(99 days)
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No
The device description and performance studies focus on a standard ELISA assay for measuring a specific protein fragment. There is no mention of AI, ML, image processing, or any computational analysis beyond standard statistical calculations for assay performance.
No
The device is an in vitro diagnostic assay used for quantitative determination of a fragment in human plasma to assess the risk of thrombosis and monitor anticoagulant therapy, not directly treat.
Yes
The device is an enzyme-linked immunosorbent assay (ELISA) designed for the quantitative determination of prothrombin activation fragment 1.2 (F1.2) in human plasma, which is explicitly indicated as an aid to assess the risk of thrombosis and monitor the efficacy of anticoagulant therapy. These applications are for diagnostic purposes.
No
The device is an in-vitro diagnostic (IVD) assay that involves chemical reactions and physical components (microelisa wells, antibodies, reagents). It is not solely software.
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 prothrombin activation fragment 1.2 (F1.2) in human plasma." This involves testing a sample taken from the human body (plasma) in vitro (outside the body).
- Indications for Use: The indications for use further clarify its purpose as an "aid to both assess the risk of thrombosis and monitor the efficacy of anticoagulant therapy." This is a diagnostic purpose, providing information to aid in medical decisions.
- Device Description: The description details an "enzymed-linked immunosorbent assay," which is a common laboratory technique used for in vitro testing of biological samples. It describes the process of analyzing a plasma sample to detect and quantify a specific analyte (F1.2).
- Sample Type: The device is designed to test "human plasma," which is a biological sample taken from a human.
All of these points align 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
Thrombonostika F1.2 is an enzymed-linked immunosorbent assay for the quantitative determination of prothrombin activation fragment 1.2 (F1.2) in human plasma. It is indicated as an aid to both assess the risk of thrombosis and monitor the efficacy of anticoagulant therapy.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Thrombonostika F1.2 is a two-stage enzymed-linked immunosorbent assay for the prothrombin activation peptide F.12. The high specificity of the solid-phase anti-F1.2 monoclonal antibody allows quantitation of nanomolar F1.2 in the presence of micromolar prothrombin that is typically found in plasma. Rabbit polyclonal antibodies to the calcium-dependent conformer of prothrombin (i.e., the amino terminal region present on both prothrombin and F1.2 ) coupled to horseradish peroxidase (HRP) serves as the conjugate with tetramethylbenzidine (TMB) used as the substrate.
In the first stage, test sample or calibrator is incubated with a monoclonal F1.2-specific antibody (murine) coated on a microelisa well. F1.2 binds to the solid-phase antibody. Following an incubation, unbound proteins (including prothrombin) are aspirated and the well washed with buffer. In the second stage, conjugate (rabbit) labeled with HRP is added. The enzyme-labeled antibody is bound to the solid-phase F1.2 complex. Following a wash and incubation with TMB substrate, blue color is produced that turns yellow hen the reaction is stopped with stop solution. Within limits, the amount of prothrombin fragment 1.2 is proportional to the color development.
Prothrombin fragment1.2 (F1.2) is a polypeptide released from prothrombin during its activation to thrombin. When formed, thrombin can convert fibrin which in turn can incorporate into thrombus. Because thrombin has many natural inhibitors and substrates, thrombin formation need not be coincident with fibrin formation. However, as more prothrombin activation occurs, the amount of thrombin available to form fibrin and potentially thrombi also increases. Conversely, when less prothrombin activation occurs (as may happen during anticoagulation), less thrombin is available to form fibrin and possible thrombi.
F1.2 levels reflect the extent of prothrombin activation in plasma and have been demonstrated to correlate with the thrombotic risk associated with certain patient populations. Mean F1.2 levels are elevated in those that are elderly, have inherited thrombophilia, or have deep vein thrombosis (DVT); these are all conditions with an increased risk of thrombosis. Mean F1.2 levels are depressed in those receiving oral anticoagulant therapy, or heparin infusion; these are conditions with decreased thrombotic risk. Monitoring of F1.2 levels will provide additional information for assessing thrombotic risk and monitoring efficacy of anticoagulant therapy.
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
Not Found
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)
Comparison Data:
The coefficient of determination ( R2 ) from regressing F1.2 values obtained without the 0.25 nM calibrator on the corresponding values obtained originally with the 0.25 nM calibrator is 0.998, with an estimated slope and intercept of 1.001and 0.001, respectively. These data and the estimated regression line are shown in Figure 1.0. Two hundred forty (240) of the 268 test results fall in the 0.0-1.0 nM range.
An additional 51 samples fresh patient samples were analyzed by the current version of the test and compared to results from modified version. The coefficient of determination obtained from regressing F1.2 values without the 0.25 nM calibrator on values obtained with the calibrator is 0.9999. The slope and the intercept of the regression line 0.987 and 0.036, respectively. These data and the estimated regression line are shown in Figure 2.0.
