← Product Code [GJS](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS) · K212779

# Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (K212779)

_Coagusense, Inc. · GJS · Oct 5, 2022 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS/K212779

## Device Facts

- **Applicant:** Coagusense, Inc.
- **Product Code:** [GJS](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS.md)
- **Decision Date:** Oct 5, 2022
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 864.7750
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in INR units. It uses fresh capillary whole blood. The Coag-Sense Prothrombin Time (PT) / INR Monitoring System for Patient Self-Testing is intended for use by properly selected and suitably trained patients or their caregivers on the order of the treating physician to monitor patients who are on anticoagulation therapy. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self-testing. The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is not intended to be used for screening purposes. The Coag-Sense Prothrombin Time (PT)/INR Monitoring System for Patient Self-Testing is intended to be used by a single person and should not be shared.

## Device Story

System measures PT/INR from fresh capillary whole blood; utilizes test and control strips with established chemistry/reagents. Modification replaces color touchscreen with monochrome LCD and soft buttons; transitions power to 4 AA batteries; removes patient ID functionality. Intended for patient self-testing at home. Device provides quantitative INR results to assist patients in monitoring anticoagulant therapy. Fundamental scientific technology remains unchanged from predicate.

## Clinical Evidence

No clinical trials performed. Evidence consists of functional bench testing, electrical safety/EMC testing, and usability study. Usability study (IEC 62366-1) confirmed 100% of professional and self-test users found the modified interface easy to use. Side-by-side performance testing using identical test samples confirmed no difference in results between subject and predicate devices.

## Technological Characteristics

In vitro diagnostic system for PT/INR monitoring. Consists of meter with monochrome LCD, soft buttons, and test/control strips. Power source: 4 AA batteries. Sensing principle: mechanical/chemical detection via test strips (unchanged from predicate).

## Regulatory 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

- Coag-Sense Prothrombin Time (PT)/INR System For Patient Self-Testing ([K183255](/device/K183255.md))

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K212779

B Applicant

CoaguSense, Inc.

C Proprietary and Established Names

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  GJS | Class II | 21 CFR 864.7750 - Prothrombin Time Test | HE - Hematology  |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device (K183255).
2. Submitter's statement that the INDICATIONS FOR USE/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.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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Device modifications were made with respect to indications for patient self-testing use only. Modifications include a monochrome LCD screen with soft buttons, replacing the color touchscreen meter, use of 4 AA batteries for power and removal of patient ID. No changes have been made to the test and control strips, or the chemistry/reagents provided in the strips.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

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.

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 device.

K212779 - Page 2 of 2

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS/K212779](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/GJS/K212779)

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