StatStrip Xpress Glucose Hospital Meter System

K161856 · Nova Biomedical Corporation · PZI · Nov 15, 2016 · Clinical Chemistry

Device Facts

• Record ID: K161856
• Device Name: StatStrip Xpress Glucose Hospital Meter System
• Applicant: Nova Biomedical Corporation
• Product Code: PZI · Clinical Chemistry
• Decision Date: Nov 15, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The StatStrip Xpress 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 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 whole blood 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 Glucose Hospital Meter System; point-of-care blood glucose monitoring device for hospital use. Modification: expansion of operating temperature range from 15°C-40°C to 5°C-40°C. Input: blood sample via test strip; electrochemical measurement. Output: glucose concentration displayed on meter. Operation: healthcare professionals perform testing; device provides rapid results for clinical decision-making. Modification involves software update to temperature error threshold; hardware remains unchanged. Benefit: increased utility in colder clinical environments.

Clinical Evidence

Bench testing only. Verification activities performed to confirm device performance within the new operating temperature range (5°C to 15°C). Disinfection efficacy and durability testing (10,950 cycles) previously established in K150461.

Technological Characteristics

Handheld electrochemical biosensor; glucose oxidase reagent; 1.2 μL sample volume; 6-second result time; 5°-40°C operating range; 20-65% hematocrit range; 3V lithium coin cell power; LCD display; 400-test memory; non-volatile data storage.

Indications for Use

Indicated for point-of-care, in vitro diagnostic, multiple-patient use for quantitative glucose determination in capillary finger stick, venous whole blood, arterial whole blood, and neonate heel stick/arterial specimens in hospital and professional healthcare settings. Not for neonate cord blood or diabetes screening; indicated for dysglycemia management.

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 Glucose Hospital Meter System (K150461)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K161856

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 Glucose Hospital Meter System - k150461

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.

Infection Control Studies:

The StatStrip Xpress 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

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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). However, the recommendations in the guidance documents were not followed for this device since the submission was received prior to the finalization of the guidance documents.

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