INRATIO 2 PT MONITORING SYSTEM

K072727 · Hemosense, Inc. · GJS · Oct 26, 2007 · Hematology

Device Facts

• Record ID: K072727
• Device Name: INRATIO 2 PT MONITORING SYSTEM
• Applicant: Hemosense, Inc.
• Product Code: GJS · Hematology
• Decision Date: Oct 26, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Indications for Use

The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring System is not intended to be used for screening purposes.

Device Story

System consists of monitor and disposable test strips; measures prothrombin time (PT) in capillary whole blood. Operates via modified one-stage PT test using recombinant human thromboplastin; detects clot formation through changes in electrical impedance. Used by patients on anticoagulant therapy for home monitoring. User applies capillary blood directly to test strip; monitor performs automated self-checks and provides quantitative PT results. Modifications from predicate include increased memory capacity (120 tests), updated software access interface, removed printing capability, and altered physical dimensions/display screen.

Clinical Evidence

Bench testing only. Sponsor provided risk analysis and Declaration of Conformity with Design Controls confirming product specifications were met following hardware and software modifications.

Technological Characteristics

Uses recombinant human thromboplastin reagent; sensing principle based on electrical impedance change during coagulation; monitor includes heating element for test strip temperature control; disposable test strips; hardware and software modifications from predicate.

Indications for Use

Indicated for quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood for patients on warfarin or other oral anticoagulant therapy requiring clotting time monitoring. Not for screening purposes.

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

• INRatio® System (K020679)

Submission Summary (Full Text)

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

A. 510(k) Number:
K072727

B. Purpose for Submission:
Special 510(k) for hardware and software modifications

C. Manufacturer and Instrument Name:
HemoSense, INC

D. Type of Test or Tests Performed:
Prothrombin Time Test

E. System Descriptions:

1. Device Description:
The INRatio 2 PT Monitoring System consists of a monitor, disposable test strips, user guide, quick reference guide, training video/DVD, and testing supplies.

2. Principles of Operation:
The INRatio 2 PT Monitoring System performs a modified version of the one-stage prothrombin time test using a recombinant human thromboplastin reagent. The clot formed in the prothrombin time reaction is detected by a change in the electrical impedance of the sample during the coagulation process.

3. Modes of Operation:
Manual mode.

4. Specimen Identification:
Manual input

5. Specimen Sampling and Handling:

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Capillary blood is added directly to the test strip

6. Calibration:
Factory calibration. The monitor performs self-checks at start-up and throughout the testing process.

7. Quality Control:
On board bi-level controls

8. Software:
FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:
Yes ☐ X or No ☐

F. Regulatory Information:

1. Regulation section:
21 CFR 864.7750

2. Classification:
Class II

3. Product code:
GJS

4. Panel:
81 Hematology

G. Intended Use:

1. Indication(s) for Use:
The INRatio 2 PT Monitoring System is used for the quantitative measurement of prothrombin time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio 2 PT Monitoring system is not intended to be used for screening purposes.

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2. Special Conditions for Use Statement(s):

H. Substantial Equivalence Information:

1. Predicate Device Name(s) and 510(k) numbers:

HemoSense INRatio (K020679)

2. Comparison with Predicate Device:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Quantitative measurement of prothrombin time in fresh capillary whole blood | same |
| Sample Volume | 15 ul | same |
| QC | Onboard bi-level controls | same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Memory | 120 tests | 60 tests |
| Software- Access | From various buttons | Only from Menu button |
| Software – Printing capability from memory | No capability | Able to |
| Display Screen | LCD, FSTN, 44mmH x 58 mmW | LCD, 128 x 64 matrix |
| Device size | 5.9’H x 2.9” W x 1.8” D | 6.2”H x 3” W x 2.25” D |

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

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

b. Precision/Reproducibility:

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c. Linearity:

d. Carryover:

e. Interfering Substances:

2. Other Supportive Instrument Performance Data Not Covered Above:

As required for a Special 510(k), the Sponsor has provided a risk analysis as well as a Declaration of Conformity with Design Controls indicating that development activities were conducted under appropriate design controls procedures, and the overall product specifications were met.

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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