HANDHELD BASE UNIT

K072920 · Roche Diagnostics Corp. · GJS · Jan 31, 2008 · Hematology

Device Facts

• Record ID: K072920
• Device Name: HANDHELD BASE UNIT
• Applicant: Roche Diagnostics Corp.
• Product Code: GJS · Hematology
• Decision Date: Jan 31, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Intended Use

The device is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.

Device Story

CoaguChek XS Plus Handheld Base Unit (HBU) serves as a docking station for the CoaguChek XS Plus PT instrument. HBU functions include recharging the internal battery and facilitating data connectivity between the instrument and external computers. HBU utilizes POCT1-A protocol to identify docked instruments and trigger automatic host communication via infrared or IrDA. HBU features a USB configuration switch for three operational modes: Ethernet (converts IrDA to wired Ethernet), Serial & Ethernet (converts USB Comm to serial infrared or IrDA to Ethernet), and Configuration (acts as a mass storage device). Used in clinical settings by healthcare professionals to manage data transfer from the PT instrument to hospital networks or computer systems.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Docking station form factor; infrared/IrDA connectivity; Ethernet and USB interfaces. Complies with IEC 62304 (Medical device software - Software life cycle processes).

Indications for Use

Indicated for professional healthcare providers monitoring warfarin therapy via quantitative prothrombin time testing using fresh capillary or non-anticoagulated venous whole blood.

Regulatory Classification

Identification

A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Predicate Devices

• CoaguChek XS Plus (K072920)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
k072920

B. Purpose for Submission:
Abbreviated submission for the clearance of a modification to the currently cleared CoaguChek XS Plus

C. Manufacturer and Instrument Name:
ROCHE DIAGNOSTICS CORP.
CoaguChek XS Plus Handheld Base Unit (HBU)

D. Type of Test or Tests Performed:
Prothrombin Time

E. System Descriptions:

1. Device Description:
The Handheld Base Unit is an accessory to the CoaguChek XS Plus PT instrument that provides the ability to recharge the internal battery of the CoaguChek XS Plus and facilitates the connectivity of the CoaguChek XS Plus to an external computer in order to download the device memory.

2. Principles of Operation:
The HBU uses a POCT1-A protocol to identify a docked instrument in order to trigger the automatic host communication. Connectivity between the HBU and CoaguChek XS Plus is established either via infrared or IrDA.

3. Modes of Operation:
A switch (USB configuration switch), on the back side of the Handheld Base Unit, sets the BASE to one of three different modes of operation:

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| Position | Mode | Description |
| --- | --- | --- |
| 1 | Ethernet | The BASE converts meter communication (IrDA) received on the BASE’s IR window to wired Ethernet. |
| 2 | Serial & Ethernet | The BASE converts host communication (USB Comm) to serial infrared on the BASE’s IR window.
-or-
The BASE converts meter communication (IrDA) received on the BASE’s IR window to wired Ethernet.
Note: The BASE cannot handle Serial & Ethernet conversion simultaneously. Both communication paths will be handled on after the other by means of timeouts. |
| 3 | Configuration | The BASE acts as a mass storage device on the USB port. Writing and reading files, using the mounted mass storage file system is the way to communicate with the BASE. |

4. Specimen Identification:
N/A

5. Specimen Sampling and Handling:
N/A

6. Calibration:
N/A

7. Quality Control:
N/A

8. Software:
FDA has reviewed applicants Hazard Analysis and Software Development

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processes for this line of product types:

Yes ☐ X ☑ or No ☐

## F. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| GJS | II | 21 CFR 864.7750 | 81 Hematology |

## G. Intended Use:

1. Indication(s) for Use:

The device is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.

2. Special Conditions for Use Statement(s):

Prescription

## H. Substantial Equivalence Information:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood. | Same |
| Measuring | 0.8- 8.0 INR | Same |

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| range | | |
| --- | --- | --- |
| Reagent | Human recombinant thromboplastin | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Router Component: | HBU incorporates the router component into the HBU. Roche now has direct design control of this component. | Connected to a hospital network via an off-the-shelf router component. |
| Physical Characteristics | Serves as a docking station for the predicate device. | Uses docking station for charging and data transfer. |

I. Special Control/Guidance Document Referenced (if applicable):

| STANDARDS |
| --- |
| Title and Reference Number |
| Medical device software - Software life cycle processes (62304 Ed. 1.0) |

Other Standards

| GUIDANCE | | | |
| --- | --- | --- | --- |
| Document Title | Office | Division | Web Page |
| Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff | ODE | | http://www.fda.gov/cdrh/ode/guidance/337.html |

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

N/A

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b. Precision/Reproducibility:
N/A

c. Linearity:
N/A

d. Carryover:
N/A

e. Interfering Substances:
N/A

2. Other Supportive Instrument Performance Data Not Covered Above:

K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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

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