(134 days)
Activated THROMBOFAX® Reagent-Optimized
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No
The summary describes a chemical reagent used in laboratory tests and does not mention any computational or algorithmic components indicative of AI/ML.
No
This device is a reagent used for diagnostic testing (APTT test), not for treating a disease or condition.
Yes
The device is a laboratory reagent used for the activated partial thromboplastin time (APTT) test, specific factor assays, APTT substitution test, and monitoring heparin therapy. These tests are performed to diagnose problems in the intrinsic pathway of coagulation or to monitor anticoagulant therapy.
No
The device description clearly states it is a "liquid buffered reagent," which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "two-stage activated partial thromboplastin time (APTT) test, specific factor assays, APTT substitution test and monitoring heparin therapy." These are all laboratory tests performed on biological samples (plasma) to provide information about a patient's health status.
- Device Description: The description details a "liquid buffered reagent" that is incubated with an "anticoagulated plasma sample" to initiate a coagulation process and measure the time to clot formation. This is a classic description of an in vitro diagnostic reagent used to analyze a biological sample outside of the body.
- Mechanism of Action: The explanation of how the reagent works (activating the intrinsic pathway of coagulation, binding of factors to phospholipid, clot formation) clearly describes a process happening in vitro (in a test tube or similar container).
- Performance Studies: The performance studies describe testing the reagent with "plasma samples" and "controls," which are typical for evaluating the performance of an IVD.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. SynthAFax APTT Reagent fits this definition perfectly.
N/A
Intended Use / Indications for Use
SynthAFax APTT Reagent is intended for the two-stage activated partial thromboplastin time (APTT) test, specific factor assays, APTT substitution test and monitoring heparin therapy.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
SynthAFax APTT Reagent is a liquid buffered reagent which contains a blend of synthetic phospholipids formed in liposomes, and a soluble plasma activator, ellagic acid, for optimal activation of the contact phase of coagulation. The use of synthetic phospholipids assures uniformity in the reagent and lot-to-lot consistency.
The activated partial thromboplastin time (APTT) test uses an activating agent and a phospholipid source and calcium to optimally activate the intrinsic pathway of coagulation. SynthAFax is incubated with an anticoagulated plasma sample for a standard period of time, known as the contact activation time (CAT). SynthAFax initiates the contact phase of coagulation through the activation of Factor XII. The addition of calcium chloride allows for the binding of other coagulation factors to the phospholipid and subsequent activation of the coagulation cascade. The generation of thrombin eventually cleaves fibrinogen and activates Factor XIII which crosslinks the fibrin molecules to form a visible clot. This occurs within a specified period of time.
If there is a coagulation factor deficiency in the intrinsic pathway, the time required for the formation of the clot will be prolonged beyond that expected for normal plasma. There will also be a prolongation of clotting caused by the presence of an inhibitor or the anticoagulant effect of heparin.
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
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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)
Precision Study: The performance of SynthAFax APTT Reagent was evaluated at Ortho Diagnostic Systems, Inc., Raritan, NJ. Precision studies were performed using both SynthAFax and Activated THROMBOFAX APTT Reagents and tested with ORTHO Plasma Coagulation Control (OPCC) Level I (normal control), II and III (abnormal controls). The precision was tested on four different instruments (Koagulab 60S, ELECTRA 1600, ELECTRA 1400, ELECTRA 1000). Grand Mean (sec.) for OPCC Level I (n=180) ranged from 22.4 to 25.0 for SynthAFax, and 22.7 to 24.5 for Activated Throm.; Replicate %CV (n=90) ranged from 0.7 to 0.9 for SynthAFax, and 0.4 to 0.5 for Activated Throm.; Run to Run %CV (n=30) ranged from 0.6 to 1.1 for SynthAFax, and 0.6 to 1.2 for Activated Throm.; Between Day %CV (n=5) ranged from 0.3 to 0.8 for SynthAFax, and 0.5 to 0.7 for Activated Throm. The results showed comparable precision between SynthAFax and Activated THROMBOFAX.
Reagent Correlation Study: A total of one hundred (100) fresh normal donor plasma samples and seventy nine (79) frozen abnormal plasma samples from forty one (41) patients on heparin therapy, eleven (11) patients on oral anticoagulant therapy, three (3) patients with liver disease, and twenty four (24) lupus anticoagulant patients were tested for APTT with both SynthAFax and Activated THROMBOFAX APTT Reagents, using the KoaguLab 60-S Coagulation System and the ELECTRA 1600C. For the KoaguLab 60-S, the correlation coefficient was 0.951, indicating acceptable correlation between the two reagents. The slope of the regression line was 1.08 indicating slightly more sensitivity for SynthAFax as compared to Activated THROMBOFAX APTT reagent. Similar results were seen on the ELECTRA 1600C with a correlation coefficient of 0.945 and a slope of 1.15.
