COAGUCHEK XS PT CONTROLS

K063823 · Roche Diagnostics Corp. · GGN · Jan 29, 2007 · Hematology

Device Facts

• Record ID: K063823
• Device Name: COAGUCHEK XS PT CONTROLS
• Applicant: Roche Diagnostics Corp.
• Product Code: GGN · Hematology
• Decision Date: Jan 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

CoaguChek XS PT Controls are intended for system checks and quality control of Prothrombin Time Testing with the CoaguChek XS monitor and CoaguChek XS PT test strips. for quality control testing using CoaguChek PT S Test ts with the CoaguChek S System by professional health care providers

Device Story

CoaguChek XS PT Controls consist of lyophilized non-human plasma containing varying levels of coagulation factors; provided with aqueous diluent in plastic bulb pipette. Used for quality control and system verification of CoaguChek XS monitor and PT test strips. Healthcare provider reconstitutes lyophilized plasma with diluent; mixes by swirling; applies to test strip. Device provides two levels of control (normal and abnormal) to ensure monitor accuracy. Used in clinical settings to validate system performance before patient testing. Stability: 30 minutes post-reconstitution.

Clinical Evidence

Bench testing only. Precision testing reported for two levels: Level 1 overall CV 1.1%; Level 2 overall CV 4.80%. No clinical data presented.

Technological Characteristics

Lyophilized non-human plasma with aqueous diluent, stabilizers, and preservative. Two levels: normal and abnormal. Reconstitution via plastic bulb pipette. Manual mixing. Stability: 30 minutes post-reconstitution.

Indications for Use

Indicated for quality control and system verification of Prothrombin Time (PT) testing performed on the CoaguChek XS monitor using CoaguChek XS PT test strips. Intended for use by professional healthcare providers.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• CoaguChek PT S System Controls (K0208631)

Submission Summary (Full Text)

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Kα63823

## 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | JAN 29 2007 |
| | Contact person: Theresa Ambrose Bush |
| | Date prepared: December 13, 2006 |
| Device Name | Proprietary name: CoaguChek XS PT Controls |
| | Common name: CoaguChek XS PT Controls |
| | Classification name: System, Multipurpose for in vitro coagulation studies |
| Establishment registration | The establishment registration number for Roche Diagnostics Mannheim is 961026. |
| Device Description | The control consists of lyophilized non-human plasma with varying levels of coagulation factors, which is reconstituted for use with diluent from a plastic bulb pipette. |
| Intended Use | CoaguChek XS PT Controls are intended for system checks and quality control of Prothrombin Time Testing with the CoaguChek XS monitor and CoaguChek XS PT test strips. |
| Substantial equivalence : Predicate Device | CoaguChek XS PT Controls is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed CoaguChek PT S System Controls cleared in the PT S Test Strips and Controls for the CoaguChek S System (K 0208631). |
| Comparison table | The below tables compare CoaguChek XS PT Controls with the predicate device, CoaguChek PT S System Controls (K0208631). |

| | Characteristic | CoaguChek XS PTControls | Predicate Device CoaguChek PT S System Controls (K0208631) |
|--|----------------|-------------------------|------------------------------------------------------------|
|--|----------------|-------------------------|------------------------------------------------------------|

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| Intended Use | CoaguChek XS PT Controls are intended for system checks and quality control of Prothrombin Time Testing with the CoaguChek XS monitor and CoaguChek XS PT test strips. for quality control testing using CoaguChek PT S Test ts with the CoaguChek S System by professional health care providers |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability | Unopened:<br>• Store at 2-8°C until expiration date<br>Reconstituted:<br>• Stable for 30 minutes |
| | Unopened:<br>• Store at 2-8°C. Do not freeze<br>• When stored at room temperature, controls are stable for 90 days or until expiration date, whichever comes first, when stored at room temperature (below 32°C).<br>Reconstituted<br>• Stable for 30 minutes |
| Matrix | Same Lyophilized non-human plasma (with varied levels of coagulation factors) with aqueous diluent, stabilizers, and preservative. |
| Levels | Same Two levels:<br>Level 1 normal<br>Level 2 abnormal |
| Handling | Same Lyophilized plasma that is reconstituted with diluent from a plastic bulb pipette, mixed by swirling, set aside while meter is activated, and used within 30 minutes of reconsititution. |
| Precision | Level 1: overall CV 1.1% Level 1: overall CV 4.80% |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure, with three stylized lines representing wings or feathers. Below the bird-like figure are three wavy lines, possibly representing water or movement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

ROCHE Diagnostics Corp. C/O Theresa Ambrose Bush 9115 Hague Road P.O. Box 50416 Indianapolis, Indiana 46250

Re: k063823

JAN 2 9 2007

Trade/Device Name: CoaguChek® XS PT Controls Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: Class II Product Code: GGN Dated: December 22, 2006 Received: December 26, 2006

Dear Ms. Bush:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally

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marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrf/industry/support/index.html.

Sincerely yours,

Robert H. Becker Jr.

Robert L. Becker, Jr., MD. Ph Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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cc: HFZ-401 DMC

HFZ-404 510(k) Staff HFZ- 440 Division D.O.

and the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of the

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## Indications for Use

510(k) Number (if known):

100000

Device Name: CoaguChek XS PT Controls

Indications For Use:

CoaguChek XS PT Controls are intended for system checks and quality control of Prothrombin Time Testing with the CoaguChek XS monitor and CoaguChek XS PT test strips.

Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Jorphine Bautista
Division Sig

Jivisi

Office of In Vitro Thagnostic Device Evaluation and Safe

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