FIBROTEK FIB

K042919 · R2 Diagnostics, Inc. · GIS · Nov 29, 2004 · Hematology

Device Facts

• Record ID: K042919
• Device Name: FIBROTEK FIB
• Applicant: R2 Diagnostics, Inc.
• Product Code: GIS · Hematology
• Decision Date: Nov 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7340
• Device Class: Class 2

Intended Use

The FibroTek FIB Fibrinogen Kit is intended for use in the quantitative determination of fibrinogen in citrated human plasma. The Kit should only be used in an appropriate clinical laboratory by qualified laboratory professionals on diluted plasma samples in the general patient population; and for patients having possible fibrinogen disorders. The Kit may be used on automated or semi-automated, mechanical or photo-optical coagulation analyzers.

Device Story

FibroTek FIB is an in vitro diagnostic kit for quantitative fibrinogen measurement in citrated human plasma. Kit components include lyophilized human thrombin, calibrator plasma, and imidazole buffered saline. Principle of operation involves a one-stage quantitative assay performed on diluted plasma samples. Used in clinical laboratories by qualified professionals to detect fibrinogen disorders. Output is a quantitative fibrinogen level, aiding clinicians in diagnosing coagulation abnormalities. Device provides diagnostic information for patient management.

Clinical Evidence

Bench testing only. Precision evaluated using three levels of QC plasma; within-run CV 1.9–7.1%, between-run CV 1.72–7.34%. Method comparison performed against predicate using 110 normal and abnormal plasma samples on two analyzers (MLA 1000C and Stago STA Compact), showing R2 values of 0.9693 and 0.9582 respectively. Interference studies confirmed performance in the presence of hemoglobin, bilirubin, lipids, Argatroban, and hirudin. Reference ranges established using 120 normal samples.

Technological Characteristics

Reagents: lyophilized human thrombin, lyophilized calibrator plasma, imidazole buffered saline. Assay type: one-stage quantitative clotting assay. Form factor: diagnostic kit. Connectivity: none (manual/instrument-based). Sterilization: not applicable (in vitro diagnostic reagent).

Indications for Use

Indicated for quantitative fibrinogen determination in citrated human plasma for the general patient population and patients with possible fibrinogen disorders.

Regulatory Classification

Identification

A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

Special Controls

*Classification.* Class II (special controls). A control or fibrinogen standard intended for use with a fibrinogen determination system 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

• Pacific Hemostasis Fibrinogen Assay Set (K800826)

Submission Summary (Full Text)

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NOV 2 9 2004

Premarket Notification 510(k) FibroTek FIB

K042919

# 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 8, 2004 |
| Trade Name: | R2 Diagnostics FibroTek FIB |
| Common Name: | Fibrinogen test |
| Classification Name: | Test, Fibrinogen<br>(per 21 CFR section 864.7340) |
| Comparison Device: | Fibrinogen Assay Set, K800826 |

## Description of the Device and Intended Use

FibroTek FIB fibrinogen kit contains Human Thrombin 200, Fibrinogen Calibrator Plasma, and Imidazole Buffered Saline (IBS) and is intended for use in the quantitative determination of fibrinogen in citrated human plasma. The fibrinogen test is a quantitative assay used in the general patient population and for patients identified as having possible fibrinogen disorders. The fibrinogen test should be used in a clinical laboratory by qualified laboratory professionals.

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# Summary of Substantial Equivalence Comparisons

R2 Diagnostics FibroTek FIB is substantially equivalent in intended use and performance to Fibrinogen Assay Set. Both the predicate device and the proposed product are formulated to determine fibrinogen levels in 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 fibrinogen testing at two sites and on two different instrument types yielded correlation coefficients of t2 = 0.969 (photo-optical), slope = 0.859 and r2 = 0.958 (mechanical), slope = . 848. Withinrun and between-run precision studies were also performed and CV's of less than 8% were obtained for the proposed device. CV's of less than 6% are reported for the predicate device in the manufacturers Instructions for Use.

### Conclusion: Substantial Equivalence Statement

In Summary, the identical intended use, similar technological characteristics and the performance data provided in this premarket notification demonstrate that R2 FibroTek FIB is substantially equivalent to (Fisher Diagnostics) Pacific Hemostasis Fibrinogen Assay Set.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 9 2004

Peggy Carter, PhD Director, Product Development R2 Diagnostics 412 S. Lafavette Blvd. South Bend. IN 46601

k042919 Re:

Trade/Device Name: FibroTek FIB Regulation Number: 21 CFR 864.7320 Regulation Name: Fibrinogen/fibrin degradation product assay Regulatory Class: Class II Product Code: GIS, KQJ Dated: November 17, 2004 Received: November 19, 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/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker, Jr.

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices 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): __042917

Device Name: FibroTek FIB

Indications for Use:

### Statement of Indications for Use

The FibroTek FIB fibrinogen kit contains a lyophilized thrombin reagent, lyophilized calibrator plasma, and Imidazole Buffered Saline (IBS) for use in the quantitative determination of fibrinogen in citrated plasma. The fibrinogen test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The fibrinogen test is used to detect disorders of fibrinogen. The FibroTek FIB Fibrinogen Assay Kit 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)

Josephine Bruttke
**Division Sign-Off**

Division Sign-Off

Page 1_of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042919

(Posted November 13, 2003)