Factor Assay Standard Curves: Factor VIII, IX, XI and XII Assay Standard Curves were performed with SynthAFax and Activated THROMBOFAX APTT Reagents on both the KoaguLab 60-S Coagulation System and ELECTRA 1600C. On the KoaguLab 60-S, the factor curve responsiveness was equivalent for Factors VIII, IX, XI, and XII compared to Activated THROMBOFAX, and all standard curves had correlation coefficients of 0.986 or better, indicating acceptable correlation. Factor curves on the ELECTRA 1600C analyzer were fit with third order polynomial regressions and all gave correlation coefficients of 0.995 or better.
In Vitro Heparin Sensitivity: The in vitro heparin sensitivity for SynthAFax and Activated THROMBOFAX APTT reagents was determined by performing a heparin response curve on the KoaguLab 60-S and ELECTRA 1600C using heparinized plasma dilutions at 0 to 0.5 units/ml. Heparin was added at the appropriate levels to a fresh normal plasma pool consisting of 10 normal donors. The slopes of the in vitro heparin response curve were equivalent for SynthAFax (113.9) and Activated THROMBOFAX (119.0) on the Koagulab 60-S, indicating equivalent sensitivity to heparinized plasma samples. On the ELECTRA 1600C the slopes were also equivalent for SynthAFax (86.9) and Activated THROMBOFAX (92.5).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient (Reagent Correlation Study): KoaguLab 60-S: 0.951, ELECTRA 1600C: 0.945
Slope (Reagent Correlation Study): KoaguLab 60-S: 1.08, ELECTRA 1600C: 1.15
Correlation Coefficient (Factor Assay Standard Curves): Koagulab 60-S: 0.988 to 0.997, ELECTRA 1600C: 0.997 to 1.000
Slope (In Vitro Heparin Sensitivity): Koagulab 60-S: SynthAFax 113.9, Activated THROMBOFAX 119.0; ELECTRA 1600C: SynthAFax 86.9, Activated THROMBOFAX 92.5.
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.
Activated THROMBOFAX® Reagent-Optimized
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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§ 864.7925 Partial thromboplastin time tests.
(a)
Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.(b)
Classification. Class II (performance standards).
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510(k) SUMMARY
APR 2 3 1996
| SUBMITTER: | Ortho Diagnostic Systems Inc.
1001 U.S. Hwy 202
Raritan, NJ 08869-0606 | CONTACT: | Ms. Blanche Chien
Tel: (908) 704-3920
Fax: (908) 218-8168 |
|--------------|------------------------------------------------------------------------------|------------|-----------------------------------------------------------------|
| DEVICE NAME: | SynthAFax™
APTT Reagent | PREDICATE: | Activated
THROMBOFAX®
Reagent-Optimized |
| DATE: | December 8, 1995 | | |
DEVICE DESCRIPTION:
SynthAFax APTT Reagent is a liquid buffered reagent which contains a blend of synthetic phospholipids formed in liposomes, and a soluble plasma activator, ellagic acid, for optimal activation of the contact phase of coagulation. The use of synthetic phospholipids assures uniformity in the reagent and lot-to-lot consistency.
The activated partial thromboplastin time (APTT) test uses an activating agent and a phospholipid source and calcium to optimally activate the intrinsic pathway of coagulation. SynthAFax is incubated with an anticoagulated plasma sample for a standard period of time, known as the contact activation time (CAT). SynthAFax initiates the contact phase of coagulation through the activation of Factor XII. The addition of calcium chloride allows for the binding of other coagulation factors to the phospholipid and subsequent activation of the coagulation cascade. The generation of thrombin eventually cleaves fibrinogen and activates Factor XIII which crosslinks the fibrin molecules to form a visible clot. This occurs within a specified period of time.
If there is a coagulation factor deficiency in the intrinsic pathway, the time required for the formation of the clot will be prolonged beyond that expected for normal plasma. There
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will also be a prolongation of clotting caused by the presence of an inhibitor or the anticoagulant effect of heparin.
INTENDED USE:
SynthAFax APTT Reagent is intended for the two-stage activated partial thromboplastin time (APTT) test, specific factor assays, APTT substitution test and monitoring heparin therapy.
