(38 days)
Not Found
No
The description focuses on a chemical assay kit for fibrinogen determination and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic (IVD) test used to measure fibrinogen levels, which aids in detecting disorders related to fibrinogen. It is not used to treat or prevent a disease or condition.
Yes
The device is used for the "quantitative determination of fibrinogen in citrated plasma" and "to detect disorders of fibrinogen," which indicates its role in diagnosing medical conditions by assessing an analyte level.
No
The device description clearly states it is a "kit" containing lyophilized reagents and buffered saline, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of fibrinogen in citrated plasma." This is a test performed on a sample taken from the human body (plasma) to provide information about a physiological state (fibrinogen levels).
- Device Description: The description confirms it's a "kit" containing reagents for this determination.
- Clinical Laboratory Use: The intended user and setting are a "clinical laboratory by qualified laboratory professionals," which is a typical environment for IVD testing.
- Detection of Disorders: The intended use also mentions it's used to "detect disorders of fibrinogen," further indicating its diagnostic purpose.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality.
N/A
Intended Use / 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.
Product codes
GIS, KQJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The fibrinogen test should be used in a clinical laboratory by qualified laboratory professionals.
The FibroTek FIB Fibrinogen Assay Kit should only be used in an appropriate clinical laboratory by qualified laboratory professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
CV's of less than 8% were obtained for the proposed device. CV's of less than 6% are reported for the predicate device.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
NOV 2 9 2004
Premarket Notification 510(k) FibroTek FIB
8.0 Premarket Notification 510(k) Summary
[As required by section 807.92(c)]
| Applicant: | Michael J. Morris
R2 Diagnostics, Inc.
412 South Lafayette Blvd.
South Bend, IN 46601
USA |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Peggy S. Carter
R2 Diagnostics, Inc.
412 South Lafayette Blvd.
South Bend, IN 46601
TEL: (574) 288-4377
FAX: (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.
1
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.
2
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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Page 2
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
4
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)