(135 days)
K9911434
Not Found
No
The device description details a standard enzyme-linked immunoassay (EIA) process, which relies on antibody binding and colorimetric detection, not AI/ML algorithms for analysis or interpretation. The performance studies describe statistical correlations and clinical observations, not the training or testing of an AI/ML model.
No.
The device is an in vitro diagnostic (IVD) test designed to measure soluble fibrin polymers in plasma to assess thrombosis risk and monitor anticoagulant therapy, not to treat a condition.
Yes
The device aids in assessing the risk of intravascular thrombosis and monitoring the efficacy of anticoagulant therapy by measuring soluble fibrin polymers in plasma, which are diagnostic purposes.
No
The device description clearly outlines a laboratory-based enzyme-linked immunoassay (EIA) kit, which involves physical reagents, microtiter plates, and colorimetric measurement, indicating it is a hardware-based diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "quantitative determination of soluble fibrin polymers in human plasma" and is indicated as an "aid in assessing the risk of intravascular thrombosis and monitoring the efficacy of anticoagulant (heparin) therapy." This clearly indicates it is used to test a sample taken from the human body (plasma) to provide information about a medical condition (risk of thrombosis, efficacy of therapy).
- Device Description: The description details a laboratory-based assay (ELISA) performed on a biological sample (human plasma). This is a hallmark of IVD devices.
- Performance Studies: The performance studies involve testing human plasma samples from patients to evaluate the device's ability to measure the analyte and correlate with clinical outcomes.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The ABS, Inc. TpP™ EIA is an enzyme linked immunoassay for the quantitative determination of soluble fibrin polymers in human plasma. It is indicated as an aid in assessing the risk of intravascular thrombosis and monitoring the efficacy of anticoagulant (heparin) therapy.
Product codes (comma separated list FDA assigned to the subject device)
KQ1
Device Description
The TpP™ EIA employs a murine monoclonal antibody (MAb), specific for soluble fibrin polymer, as a capture antibody immobilized on a microtiter plate (MTP). This MAb recognizes a conformational epitope present only on the TpP™ entities but which is absent from fibrinogen and degradation products of fibrin and fibrinogen. During the first incubation phase TpP™ in human plasma specimens bind to the capture antibody. Afterwards the plate is rinsed, and a conjugate, another murine monoclonal antibody, labeled with horseradish peroxidase (HRP) is added to the well. This peroxidase conjugated MAb binds to a separate site on the TpP™ molecule during a second incubation period. Excess enzyme conjugated MAb is washed out and a subsequent application and incubation with tetramethylbenzidine (TMB) substrate follows. The reaction after TMB incubation is terminated with dilute sulfuric acid. The level of the TpP™ present in the specimen sample is determined colorimetrically from the enzymatic activity of detection MAb conjugate. The intensity of the color is proportional to the concentration of TpP™. Calibrator standard is provided with the kit.
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
age 17 and older
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical study was conducted at Johns Hopkins Medical School, Baltimore, MD. Ninety (90) patients were recruited from a population of adults of both sexes, age 17 and older who were undergoing procedures to repair aortic aneurysm. There was a positive correlation (0.58, p=0.008) for the increase in the two analytes following surgery. The mean value for all F1.2 patients started to decrease at 6 hours which is further confirmed by a lower correlation coefficient of 0.3 (p=0.19) as calculated for the increase in TpP™ and F1.2 after 6 hours. As F1.2 approached normal levels at t=12 hours post surgery TpP™ levels remained elevated and consequently the correlation between the ratios at 12 hours postsurgery decreased to 0.23 (p=0.31). From these results it can be concluded that elevations of TpP™ and F1.2 are correlated immediately following surgery and TpP™ levels persist at an elevated level for longer time periods. This physiological response suggests that ToP™ could serve as an alternative but equivalent marker to F1.2 for evaluating patients in a hypercoagulable state and as an aid to assess patients at risk of intravascular thrombosis.