TECHNOLOGICAL CHARACTERISTICS:
Both SynthAFax APTT Reagent and the predicate, Activated THROMBOFAX are used for activated partial thromboplastin time determinations for which they are well correlated and have equivalent precision. Both reagents are sensitive to plasma coagulation Factors I, II, V, VIII, IX, X, XI, XII, Prekallikrein, Kininogen, and acquired factor deficiencies cause by disseminated intravascular coagulation and liver disease. Both reagents are equally sensitive to lupus anticoagulants and to the anticoagulant effects of heparin therapy.
SynthAFax APTT Reagent is prepared from synthetic phospholipids of a consistent fatty acid make up and a known amount of each type of phospholipid. Activated THROMBOFAX is prepared from a phospholipid mixture extracted from bovine brain tissue and has a variety of fatty acid chain lengths and proportion of unsaturation.
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PERFORMANCE DATA:
Precision Study
The performance of SynthAFax APTT Reagent was evaluated at Ortho Diagnostic Systems, Inc., Raritan, NJ. The following data were derived from precision studies performed using both SynthAFax and Activated THROMBOFAX APTT Reagents and tested with ORTHO® Plasma Coagulation Control (OPCC) Level I (normal control), II and III (abnormal controls). The precision was tested on four different instruments to show the reagent equivalence independent of the instrument system.
TABLE 1: Precision Data
| OPCC Level I | Koagulab 60S | ELECTRA 1600 | ELECTRA 1400 | ELECTRA 1000 | ||||
|---|---|---|---|---|---|---|---|---|
| SynthAFax | Act. Throm. | SynthAFax | Act. Throm. | SynthAFax | Act. Throm. | SynthAFax | Act. Throm. | |
| Grand Mean (sec.) | ||||||||
| (n=180) | 25.0 | 24.5 | 22.7 | 22.7 | 22.4 | 23.0 | 23.0 | 22.9 |
| Replicate %CV | ||||||||
| (n=90) | 0.9 | 0.5 | 0.8 | 0.4 | 0.7 | 0.5 | 0.8 | 0.5 |
| Run to Run %CV | ||||||||
| (n=30) | 0.8 | 1.2 | 0.6 | 0.6 | 0.8 | 1.0 | 0.8 | 0.8 |
| Between Day %CV | ||||||||
| (n=5) | 0.6 | 0.5 | 0.3 | 0.5 | 0.8 | 0.6 | 0.7 | 0.7 |
| OPCC Level II | Koagulab 60S | ELECTRA 1600 | ELECTRA 1400 | ELECTRA 1000 | ||||
| SynthAFax | Act. Throm. | SynthAFax | Act. Throm. | SynthAFax | Act. Throm. | SynthAFax | Act. Throm. | |
| Grand Mean (sec.) | ||||||||
| (n=180) | 41.4 | 46.6 | 36.2 | 40.5 | 36.0 | 41.6 | 36.5 | 40.5 |
| Replicate %CV | ||||||||
| (n=90) | 0.9 | 0.6 | 0.8 | 0.5 | 0.7 | 0.4 | 0.7 | 0.7 |
| Run to Run %CV | ||||||||
| (n=30) | 1.1 | 1.4 | 0.6 | 0.7 | 1.1 | 1.1 | 1.1 | 1.0 |
| Between Day %CV | ||||||||
| (n=5) | 0.8 | 1.2 | 0.4 | 0.5 | 1.1 | 0.7 | 0.8 | 0.8 |
| OPCC Level III | Koagulab 60S | ELECTRA 1600 | ELECTRA 1400 | ELECTRA 1000 | ||||
| SynthAFax | Act. Throm. | SynthAFax | Act. Throm. | SynthAFax | Act. Throm. | SynthAFax | Act. Throm. | |
| Grand Mean (sec.) | ||||||||
| (n=180) | 54.5 | 61.9 | 47.9 | 53.4 | 47.2 | 53.4 | 46.9 | 54.3 |
| Replicate %CV | ||||||||
| (n=90) | 1.1 | 0.6 | 1.0 | 0.5 | 0.9 | 0.5 | 0.9 | 0.6 |
| Run to Run %CV | ||||||||
| (n=30) | 1.2 | 1.0 | 0.9 | 0.8 | 1.1 | 1.0 | 1.3 | 0.9 |
| Between Day %CV | ||||||||
| (n=5) | 0.9 | 0.9 | 0.7 | 0.5 | 1.1 | 0.6 | 1.0 | 0.8 |
SynthAFax versus Activated THROMBOFAX APTT Reagent
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Reagent Correlation Study
A total of one hundred (100) fresh normal donor plasma samples and seventy nine (79) frozen abnormal plasma samples from forty one (41) patients on heparin therapy, eleven (11) patients on oral anticoagulant therapy, three (3) patients with liver disease, and twenty four (24) lupus anticoagulant patients were tested for APTT with both SynthAFax and Activated THROMBOFAX APTT Reagents, using the KoaguLab 60-S Coagulation System and the ELECTRA 1600C. Data are shown in Figures 1 and 2 on the following page. For the KoaguLab 60-S, the correlation coefficient was 0.951, indicating acceptable correlation between the two reagents. The slope of the regression line was 1.08 indicating slightly more sensitivity for SynthAFax as compared to Activated THROMBOFAX APTT reagent. Similar results were seen on the ELECTRA 1600C.
