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.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the FibroTek FIB device, including the requested information:

Acceptance Criteria and Device Performance for FibroTek FIB

This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo clinical performance criteria. Therefore, the "acceptance criteria" are implied by the performance of the predicate device and the requirement for the new device to demonstrate comparable performance. The study described is a comparison study against the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (FibroTek FIB)
Correlation with predicate device (Fibrinogen Assay Set) on various plasma types.	Correlation Coefficients: - Photo-optical instrument: r² = 0.969, slope = 0.859 - Mechanical instrument: r² = 0.958, slope = 0.848 (Tested on normal and abnormal patient plasma, and plasma samples from patients undergoing heparin therapy)
Within-run precision (CV) comparable to predicate (reported < 6%).	Within-run Precision: CV's of less than 8% were obtained.
Between-run precision (CV) comparable to predicate (reported < 6%).	Between-run Precision: CV's of less than 8% were obtained.
Identical intended use.	Identical Intended Use: Both the predicate and proposed product are formulated to determine fibrinogen levels in plasma. (Quantitative determination of fibrinogen in citrated human plasma, for general patient population and patients with possible fibrinogen disorders).
Similar technological characteristics.	Similar Technological Characteristics: The summary states "similar technological characteristics," implying the underlying method of fibrinogen determination is comparable to the predicate. (Further details are not provided in this summary, but typically refer to the reagent composition and reaction principles).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the exact number of samples used. It mentions "normal and abnormal patient plasma, as well as plasma samples from patients undergoing heparin therapy" were tested.
Data Provenance: The document does not specify the country of origin of the data. The study involved testing at "two sites and on two different instrument types," which suggests a multi-site evaluation. The data is presented as a prospective comparison study against the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of device (fibrinogen test kit) does not typically rely on "expert ground truth" in the same way an imaging or diagnostic AI model would. The "ground truth" for the test set is established by the measurement obtained from the predicate device. The performance of the FibroTek FIB is then compared to these measurements.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" for comparison is the measurement from the predicate device itself, not a consensus interpretation by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiologists, pathologists) and would assess the impact of AI assistance on their performance. The FibroTek FIB is an in-vitro diagnostic (IVD) test kit, where the result is generated by the instrument/reagent, not human interpretation of complex data.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance evaluation of the FibroTek FIB represents a standalone (algorithm/device-only) performance. The results (fibrinogen levels) are generated directly by the kit and associated laboratory instruments, without human interpretive input as part of the core measurement. The "human-in-the-loop" here refers to qualified laboratory professionals performing the test and interpreting the numerical output, not subjectively assessing raw data to reach a diagnosis.

7. The Type of Ground Truth Used

The ground truth used for this study was the measurements obtained from the predicate device (Fibrinogen Assay Set). The new device's performance was evaluated by its correlation and precision relative to an already legally marketed and established method.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable in the context of this traditional IVD kit submission. The FibroTek FIB is a chemical reagent kit, not an AI/ML algorithm that undergoes a training phase.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for a chemical reagent kit. The development of such kits involves chemical formulation, optimization, and rigorous manufacturing controls, rather than data-driven machine learning training.

Summary

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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. MorrisR2 Diagnostics, Inc.412 South Lafayette Blvd.South Bend, IN 46601USA
Contact:	Dr. Peggy S. CarterR2 Diagnostics, Inc.412 South Lafayette Blvd.South Bend, IN 46601TEL: (574) 288-4377FAX: (574) 288-2272
Date:	October 8, 2004
Trade Name:	R2 Diagnostics FibroTek FIB
Common Name:	Fibrinogen test
Classification Name:	Test, Fibrinogen(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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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

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

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042919

(Posted November 13, 2003)

Regulation Number and Section

§ 864.7340 Fibrinogen determination system.

(a)
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).(b)
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.