(295 days)
Not Found
No
The device description and performance studies focus on a direct measurement method based on electronic impedance and a simple calculation. There is no mention of AI/ML techniques, image processing, or training/test sets typically associated with such technologies.
No.
The device is described as an in vitro diagnostic screening assay used to measure platelet aggregation, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Plateletworks is an in vitro diagnostic screening assay."
No
The device description explicitly states it is a "unitized screening assay" that uses the "Ichor hematology analyzer" to measure platelet counts. This indicates the device includes hardware components (the analyzer and the assay itself), not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is an "in vitro diagnostic screening assay" for determining platelet aggregation in fresh whole blood samples.
- Device Description: The description details how the device analyzes a whole blood sample using an analyzer and reagents to measure a biological parameter (platelet aggregation) outside of the body.
- Sample Type: It uses "fresh whole blood samples," which are biological specimens.
- Purpose: The purpose is to provide information about a patient's physiological state (platelet function) for screening and potential further investigation.
These characteristics align directly with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures; as measured by a change in platelet count due to activation of functional platelets and is designed for use on the Ichor" hematology analyzer.
Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures as measured by a change in platelet count due to activation of functional platelets. It may be used at the point-of-care on the Ichor hematology analyzer as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.
Product codes (comma separated list FDA assigned to the subject device)
JOZ
Device Description
Plateletworks is a unitized screening assay for determining platelet aggregation in a whole blood sample using the Ichor hematology analyzer. The Plateletworks methodology is an adaptation of platelet aggregometry that is extremely simple, and quick to perform (results are available in about five minutes). This method involves using the Ichor hematology analyzer (based on electronic impedance principles) to measure total platelet count in a whole blood sample and then to redetermine the number of platelets in a second sample that has been exposed to a known platelet agonist. The agonist will stimulate those platelets which are functional to aggregate into clumps, and they will not be counted as platelets in the second sample. The difference in platelet counts between samples one and two provides a direct measurement of platelet aggregation and is reported as percent aggregation as per the following equation:
Baseline Platelet Count - Agonist Platelet Count x 100 = % Aggregation
Baseline Platelet Count
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
male and female adults, between the ages of 18 and 85
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)
Correlation of the Plateletworks assay to platelet aggregometry on platelet rich plasma (PRP) is supported by data generated by testing male and female adults, between the ages of 18 and 85, at three clinical sites. This includes healthy volunteers, patients undergoing cardiopulmonary bypass surgery, and patients undergoing cardiac catheterization.
All blood samples, for performing both Plateletworks assays and PRP aggregometry, were acquired from in-dwelling lines or venipuncture using established methods. For performing both the Plateletworks assays and PRP aggregometry, the manufacturers' recommendations were adhered to as per instructions provided in the package insert for each test system.
Regression analysis (correlation coefficients) was performed to assess the agreement between the two methods (i.e., Plateletworks and PRP aggregometry). Positive correlations were demonstrated for each agonist tested (ADP and collagen).
The data from the clinical sites where substantial equivalence testing was performed were also subjected to the non-parametric analyses of both Kendall Tau and Spearman Rho which "test for a positive correlation without specifying linearity". The results from these analyses are shown (with the regression analysis).
| N | (Pearson) r | Spearman Rho | Kendall Tau | |
|---|---|---|---|---|
| Collagen | 189 | 0.82* | 0.80* | 0.58* |
| ADP | 225 | 0.83* | 0.68* | 0.50* |
| *P |
§ 864.5700 Automated platelet aggregation system.
(a)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.(b)
Classification. Class II (performance standards).