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Image /page/4/Figure/0 description: The image contains two scatter plots comparing SynthAFax Clotting Times versus Activated THROMBOFAX Clotting Times. Figure 1 shows the correlation studies for Koagulab 60-S, with a correlation coefficient of 0.951, a slope of 1.08, and an intercept of -0.4. Figure 2 shows the correlation studies for ELECTRA 1600, with a correlation coefficient of 0.945, a slope of 1.15, and an intercept of -2.0. Both plots show a positive correlation between the two clotting time measurements, with data points representing patient samples.
Data From Reagent Correlation Studies
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Factor Assay Standard Curves
Factor VIII, IX, XI and XII Assay Standard Curves were performed with SynthAFax and Activated THROMBOFAX APTT Reagents on both the KoaguLab 60-S Coagulation System and ELECTRA 1600C. On the KoaguLab 60-S, the factor curve responsiveness was equivalent for Factors VIII, IX, XI, and XII compared to Activated THROMBOFAX, and all standard curves had correlation coefficients of 0.986 or better, indicating acceptable correlation. Factor curves on the ELECTRA 1600C analyzer were fit with third order polynomial regressions and all gave correlation coefficients of 0.995 or better.
| Koagulab 60-S | ELECTRA 1600C | ||||
|---|---|---|---|---|---|
| ORTHO | |||||
| SynthAFax | Activated | ||||
| THROMBOFAX | ORTHO | ||||
| SynthAFax | Activated | ||||
| THROMBOFAX | |||||
| Factor VIII | Slope | -0.130 | -0.108 | ||
| Y-Intercept | 1.823 | 1.829 | |||
| Corr. Coef. | 0.988 | 0.995 | 1.000 | 0.997 | |
| Factor IX | Slope | -0.129 | -0.104 | ||
| Y-Intercept | 1.803 | 1.820 | |||
| Corr. Coef. | 0.994 | 0.986 | 1.000 | 0.998 | |
| Factor XI | Slope | -0.173 | -0.173 | ||
| Y-Intercept | 1.996 | 1.996 | |||
| Corr. Coef. | 0.997 | 0.995 | 0.997 | 0.995 | |
| Factor XII | Slope | -0.239 | -0.288 | ||
| Y-Intercept | 2.021 | 2.215 | |||
| Corr. Coef. | 0.994 | 0.995 | 0.999 | 0.998 |
Data From Factor Assay Standard Curves
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In Vitro Heparin Sensitivity
The in vitro heparin sensitivity for SynthAFax and Activated THROMBOFAX APTT reagents was determined by performing a heparin response curve on the KoaguLab 60-S and ELECTRA 1600C using heparinized plasma dilutions at 0 to 0.5 units/ml. Heparin was added at the appropriate levels to a fresh normal plasma pool consisting of 10 normal donors. The slopes of the in vitro heparin response curve were equivalent for SynthAFax (113.9) and Activated THROMBOFAX (119.0) on the Koagulab 60-S, indicating equivalent sensitivity to heparinized plasma samples. On the ELECTRA 1600C the slopes were also equivalent for SynthAFax (86.9) and Activated THROMBOFAX (92.5)
Image /page/6/Figure/2 description: The image contains two line graphs comparing the clotting time versus Heparin concentration for two different devices, Koagulab 60-S and ELECTRA 1600C. Each graph plots two lines representing 'Activated THROMBOFAX' and 'SynthAFax'. For Koagulab 60-S, the slopes are 119.0 and 113.9 with correlation coefficients of 0.997 and 0.995, respectively, while for ELECTRA 1600C, the slopes are 92.5 and 88.9 with correlation coefficients of 0.999 and 0.997, respectively.
In Vitro Heparin Curves
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CONCLUSION
SynthAFax APTT Reagent is substantially equivalent to Activated THROMBOFAX Reagent-Optimized currently in commercial distribution by Ortho Diagnostic Systems Inc. as an activated partial thromboplastin time reagent used to determine deficiencies of clotting factor activity, either hereditary or acquired, in the intrinsic coagulation pathway or to monitor the effect of anticoagulant therapy.