(120 days)
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No
The device description details a standard immunoprecipitation assay with spectrophotometric measurement. There is no mention of AI/ML algorithms for data analysis, interpretation, or decision-making. The performance studies focus on correlation with a predicate device and standard analytical validation metrics.
No.
This device is an in-vitro diagnostic test used to determine fibrinogen levels, which aids in diagnosing conditions like disseminated intravascular coagulation, but it does not directly treat or alleviate a disease.
Yes
The device is a diagnostic device as its intended use is for the quantitative determination of fibrinogen in human plasma, which is used for testing conditions involving blood coagulation, such as disseminated intravascular coagulation and cardiovascular disease. This information is used for diagnosis or monitoring of a disease or condition.
No
The device description clearly outlines a laboratory test kit involving a monoclonal antibody, plasma samples, and absorbance measurements at 340nm. This indicates a physical, in-vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "testing of conditions in which blood coagulation is involved" and specifically mentions "quantitative determination of fibrinogen in human plasma." This indicates it's used to analyze a sample taken from the human body to provide information about a medical condition.
- Device Description: The description details a test that uses a "monoclonal antibody... specific for intact (undegraded) plasma fibrinogen" and measures the "change in sample absorbance" after adding the antibody to a "plasma sample." This describes a test performed in vitro (outside the body) on a biological sample.
- Sample Type: The test is performed on "human plasma," which is a biological specimen.
- Purpose: The purpose is to determine the concentration of fibrinogen, a substance in the blood, to aid in the diagnosis or monitoring of conditions related to blood coagulation.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ABS, Inc. FiF™ Test is an immunoprecipitation test indicated for the quantitative determination of fibrinogen in human plasma. A fibrinogen determination test is indicated for testing of conditions in which blood coagulation is involved. Such conditions include disseminated intravascular coaagulation, cardiovascular disease and primary fibrinolysis.
Product codes (comma separated list FDA assigned to the subject device)
KQJ, GIS
Device Description
The ABS, Inc. FiF™ Test is an immunoprecipitation test indicated for the quantitative determination of fibrinogen in human plasma. The FiR™ test employs a monoclonal antibody (Mab), specific for intact (undegraded) plasma fibrinogen. When added to a plasma sample the FiFTM MAb precipitates the fibrinogen from solution. The extent of the immunoprecipitate is determined by measuring the change in sample absorbance (at 340nm) after the addition of the FiFTM antibody. There is a linear correlation between the change in sample O.D. at 340nm and the concentration of fibrinogen in the solution. The test is calibrated using a standardized plasma sample provided with the kit.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human plasma
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A comparative study was performed on 101 plasma samples obtained (with patient consent). The patient samples were collected from patients in the ER, Catherization Laboratory and also healthy volunteers. The samples were analysed at the same time using both the ABS FiF™ test and Baxter Dade's Data-Fi® functional test. There was a strong positive correlation R2=0.83, (p=0.0001), demonstrating substantial equivalence of the two test systems. The performance of the FiF™ test was confirmed by linearity, precision and interference testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linear Reportable Range: 50-1300mg/dL
Minimum Detectable Level: 59mg/dL
Interference:
The FiF™ test has been evaluated with a number of interfering substances. These interference studies utilized a dose response method with: Hemoglobin (100mg/dL) Direct bilirubin (16mg/dL) Total bilirubin (14mg/dL) Triglycerides (250mg/dL) Fibrinogen degradation (50mg/dL) Fibrin degradation products (50mg/dL) Heparin, EDTA and citrate as anticoagulants for sample collection.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Baxter Dade®, Data-Fi®, Fibrinogen determination kit
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/0 description: The image shows a black and white logo. The logo is composed of geometric shapes, including rectangles, triangles, and a circle. The shapes are arranged to form an abstract design, with thick black lines defining the boundaries of each shape.
MAY
21 1997
AMERICAN BIOGENETIC SCIENCES, INC.
1539 North Ironwood Drive, South Bend, IN 46635 • Tel: (219) 271-3415 Fax: (219) 271-3423
Premarket Notification Summary
FiFTM Test
The ABS, Inc. FiF™ Test is an immunoprecipitation test indicated for the quantitative determination of fibrinogen in human plasma. The FiR™ test employs a monoclonal antibody (Mab), specific for intact (undegraded) plasma fibrinogen. When added to a plasma sample the FiFTM MAb precipitates the fibrinogen from solution.
The extent of the immunoprecipitate is determined by measuring the change in sample absorbance (at 340nm) after the addition of the FiFTM antibody. There is a linear correlation between the change in sample O.D. at 340nm and the concentration of fibrinogen in the solution. The test is calibrated using a standardized plasma sample provided with the kit.
The data and information in this submission demonstrate that American Biogenetic Sciences's FiF™ test is substantially equivalent to the Baxter Dade®, Data-Fi®, Fibrinogen determination kit. We believe that this product was available before May 28, 1976. The product insert for the predicate device has been included as Attachment B.
These two devices are similar in their intended use. Both make quantitative determination of fibrinogen in human plasma. Both employ standardized plasma controls for calibration. The Baxter Dade®, Data-Fi®, fibrinogen test is a functional test, measuring fibrinogen concentration as a function of the time it takes for a clot to form following the addition of excess thrombin to the test plasma sample.
The FiF™ test determines the level of fibrinogen by measuring the extent of immunoprecipitation when a fibrinogen specific antibody is added to the test plasma sample.
The Baxter functional assay maybe affected by the presence of anticoagulents such as heparin or by elevated levels of fibrinogen or fibrin degradation products. The ABS FiFTM test is not affected by anticoagulants or elevated fibrin/fibrinogen degradation products.
These differences are not considered significant and have no effect on the safety and effectiveness of the product.
A comparative study was performed on 101 plasma samples obtained (with patient consent.
1
The patient samples were collected from patients in the ER, Catherization Laboratory and also healthy volunteers. The samples were analysed at the same time using both the ABS FiF™ test and Baxter Dade's Data-Fi® functional test. There was a strong positive correlation R2=0.83, (p=0.0001), demonstrating substantial equivalence of the The performance of the FiF™ test was confirmed by linearity, two test systems. precision and interference testing. The results are summarized below:
| Linear Reportable Range: | 50-1300mg/dL |
|---|---|
| -------------------------- | -------------- |
59mg/dL Minimum Detectable Level:
Interference:
The FiF™ test has been evaluated with a number of interfering substances. These interference studies utilized a dose response method with: Hemoglobin (100mg/dL) Direct bilirubin (16mg/dL) Total bilirubin (14mg/dL) Triglycerides (250mg/dL) Fibrinogen degradation (50mg/dL) Fibrin degradation products (50mg/dL) Heparin, EDTA and citrate as anticoagulants for sample collection.
2
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three curved lines representing the body and wings.
Public Health Service
Public Health Servic
MAY 2 1 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ann D. McGonigle Regulatory and Quality Assurance American Biogenetic Sciences, Inc., ..... 801 Albany Street, Suite 300 Boston, Massachusetts 02118
Re : K970189 FiF™ Test II Regulatory Class: Product Code: KQJ, GIS March 31, 1997 Dated: Received: April 7, 1997
Dear Ms. McGonigle:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as - described in your 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.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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WED 16:04 FAX 6176386670
14/97
Page of
501 (k) Number (if known): K 970189
Device Name: FiF™ Test
Indications For Use:
A fibrinogen determination test is indicated for testing of conditions in which blood coagulation is involved. Such conditions include disseminated intravascular coaagulation, cardiovascular disease and primary fibrinolysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K970189 |
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_ (Optional Format 1-2-96)