(120 days)
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.
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.
Here's an analysis of the provided text regarding the FiF™ Test's acceptance criteria and the supporting study:
The document describes a premarket notification for the American Biogenetic Sciences, Inc.'s FiF™ Test, an immunoprecipitation test for the quantitative determination of fibrinogen in human plasma. The primary acceptance criterion for this submission is demonstrating substantial equivalence to a predicate device, the Baxter Dade®, Data-Fi®, Fibrinogen determination kit.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document explicitly states the overall acceptance criterion as demonstrating substantial equivalence to the predicate device. The performance metrics presented below are the data used to support this claim, rather than a predefined "pass/fail" threshold for each metric. The strong correlation (R^2 = 0.83, p=0.0001) is the central piece of evidence for substantial equivalence.
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance | Comments by ABS, Inc. |
|---|---|---|
| Quantitative Determination of Fibrinogen in Human Plasma | Strong positive correlation (R^2=0.83, p=0.0001) with predicate device. | Demonstrates substantial equivalence. |
| Linear Reportable Range | 50-1300 mg/dL | Confirms a wide range of accurate measurement. |
| Minimum Detectable Level | 59 mg/dL | Indicates sensitivity. |
| Interference with Common Substances | No significant interference reported/implied for: 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, Citrate. | Addresses potential sources of error inherent in blood plasma testing. The FiF™ test is specifically noted as not affected by anticoagulants or elevated fibrin/fibrinogen degradation products, which do affect the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 101 plasma samples.
- Data Provenance:
- Country of Origin: Not explicitly stated, but given the company's US address (South Bend, IN, and later Boston, MA), it is highly likely the samples were collected in the United States.
- Retrospective or Prospective: The samples were collected "from patients in the ER, Catherization Laboratory and also healthy volunteers" with "patient consent." This suggests a prospective collection for the purpose of this study, though some could be leftover samples. The phrasing "collected at the same time" for analysis further supports a planned, concurrent study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable.
- Qualifications: Not applicable.
This study does not involve human interpretation or expert evaluation to establish ground truth. Instead, the "ground truth" for comparison is the measurement produced by a predicate device (the Baxter Dade®, Data-Fi® test), which is an established, quantitative laboratory test.
4. Adjudication Method
- Adjudication Method: Not applicable.
As mentioned above, this study compares a new quantitative test to an existing quantitative predicate device, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No.
- Effect Size: Not applicable.
This Preamarket Notification is for a standalone in vitro diagnostic (IVD) device, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
- Standalone Study Done: Yes. The entire study describes the performance of the FiF™ Test (the "algorithm only," in a sense, as it's a fully automated or semi-automated lab test) independent of human interpretation beyond running the test and reading its numerical output. Its performance is compared directly to the predicate device.
7. Type of Ground Truth Used
- Ground Truth Type: A predicate device's measurement. The FiF™ Test's results were compared to the results obtained from the Baxter Dade®, Data-Fi® functional test on the same samples. This serves as the comparative "reference standard" to establish substantial equivalence.
8. Sample Size for the Training Set
- Sample Size: Not applicable.
This is a predicate comparison study for an IVD kit, not a machine learning model requiring a training set. The device is a chemical/immunological assay, not an AI or algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable.
As there is no training set for this type of device, this question is not relevant.
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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.
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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.
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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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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)
§ 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.