HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM

K132862 · Infopia Co, Ltd. · NBW · Dec 12, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132862
• Device Name: HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Infopia Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 12, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device is intended for multiple-patient use.

Device Story

System measures glucose concentration in fresh capillary whole blood via electrical current generated in test strips; meter processes current to provide quantitative glucose reading. Used in professional healthcare settings by clinicians for multiple-patient monitoring. Includes meter, test strips, and control solutions. Modifications from predicate include prescription use claim, Patient ID function for result tracking, and updated strip cover graphics. Clinicians use output to assess diabetes control program effectiveness. Device validated for disinfection using CaviWipes (EPA 46781-8) to support multi-patient use.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed performance, functionality, and reliability. Disinfection study validated CaviWipes (EPA 46781-8) for 10,980 cycles, simulating 3 years of use, with no degradation in performance or external materials.

Technological Characteristics

In vitro diagnostic glucose test system. Amperometric sensing principle. Components: meter, test strips, control solutions. Supports multi-patient use with validated disinfection protocols. Features Patient ID function for result tracking.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertips, palm, hand, arm, forearm, calf, thigh) in professional healthcare settings to monitor diabetes control programs. Contraindicated for diabetes diagnosis, screening, or neonatal use. Alternative site testing restricted to steady-state glucose conditions.

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

• Healthpro TM Blood Glucose Test System (K113192)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k132862

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. k113192 - Healthpro 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).

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) to add an additional name to their cleared system: Healthpro Professional Blood Glucose Monitoring System, 2) adding a patient ID function, 3) a modification of the graphic design of the test strip cover. Specifically, the test strip was modified by changing the shape of the arrow indicating the direction to insert the test strip, and by changing the color from blue to silver, 4) an addition to the name of their cleared controls: Healthpro Professional Glucose Control Solution, and 5) the addition of validated cleaning and disinfection instructions for multiple-patient use to the labeling.

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

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
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.

5. 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

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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 sponsor's previously cleared device.

The device is intended for multiple-patient use. CaviWipes Disinfecting Towelettes (EPA registration #46781-8) were validated through disinfection efficacy studies demonstrating complete inactivation of hepatitis B (HBV) virus using materials comprising the meter. Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or in the external materials of the meter after 10,980 cleaning and disinfection cycles (one cycle includes one cleaning wipe plus one disinfecting wipe) to simulate 3 years of multiple-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.