Sensitivity:
The minimum F1.2 level distinguishable from Calibrator A is 0.1 nM. This minimum detection limit is the F1.2 value corresponding to the mean absorbance plus two standard deviations for at least 16 replicates of Calibrator A.
Accuracy:
A mean recovery of 113.5% (SD=13%) was obtained when purified F1.2, at levels between 0.5-20 nM, was added to 16 plasma samples from 5 different donors
Precision:
Estimates of total and intra-assay precision were calculated for each of three kit lots by assaying multiple replicates of the Level I and Level II Controls on multiple plates and occasions. Intra-assay precision was estimated using analysis of variance. Total precision includes both interassay and intra-assay precision. Shown for each control and kit lot are the total number of tests (N), the mean F1.2 level (MEAN) in nM units, the total standard deviation (SD TOTAL) of all tests, the overall coefficient of variation (CV TOTAL), the intra-assay standard deviation (SD INTRA), and the intra-assay coefficient of variation (CV INTRA)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.1 nM
Accuracy: Mean recovery of 113.5% (SD=13%)
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.
Thrombonostika F1.2 (K911434)
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
:
:
MAR 1188 1997 11 1997
:
and the contraction of the comments of the comments of the comments of
510(k) Summary 9.0
and the comments of the comments of the comments of
1
510(k) SUMMARY
THROMBONOSTIKA F1.2
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and the final rule under 21 CFR 807.92 published December 14, 1994.
(a) (1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared;
Organon Teknika Corporation Submitter's Name: 100 Akzo Avenue, Durham, North Carolina 27712, USA Submitter's Address: (919) 620-2373 Submitter's Telephone: Ron Sanyal, M. Pharm, CQE, RAC Submitter's Contact: Date 510(k) Summmary Prepared: December 6, 1996
- The name of the device, including the trade or proprietary name if applicable, the common or (a) (2) usual name, and the classification name, if known;
| Trade/Proprietary Name: | Thrombonostika F1.2 |
|---|---|
| Common/ Usual Name: | ELISA for Prothrombin Fragment 1.2 |
| Classification Name: | Prothrombin Activation Fragment 1.2 (F1.2) |
An identification of the legally marketed device to which the submitter claims substantial (a) (3) equivalence.
Device Equivalent to: Thrombonostika F1.2 (K911434)
(a) (4) A description of the device(System)
Thrombonostika F1.2 is a two-stage enzymed-linked immunosorbent assay for the prothrombin activation peptide F.12. The high specificity of the solid-phase anti-F1.2 monoclonal antibody allows quantitation of nanomolar F1.2 in the presence of micromolar prothrombin that is typically found in plasma. Rabbit polyclonal antibodies to the calcium-dependent conformer of prothrombin (i.e., the amino terminal region present on both prothrombin and F1.2 ) coupled to horseradish peroxidase (HRP) serves as the conjugate with tetramethylbenzidine (TMB) used as the substrate.
In the first stage, test sample or calibrator is incubated with a monoclonal F1.2-specific antibody (murine) coated on a microelisa well. F1.2 binds to the solid-phase antibody. Following an incubation, unbound proteins (including prothrombin) are aspirated and the well washed with buffer. In the second stage, conjugate (rabbit) labeled with HRP is added. The enzyme-labeled antibody is bound to the solid-phase F1.2 complex. Following a wash and incubation with TMB substrate, blue color is produced that turns yellow hen the reaction is stopped with stop solution. Within limits, the amount of prothrombin fragment 1.2 is proportional to the color development.
Prothrombin fragment1.2 (F1.2) is a polypeptide released from prothrombin during its activation to thrombin. When formed, thrombin can convert fibrin which in turn can incorporate into thrombus. Because thrombin has many natural inhibitors and substrates, thrombin formation need not be coincident with fibrin formation. However, as more prothrombin activation occurs, the amount of thrombin available to form fibrin and potentially thrombi also increases. Conversely, when less prothrombin activation occurs (as may happen during anticoagulation), less thrombin is available to form fibrin and possible thrombi.
F1.2 levels reflect the extent of prothrombin activation in plasma and have been demonstrated to correlate with the thrombotic risk associated with certain patient populations. Mean F1.2 levels are elevated in those that are elderly, have inherited thrombophilia, or have deep vein thrombosis (DVT); these are all conditions with an increased risk of thrombosis. Mean F1.2 levels are depressed in those receiving oral anticoagulant therapy, or
2
heparin infusion; these are conditions with decreased thrombotic risk. Monitoring of F1.2 levels will provide additional information for assessing thrombotic risk and monitoring efficacy of anticoagulant therapy.
(a) (5) A statement of the intended use of the device.
Thrombonostika F1.2 is an enzymed-linked immunosorbent assay for the Device Intended Use: quantitative determination of prothrombin activation fragment 1.2 (F1.2) in human plasma. It is indicated as an aid to both assess the risk of thrombosis and monitor the efficacy of anticoagulant therapy.
