use with specified disinfection protocols.

Indications for Use

Indicated for quantitative glucose determination in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonate heel stick specimens in hospital and professional healthcare settings. Not for neonate cord blood. Not for diabetes screening; indicated for dysglycemia determination.

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

• Statstrip Xpress 2 Glucose Hospital Meter System (k152986)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K163490

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.) Statstrip Xpress 2 Glucose Hospital Meter System - k152986
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:

- Changing the lower limit of the operating temperature range from 59°F (15°C) to 41°F (5°C)
- Modifying the software for the temperature error code from displaying the error when the operating temperature is less than 15°C to displaying the error when the operating temperature is less than 5°C.

Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and specificaitons

4. 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 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.

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# Infection Control Studies:

The StatStrip Xpress 2 Glucose Hospital Meter System is intended for multiple-patient use. Disinfection efficacy studies were previously performed (k150461) on the external materials of the meter by an outside commercial testing service and demonstrated complete inactivation of live Hepatitis B virus with Clorox Germicidal Wipes, EPA registration # 67619-12). The sponsor also demonstrated that there was no change in performance or in the external materials of the meter after 10,950 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) to simulate 3 years of device use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

This device was cleared after the FDA issued final guidance documents for prescription use blood glucose monitoring systems (BGMS) and over-the-counter use blood glucose monitoring systems (SMBG).