0
510(k) Summary of Safety and Effectiveness Information Plateletworks™ Platelet Aggregation Assay
Array Medical, Inc. One Harvard Way, Suite 5 Hillsborough Campus Somerville, NJ 08876 (908)707-8872
Contact: David Carville, Ph.D., (908)707-8872; (219)237-4829
Date: June 25, 1999
Device Names:
Trade Name: Plateletworks
Common Name: Platelet Aggregation Assay
Classification Name: System, Automatic Platelet Aggregation
Legally Marketed Device:
Sigma Platelet Aggregation Reagents, K822733, K832929
Chrono-log Platelet Aggregometer, K77198, K830749, K851025
Device Description:
Plateletworks is a unitized screening assay for determining platelet aggregation in a whole blood sample using the Ichor hematology analyzer. The Plateletworks methodology is an adaptation of platelet aggregometry that is extremely simple, and quick to perform (results are available in about five minutes). This method involves using the Ichor hematology analyzer (based on electronic impedance principles) to measure total platelet count in a whole blood sample and then to redetermine the number of platelets in a second sample that has been exposed to a known platelet agonist. The agonist will stimulate those platelets which are functional to aggregate into clumps, and they will not be counted as platelets in the second sample. The difference in platelet counts between samples one and two provides a direct measurement of platelet aggregation and is reported as percent aggregation as per the following equation:
Baseline Platelet Count - Agonist Platelet Count x 100 = % Aggregation
Baseline Platelet Count
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Intended Use:
Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures; as measured by a change in platelet count due to activation of functional platelets and is designed for use on the Ichor" hematology analyzer.
Comparison with Predicate Device:
The Plateletworks Platelet Aggregation Assay is substantially equivalent to Sigma platelet aggregation reagents, previously cleared under Document Control # K822733 and K832929, used on the Chrono-log Platelet Aggregometer (Model 560-VS), previously cleared under Document Control # K771198, K830749 and K851025. These products are currently in commercial distribution by Sigma Diagnostics, St. Louis, MO and Chrono-log Corporation, Havertown, PA, respectively.
Substantial Equivalence:
Correlation of the Plateletworks assay to platelet aggregometry on platelet rich plasma (PRP) is supported by data generated by testing male and female adults, between the ages of 18 and 85, at three clinical sites. This includes healthy volunteers, patients undergoing cardiopulmonary bypass surgery, and patients undergoing cardiac catheterization.
All blood samples, for performing both Plateletworks assays and PRP aggregometry, were acquired from in-dwelling lines or venipuncture using established methods. For performing both the Plateletworks assays and PRP aggregometry, the manufacturers' recommendations were adhered to as per instructions provided in the package insert for each test system.
Regression analysis (correlation coefficients) was performed to assess the agreement between the two methods (i.e., Plateletworks and PRP aggregometry). Positive correlations were demonstrated for each agonist tested (ADP and collagen). See Figures 1 and 2
Image /page/1/Figure/9 description: This image is a scatter plot comparing PRP Aggregometer % Aggregation on the y-axis and Plateletworks % Aggregation on the x-axis. The plot includes a regression line with the equation y = 0.7743x + 1.3002 and an R-value of 0.83. The data points are clustered, showing a positive correlation between the two aggregation measurement methods, with most points concentrated in the higher percentage ranges.
Image /page/1/Figure/10 description: This image is a scatter plot comparing PRP Aggregometer % Aggregation and Plateletworks % Aggregation. The x-axis represents Plateletworks % Aggregation, while the y-axis represents PRP Aggregometer % Aggregation. The data points are scattered across the plot, showing the relationship between the two variables. A regression line is drawn through the data, and the equation of the line is y = 0.9224x + 2.1945, with an R-squared value of 0.82.
Image /page/1/Figure/11 description: The image shows the text "Figure 1. ADP". The text is in a serif font and is left-aligned. The number 1 is followed by a period.
Figure 2. Collagen
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However, it is recognized that correlation coefficients measure the strength of the relationship between the methods and not the agreement between them (Bland JM, Altman DG: Statistical methods for assessing agreement between two methods of clinical measurement. Lancet 1986;Feb:307-310.) Further, since the data for both aggregation systems are bounded by 100% as the upper limit of aggregation, regression analysis is not expected to describe a predictive relationship. Therefore, the data from the clinical sites where substantial equivalence testing was performed were also subjected to the non-parametric analyses of both Kendall Tau and Spearman Rho which "test for a positive correlation without specifying linearity". The results from these analyses are shown (with the regression analysis).
| N | (Pearson) r | Spearman Rho | Kendall Tau | |
|---|---|---|---|---|
| Collagen | 189 | 0.82* | 0.80* | 0.58* |
| ADP | 225 | 0.83* | 0.68* | 0.50* |
Comparative Data: Plateletworks vs. PRP Aggregometry
*P