The utility of the TpP™ EIA to distinguish patients with increased risk of thrombosis during a surgical procedure (PTCA) was evaluated at the Philadelphia Heart Institute. In the study, 25 PTCA patients were administered systemic heparin to achieve an activated clotting time of >300 seconds. Four (4) of the 25 patients proceeded to serious thrombotic complications The TpP™ values for these four patients never returned to normal values indicating active thrombosis. High TpP™ levels post heparinization suggest that the anticoagulant therapy was not adequate to maintain normal hemostatic function. From this data it may be concluded that the TpP™ EIA could serve as an aid in monitoring the efficacy of anticoagulant (heparin) therapy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linear Reportable Range : 0 to 40 µg/ml
Minimum Detectable Level: 0.177 µg/mL
Precision:
Sample A (mean=23.64 µg/mL): Within-Run Standard Deviation 0.36, Within-Run Coefficient of Variation (%) 1.50, Total Precision Standard Deviation 2.40, Total Precision Coefficient of Variation (%) 10.15
Sample B (mean=7.91 µg/mL): Within-Run Standard Deviation 0.29, Within-Run Coefficient of Variation (%) 3.70, Total Precision Standard Deviation 0.85, Total Precision Coefficient of Variation (%) 10.80
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.
K9911434
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.
Not Found
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).
Not Found
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).
0
OCT 1 8 1996
K962176
AMERICAN BIOGENETIC SCIENCES, INC.
1539 North Ironwood Drive, South Bend, IN 46635 · Tel: (219) 271-3415 Fax: (219) 271-3423 Premarket Notification Summary
TpP™ EIA
The ABS, Inc. TpP™ EIA is an enzyme linked immunoassay for the quantitative determination of soluble fibrin polymers in human plasma. It is indicated as an aid in assessing the risk of intravascular thrombosis and monitoring the efficacy of anticoagulant (heparin) therapy. The TpP™ EIA employs a murine monoclonal antibody (MAb), specific for soluble fibrin polymer, as a capture antibody immobilized on a microtiter plate (MTP). This MAb recognizes a conformational epitope present only on the TpP™ entities but which is absent from fibrinogen and degradation products of fibrin and fibrinogen. During the first incubation phase TpP™ in human plasma specimens bind to the capture antibody. Afterwards the plate is rinsed, and a conjugate, another murine monoclonal antibody, labeled with horseradish peroxidase (HRP) is added to the well. This peroxidase conjugated MAb binds to a separate site on the TpP™ molecule during a second incubation period. Excess enzyme conjugated MAb is washed out and a subsequent application and incubation with tetramethylbenzidine (TMB) substrate follows. The reaction after TMB incubation is terminated with dilute sulfuric acid. The level of the TpP™ present in the specimen sample is determined colorimetrically from the enzymatic activity of detection MAb conjugate. The intensity of the color is proportional to the concentration of TpP™. Calibrator standard is provided with the kit.
The data and information in this submission demonstrate that American Biogenetic Sciences' TpP™ EIA is substantially equivalent to Organon Teknika Corporation's immunochemical assay Thrombonostika F1.26, K9911434. KQ1 | | 434
These devices are similar in their intended use and methodology. Both utilize enzyme conjugated antibodies that bind to the analyte and react with the substrate TMB to directly measure species in blood which reflect activation of the coagulation system. These devices are dissimilar in that F1.2 tests measure a molecular entity which is generated in the penultimate stage of fibrin formation, i.e. during the conversion of prothrombin to thrombin. Although prothrombin is converted to thrombin, the latter is not necessarily coincident with fibrin (clot) formation. This is due to multiple inhibitors and substrates of thrombin. TpP™ consists of polymeric soluble fibrin entities which ultimately form fibrin in a clot. TpP™ is, therefore, coincident with fibrin formation as well as an indicator of thrombin activity.
