FORA POCT MANAGMENT SYSTEM

K111029 · Taidoc Technology Corporation · NBW · Jul 1, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111029
• Device Name: FORA POCT MANAGMENT SYSTEM
• Applicant: Taidoc Technology Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The FORA POCT Management System is a data management software and designed for using in hospital or health institute environment. Patient historical data transmitted is able to be reviewed and analyzed in this system. The FORA POCT Management System may not be used as a substitute for direct medical intervention or emergency care. Interpretation of the information collected and transmitted requires clinical judgment by an appropriate healthcare professional.

Device Story

FORA POCT Management System is data management software for hospital/clinical environments. Inputs: historical blood glucose test data transmitted from meters. Processing: organizes data into graphs and summary tables for quality control, stock control, meter settings, and operator/unit management. Output: visual reports and summaries for healthcare professionals. Usage: clinicians review analyzed data to support health management and clinical decision-making. Benefits: enables effective management of POCT data and quality control, facilitating improved clinical decision-making through historical trend analysis.

Clinical Evidence

No clinical data provided. The submission relies on bench testing, including validation of interoperability between the management system and the FORA POCT S10 meter, functionality system testing, mass data/multiple device upload testing, and integration testing with Laboratory Information Systems (LIS).

Technological Characteristics

Data management software hosted on an Intranet secure server. Requires PC with 2.0 GHz processor, 512MB RAM, and USB 2.0 connectivity. Operates via Microsoft Internet Explorer (6.0+) with ActiveX. Data transmission is wired (USB). Includes database management for glucose results, QC, and inventory. No specific materials or sterilization applicable as it is software.

Indications for Use

Indicated for use in hospital or health institute environments to review and analyze historical patient data transmitted from blood glucose meters. Requires clinical judgment by healthcare professionals for interpretation; not for emergency care or as a substitute for direct medical intervention.

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

• AtLast® Data Management Software (DMS) (K010605)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k111029

B. Purpose for Submission:
New 510(k) for diabetes data management software accessory for use with compatible glucose meters such as the FORA POCT S10 Blood Glucose Monitoring System (K092688)

C. Measurand:
Whole blood glucose

D. Type of Test:
Diabetes data management system

E. Applicant:
TaiDoc Technology Corporation

F. Proprietary and Established Names:
FORA POCT Management System

G. Regulatory Information:
1. Regulation section:
21CFR Sec.-862.1345-Glucose test system.
21CFR Sec.-862.2100 - Calculator/data processing module for clinical use.
2. Classification:
Class II and I respectively
3. Product code:
NBW - System, Test, Blood Glucose, Over the Counter
JQP-Calculator/Data Processing Module, for Clinical Use
4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
See indication(s) for use below
2. Indication(s) for use:
The FORA POCT Management System is a data management software and designed for using in hospital or health institute environment. Patient historical data transmitted is able to be reviewed and analyzed in this system.

The FORA POCT Management System may not be used as a substitute for direct medical intervention or emergency care. Interpretation of the information

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collected and transmitted requires clinical judgment by an appropriate healthcare professional.

3. Special conditions for use statement(s):
Prescription use

4. Special instrument requirements:
FORA POCT S10 Blood Glucose Monitoring System

I. Device Description:
The role of FORA POCT Management System is data management software that runs on a common Intranet secure server platform. The system assists healthcare professionals to store, review, analyze and evaluate the historical data. Those data are transmitted from the device’s memory to the system via cable connections.

The FORA POCT Management System is designed for use in hospital or heath care facility. This system provides comprehensive database management including test results of blood glucose measurements and quality controls, stock management of test strips and control solutions, meter configurations, information of patients, operators and facility administrators along with statistical graphs, charts and other helpful tools.

J. Substantial Equivalence Information:
1. Predicate device name(s):
AtLast® Data Management Software (DMS)
2. Predicate 510(k) number(s):
K010605
3. Comparison with predicate:

| Item | Proposed device | Predicate (k010605) |
| --- | --- | --- |
| Brand name | FORA POCT Management System | AtLast® Data Management Software (DMS) |
| Submitter | TaiDoc Technology Corporation | Amira Medical |

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| Intended Use | The FORA POCT Management System is data management software. Patient historical data transmitted is able to be reviewed and analyzed in this system.
The FORA POCT Management System may not be used as a substitute for direct medical intervention.
Interpretation of the information collected and transmitted requires clinical judgment by an appropriate healthcare professional. | Same |
| --- | --- | --- |
| Intended users | Clinical users | Same |
| Site of use | Clinical settings | Same |
| Data collection software | Proprietary software | Same |
| Communication method with management system | Via broadband intranet connection | Same |
| Communication method with Meter | A USB cable is used for meter to connect to PC, and software. | A custom interface cable is used for meter to connect to PC, and software. |
| Types of Test Data which is applied | Glucose levels | Same |
| Communications protocol | Proprietary | Same |
| Data Presentation | By Reports, Graphs and Charts | Same |

K. Standard/Guidance Document Referenced (if applicable):
None were referenced

L. Test Principle:
FORA POCT Management System is an accessory to compatible meters, which use specific test principles, such as the FORA POCT S10 Blood Glucose Monitoring System (k092688)

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M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Presented in k092688
b. Linearity/assay reportable range:
Presented in k092688
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Presented in k092688
d. Detection limit:
Presented in k092688
e. Analytical specificity:
Presented in k092688
f. Assay cut-off:
Presented in k092688

2. Comparison studies:
a. Method comparison with predicate device:
Presented in k092688
b. Matrix comparison:
Not Applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not Applicable

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Presented in k092688

N. Instrument Name:

FORA POCT Management System

O. System Descriptions:

1. Modes of Operation:
Microsoft Internet Explorer 6.0, 7.0, 8.0 or later versions (with ActiveX installation allowed)
*Personal computer with 2.0 GHz or higher processor clock speed recommended
*Higher than 512MB of RAM recommended
*Monitor with at least 800x600 pixels resolution
*Intranet accessibility with at least 1Mbps bandwidth

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*USB 2.0 port and USB cable

Does the applicant's device contain the ability to transmit data to a computer, webserver, or mobile device?:

Yes ☐ X or No ☐

Does the applicant's device transmit data to a computer, webserver, or mobile device using wireless transmission?:

Yes ☐ or No ☐ X

2. Software:

FDA has reviewed applicant's Hazard Analysis and software development processes for this line of product types:

Yes ☐ X or No ☐

3. Specimen Identification:

Glucose test results are identified from registered meters according to different items such as operator ID (bar-coded), patient ID (bar-coded), meter ID, strip ID, and test date/time.

4. Specimen Sampling and Handling:

Not Applicable

5. Calibration:

Not Applicable

6. Quality Control:

The system contains a Quality Control program that allows the administrator to query, review and comment on QC data from the registered meters, according to different items, such as operators, meters, strips and control solution. In addition to the comment codes which operators may note from meters, the system displays the distribution graphs plotted with means and bounds and allows adding review comments for administrative functions.

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P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:

The sponsor provided test results for the validation of the interoperability of the FORA POCT Management System and FORA POCT S10 Blood Glucose meter for: functionality system test, and mass data and multiple devices upload, plus interoperability with Laboratory Information Systems (LIS).

Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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