3
A summary of the technological characteristics of the new device in comparision to those of the (a) (6) predicate device.
The technological characteristics of the new device in comparison to those of the device [Thrombonostika F1.2 (K911434)] are given in the table 1 below.
TABLE 1
| PARAMETERS | ORGNON TEKNIKA
THROMBONOSTIKA F1.2
(ORIGINAL) | ORGANON TEKNIKA
THROMBONOSTIKA F1.2
(MODIFIED) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CATEGORY | Enzyme-linked Immunosorbent
Assay (ELISA) | Enzyme-linked Immunosorbent
Assay (ELISA) |
| INTENDED USE | Thrombonostika F1.2 is an
enzymed-linked immunosorbent
assay for the quantitative
determination of prothrombin
activation fragment 1.2 (F1.2) in
human plasma. It is indicated as
an aid to both assess the risk of
thrombosis and monitor the
efficacy of anticoagulant therapy. | Thrombonostika F1.2 is an
enzymed-linked immunosorbent
assay for the quantitative
determination of prothrombin
activation fragment 1.2 (F1.2) in
human plasma. It is indicated as
an aid to both assess the risk of
thrombosis and monitor the
efficacy of anticoagulant therapy. |
| SAMPLE | Human Plasma | Human Plasma |
| SENSITIVITY | 0.1 nM | 0.1 nM |
| CONTROLS | Level I Control-Lyophilized
human plasma containing a low
F1.2 level
Level II Control-Lyophilized
human plasma containing a high
F1.2 level | Level I Control-Lyophilized
human plasma containing a low
F1.2 level
Level II Control-Lyophilized
human plasma containing a high
F1.2 level |
| MONOCLONAL ANTIBODY | Murine | Murine |
| CONJUGATE | Rabbit polyclonal antibodies to
the calcium-dependent conformer
of prothrombin (i.e., the amino
terminal region present on both
prothrombin and F1.2 ) coupled
to horseradish peroxidase (HRP)
serves as the conjugate | Rabbit polyclonal antibodies to
the calcium-dependent conformer
of prothrombin (i.e., the amino
terminal region present on both
prothrombin and F1.2 ) coupled
to horseradish peroxidase (HRP)
serves as the conjugate |
| CALIBRATORS | 0, 0.25, 1.0, 3.0, 6.0, 10 nM
Labeled with target values | 0, 1.0, 3.0, 6.0, 10.0 nM
Labeled with assayed values |
| SUBSTRATE | TMB (Tetramethylbenzidine) | TMB (Tetramethylbenzidine) |
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(b) (1) A brief discussion of the nonclinical tests submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalency.
Not Applicable
A brief discussion of the clinical tests submitted, reference, or relied on in the premarket (b)(2) notification submission for a determination of substantial equivalency.
Comparison Data:
The coefficient of determination ( R2 ) from regressing F1.2 values obtained without the 0.25 nM calibrator on the corresponding values obtained originally with the 0.25 nM calibrator is 0.998, with an estimated slope and intercept of 1.001and 0.001, respectively. These data and the estimated regression line are shown in Figure 1.0. Two hundred forty (240) of the 268 test results fall in the 0.0-1.0 nM range.
An additional 51 samples fresh patient samples were analyzed by the current version of the test and compared to results from modified version. The coefficient of determination obtained from regressing F1.2 values without the 0.25 nM calibrator on values obtained with the calibrator is 0.9999. The slope and the intercept of the regression line 0.987 and 0.036, respectively. These data and the estimated regression line are shown in Figure 2.0.
Sensitivity
The minimum F1.2 level distinguishable from Calibrator A is 0.1 nM. This minimum detection limit is the F1.2 value corresponding to the mean absorbance plus two standard deviations for at least 16 replicates of Calibrator A.
Accuracy
A mean recovery of 113.5% (SD=13%) was obtained when purified F1.2, at levels between 0.5-20 nM, was added to 16 plasma samples from 5 different donors
Precision
Estimates of total and intra-assay precision were calculated for each of three kit lots by assaying multiple replicates of the Level I and Level II Controls on multiple plates and occasions. Intra-assay precision was estimated using analysis of variance. Total precision includes both interassay and intra-assay precision. Shown for each control and kit lot are the total number of tests (N), the mean F1.2 level (MEAN) in nM units, the total standard deviation (SD TOTAL) of all tests, the overall coefficient of variation (CV TOTAL), the intra-assay standard deviation (SD INTRA), and the intra-assay coefficient of variation (CV INTRA)
The conclusion drawn from the nonclinical and clinical tests that demonstrate that the device is (b) (3) as safe, as effective, and performed as well or better than the legally marketed device identified in (a) (3).
In concusion, the Thrombonostika F 1.2 (Modified) has sucessfully met all aspects of non clinical and clinical testing and have demonstrated that the device is safe and effective and has performed well and is substantially equivalent to the legally marketed device [Thrombonostika F1.2 (K911434)].