(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.
§ 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.