T-TEK

K050817 · R2 Diagnostics, Inc. · GJA · Dec 12, 2005 · Hematology

Device Facts

• Record ID: K050817
• Device Name: T-TEK
• Applicant: R2 Diagnostics, Inc.
• Product Code: GJA · Hematology
• Decision Date: Dec 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7875
• Device Class: Class 2

Intended Use

The T-Tek thrombin time reagent is intended for use in the quantitative determination of Thrombin Time (TT) in citrated human plasma in the general population. T-Tek should be used in the clinical laboratory by qualified laboratory professionals. The test may be performed using manual, semi-automated, or automated coagulation analyzers.

Device Story

T-Tek is a lyophilized thrombin reagent used for quantitative determination of thrombin time in citrated human plasma. It is intended for use in clinical laboratories by qualified professionals. The reagent is added to plasma samples to initiate clotting; the test is performed manually or via semi-automated/automated coagulation analyzers. The device detects fibrinogen disorders. Healthcare providers use the resulting clotting time measurements to assess coagulation status and guide clinical decision-making regarding patient fibrinogen levels or heparin therapy. The device provides a diagnostic tool for identifying coagulation abnormalities.

Clinical Evidence

Bench testing only. Precision studies (within-run CV <7%, between-run CV <4%) performed on ACL 3000 and STA Compact analyzers. Method comparison study (n=125 and n=128) showed correlation with predicate (r=0.894 and r=0.895). Interference testing confirmed effects of hemolysis, lipemia, bilirubin, heparin, and direct thrombin inhibitors. Reference range established using 120 normal donor samples.

Technological Characteristics

Lyophilized thrombin reagent. Formulated for use in citrated plasma. Compatible with manual, semi-automated, and automated coagulation analyzers. No specific materials of construction or software algorithms described; functions as a chemical reagent for in vitro diagnostic testing.

Indications for Use

Indicated for the quantitative determination of thrombin time in citrated plasma for the general patient population to detect disorders of fibrinogen. For professional use in clinical laboratories only.

Regulatory Classification

Identification

A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.

Predicate Devices

• STA Thrombin (K884384)

Submission Summary (Full Text)

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Premarket Notification 510(k) T-Tek

## DEC 1 2 2005

K050817

8.0 Premarket Notification 510(k) Summary [As required by section 807.92(c)]

| Applicant: | Michael J. Morris<br>R2 Diagnostics, Inc.<br>412 South Lafayette Blvd.<br>South Bend, IN 46601<br>USA |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Peggy S. Carter<br>R2 Diagnostics, Inc.<br>412 South Lafayette Blvd.<br>South Bend, IN 46601<br>TEL: [phone]<br>FAX: [phone] |
| Date: | October 25, 2005 |
| Trade Name: | R2 Diagnostics T-Tek |
| Common Name: | Thrombin time test |
| Classification Name: | Test, thrombin time<br>(per 21 CFR section 864.7875) |
| Comparison Device: | STA Thrombin, K884384 |

### Description of the Device and Intended Use

The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated human plasma. The thrombin time test is a one-stage quantitative clotting test performed on citrated plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals. The test may be performed manually, or using semi-automated and automated coagulation analyzers.

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## Summary of Substantial Equivalence Comparisons

R2 Diagnostics T-Tek Thrombin Time Reagent is substantially equivalent in intended use and performance to STA Thrombin 10. Both the predicate device and the proposed product are formulated to determine thrombin time in citrated plasma. In correlation studies normal and abnormal patient plasma, as well as plasma samples from patients undergoing heparin therapy, were tested using both reagents. Comparison of data from thrombin time testing at two sites and on two different instrument types yielded correlation coefficients of r2 = 0.801 (photo-optical), slope = 0.848, intercept = 3.466 and 2 = 0.800 (mechanical), slope = 1.204, intercept = - 4.904. Within-run and between-run precision studies were also performed and CV's of less than 3% were obtained for the proposed device. CV's of less than 3% are reported for the predicate device in the manufacturers Instructions for Use.

# Conclusion: Substantial Equivalence Statement

In Summary, the similar intended use, technological characteristics and the performance data provided in this premarket notification demonstrate that R2 T-Tek Thrombin Time Reagent is substantially equivalent to (Diagnostica Stago) American Bioproducts Co., STA Thrombin 10.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 2 2005

Dr. Peggy S. Carter Director, Product Development R2 Diagnostics, Inc. 412 South Lafayette Blvd South Bend, IN 46601

k050817 Re: Trade/Device Name: T-Tek Regulation Number: 21 CFR 864.7875 Regulation Name: Thrombin time test Regulatory Class: Class II Product Code: GJA Dated: October 26, 2005 Received: November 1, 2004

Dear Dr. Carter:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, PH.D 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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### 6.0 Indications for Use

510(k) Number (if known): _KOSOKIT

Device Name: ____T-Tek

Indications for Use:

#### Statement of Indications for Use

The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated plasma. The thrombin time test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals.

Prescription Use X (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 Device Evaluation (ODE)

Page _1_of _1

(Posted November 13, 2003)

Josephine Bautista

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K050817