These differences are not considered significant and have no effect on the safety and effectiveness of the product.
In order to determine the expected normal range for the TpP™ EIA, as well as to determine an effective cutoff point, several control populations were tested at several sites.
1
There were a total of 140 subjects used (115 healthy volunteers from Site #1, 8 healthy volunteers and 17 outpatients from site #2). The best estimate of an effective cutoff value was determined to be 6.65 µg/mL by employing a percentile evaluation.
A clinical study was conducted at Johns Hopkins Medical School, Baltimore, MD. Ninety (90) patients were recruited from a population of adults of both sexes, age 17 and older who were undergoing procedures to repair aortic aneurysm. There was a positive correlation (0.58, p=0.008) for the increase in the two analytes following surgery. The mean value for all F1.2 patients started to decrease at 6 hours which is further confirmed by a lower correlation coefficient of 0.3 (p=0.19) as calculated for the increase in TpP™ and F1.2 after 6 hours. As F1.2 approached normal levels at t=12 hours post surgery TpP™ levels remained elevated and consequently the correlation between the ratios at 12 hours postsurgery decreased to 0.23 (p=0.31). From these results it can be concluded that elevations of TpP™ and F1.2 are correlated immediately following surgery and TpP™ levels persist at an elevated level for longer time periods. This physiological response suggests that ToP™ could serve as an alternative but equivalent marker to F1.2 for evaluating patients in a hypercoagulable state and as an aid to assess patients at risk of intravascular thrombosis.
The utility of the TpP™ EIA to distinguish patients with increased risk of thrombosis during a surgical procedure (PTCA) was evaluated at the Philadelphia Heart Institute. In the study, 25 PTCA patients were administered systemic heparin to achieve an activated clotting time of >300 seconds. Four (4) of the 25 patients proceeded to serious thrombotic complications The TpP™ values for these four patients never returned to normal values indicating active thrombosis. High TpP™ levels post heparinization suggest that the anticoagulant therapy was not adequate to maintain normal hemostatic function. From this data it may be concluded that the TpP™ EIA could serve as an aid in monitoring the efficacy of anticoagulant (heparin) therapy.
The performance of the TpP™ EIA was confirmed by linearity, precision, and interference testing. Results are reported below.
| Linear Reportable Range : | 0 to 40 µg/ml |
|---|---|
| Minimum Detectable Level: | 0.177 µg/mL |
| Interference: | The TpP™ EIA has been evaluated with potential interfering substances. This interference study utilized a dose response method utilizing Hemoglobin (5, 2.5, 1, 0.5, 0.1 mg/mL), Bilirubin (0.2, 0.1, 0.05, 0.025, 0.01 mg/mL), Triglycerides (400, 250, 200, 125, 50 mg/dL), and Urokinase (1000, 500, 400, 200, 100 NIHU/ml). No significant interference was observed between normal plasma samples and normal plasma samples spiked with the noted level of analyte (interferent). |
2
Precision
Variability was determined by testing two samples over 10 days, one run per day, with replicates of 2 in each run. A single manufactured lot of kits, one kit utilized for each run, was employed. The concentrations were calculated from a calibration curve, with sample A, mean=23.64 µg/mL, selected well above the pathological cutoff and sample B, mean=7.91 µg/mL, selected near the pathological cutoff. Assay variances, standard deviation and coefficient of variation, were determined according to the NCCLS guideline EP5-T2.
| Sample | Mean TpPTM
value (µg/mL) | Within-Run
Standard
Deviation | Within-Run
Coefficient of
Variation (%) | Total Precision
Standard
Deviation | Total Precision
Coefficient of
Variation (%) |
|--------|-----------------------------|-------------------------------------|-----------------------------------------------|------------------------------------------|----------------------------------------------------|
| A | 23.64 | 0.36 | 1.50 | 2.40 | 10.15 |
| B | 7.91 | 0.29 | 3.70 | 0.85 | 10.80 |