COAGUCHEK XS PLUS SYSTEM

K071041 · Roche Diagnostics · GJS · May 11, 2007 · Hematology

Device Facts

• Record ID: K071041
• Device Name: COAGUCHEK XS PLUS SYSTEM
• Applicant: Roche Diagnostics
• Product Code: GJS · Hematology
• Decision Date: May 11, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

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.

Device Story

Portable coagulation monitoring system for professional use in clinical settings. Inputs: 10 uL fresh capillary or non-anticoagulated venous whole blood applied to test strip. Principle: Amperometric detection of thrombin activity. System comprises Handheld Basic Module (HBM), Measurement Module (MM), and Barcode Reader (BR). HBM manages power, data, and IR communication; MM converts raw signals to PT results using identical software to predicate. BR enables automatic strip lot identification via 2D barcode. Output: Quantitative PT result (INR) displayed on screen. Features include QC lockout, memory for 500 results, and patient/operator ID entry. Healthcare providers use results to adjust warfarin therapy, potentially improving patient anticoagulation management.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements (21 CFR 820.30) to assess impact of hardware and software modifications.

Technological Characteristics

Handheld diagnostic device; includes barcode reader, base unit, and QC control chip. Software updated for enhanced UI and QC handling. Memory capacity increased. QC lock-out feature implemented.

Indications for Use

Indicated for professional healthcare providers to perform quantitative prothrombin time (PT) testing for monitoring warfarin therapy in patients 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).

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K071041

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.)
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 1) hardware changes including addition of a barcode reader., a handheld base unit, and a QC control chip for the optional external control 2) software changes associated with the hardware changes in #1, as well as an enhanced user interface and improved QC handling, 3) labeling changes

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, intended use, physical characteristics, and sample type and volume requirement. They differ in that the modified device now handles strip lot identification automatically using the barcode meter, and the memory capacity of the new device has been increased from 100 test results to 500 test results and from 0 code chip records to 60. Additionally, the modified device has a QC lock out feature that prevents an operator from performing testing if the QC fails. The old device did not include this feature.

5. 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.

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure.

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.