(302 days)
Not Found
No
The description focuses on a turbidimetric optical detection system measuring light transmittance and does not mention any AI or ML components.
No
The device is a diagnostic tool designed to detect platelet dysfunction due to aspirin ingestion, not to treat or alleviate a medical condition.
Yes
The device is a qualitative test to aid in the detection of platelet dysfunction due to aspirin ingestion, which directly relates to diagnosing a physiological state.
No
The device description explicitly states the system consists of a "stand-alone analyzer and disposable test cartridge with reagents," indicating significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative test to aid in the detection of platelet dysfunction due to aspirin (ASA) ingestion in citrated whole blood". This involves testing a biological sample (whole blood) in vitro (outside the body) to provide information about a patient's health status (platelet function related to aspirin).
- Device Description: The description details a system that analyzes a patient sample (citrated whole blood) using reagents and a measurement system (turbidimetric based optical detection) to determine a result (Aspirin Reaction Units). This is characteristic of an in vitro diagnostic device.
- Sample Type: The device uses "citrated whole blood," which is a biological specimen.
- Testing Location: The intended use specifies "point of care or laboratory setting," which are typical locations for IVD testing.
- Performance Evaluation: The performance studies describe testing on patient samples to evaluate the device's ability to detect platelet dysfunction related to aspirin ingestion, a standard practice for validating IVDs.
All these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ultegra System Analyzer and RPFA-ASA Assay have been found to be substantially equivalent to previously cleared, automated platelet aggregation devices, specifically to CHRONO-LOG Corporation's Whole Blood Aggregometer (K830749).
The Ultegra® Rapid Platelet Function Assay-ASA (RPFA-ASA) is a whole blood assay used to measure platelet response to aspirin.
The Ultegra Rapid Platelet Function Assay-ASA (RPFA-ASA) is a qualitative test to aid in the detection of platelet dysfunction due to aspirin (ASA) ingestion in citrated whole blood for the point of care or laboratory setting.
Not for use in patients with underlying congenital platelet abnormalities, patients with non-ASA induced acquired platelet abnormalities or in patients receiving non-ASA anti-platelet agents (may be used in patients treated with selective COX-2 inhibitors, e.g., celecoxib (Celebrex®) and rofecoxib (Vioxx®)).
Product codes (comma separated list FDA assigned to the subject device)
JOZ
Device Description
The Ultegra System is a turbidimetric based optical detection system which measures platelet induced aggregation as an increase in light transmittance. The system consists of a stand-alone analyzer and disposable test cartridge with reagents based on microbead agglutination technology. The quality control system includes an electronic control and two levels of liquid control. The analyzer controls assay sequencing, establishes the assay temperature, controls the reagent-sample mixing for the required duration, determines the degree of platelet function, displays the results and status information to the user, and performs self-diagnostics.
The test cartridge contains a lyophilized preparation of human fibrinogen coated beads, platelet agonist, buffer, and preservative. The patient sample is citrated whole blood, which is automatically dispensed from the blood collection tube into the test cartridge by the analyzer, with no blood handling required by the user. Fibrinogen-coated microparticles are used in the Ultegra RPFA-ASA cartridge to bind to available platelet receptors. When the activated platelets are exposed to the fibringgen-coated microparticles, agglutination occurs in proportion to the number of available platelet receptors. To ensure consistent and uniform activation of the platelets, cationic propyl gallate (c-PG) is incorporated into the assay cartridge to induce platelet activation without fibrin formation. The Ultegra Analyzer is designed to measure this agglutination as an increase in light transmittance. Utregra RPFA-ASA Assay results are reported as Aspirin Reaction Units (ARU).
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
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Intended User / Care Setting
point of care or laboratory setting.
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
The Ultegra RPFA-ASA performance was evaluated in a multi-center clinical trial on venous whole blood samples from subjects with history of vascular disease or existence of at least two of eight risk factors for developing vascular disease.
The multi-center clinical trial was designed to study results from patients before and after aspirin ingestion (325 mg). Samples were obtained at four clinical sites from 148 patients at two time points: 1) Pre-ASA, prior to aspirin ingestion and 2) Post-ASA, 2 to 30 hours after ingestion of aspirin. Samples were tested in duplicate with the Ultegra RPFA-ASA Assay and compared to the patient's aspirin status. RPFA-ASA results were based on a designated cutoff of 550 ARU (extent of platelet aggregation measured).
Testing was performed on patients newly introduced to aspirin. Ultegra RPFA-ASA was evaluated against the presence and absence of aspirin ingestion.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Ultegra RPFA-ASA performance was evaluated in a multi-center clinical trial on venous whole blood samples from subjects with history of vascular disease or existence of at least two of eight risk factors for developing vascular disease.
The multi-center clinical trial was designed to study results from patients before and after aspirin ingestion (325 mg). Samples were obtained at four clinical sites from 148 patients at two time points: 1) Pre-ASA, prior to aspirin ingestion and 2) Post-ASA, 2 to 30 hours after ingestion of aspirin. Samples were tested in duplicate with the Ultegra RPFA-ASA Assay and compared to the patient's aspirin status. RPFA-ASA results were based on a designated cutoff of 550 ARU (extent of platelet aggregation measured).
Testing was performed on patients newly introduced to aspirin. Ultegra RPFA-ASA was evaluated against the presence and absence of aspirin ingestion. The concordance table below illustrates performance results.
| TEST RESULT | ASA STATE | |
|---|---|---|
| PRESENT (n=143) | ABSENT (n=140) | |
| POSITIVE (= 550 ARU) | 11 | 122 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
ASA Present:
Sensitivity = 92.1% (86.4% to 96.0%)
Specificity = 85.3% (78.4% to 90.7%)
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.
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
§ 864.5700 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
JUN 1 2 2002
510(k) Summary
Accumetrics Ultegra® System Rapid Platelet Function Assay -ASA (RPFA-ASA)
Accumetrics 3985 Sorrento Valley Blvd. San Diego, CA 92121
June 6, 2002
For information regarding this 510(k) Summary, please contact Rhonda Moe at Accumetrics, (858) 643-1600.
Device Names:
Trade Name:
Ultegra System Analyzer, Ultegra System Rapid Platelet Function Assay-ASA (RPFA-ASA) Test Cartridges, RPFA Level One QC.and RPFA Level Two QC
Common Name:
Ultegra Analyzer, Ultegra RPFA-ASA Test Cartridges, RPFA Level One QC and RPFA Level Two QC
Classification Name: System, Automated Platelet Aggregation
The Accumetrics Ultegra System Analyzer and RPFA-ASA Assay have been found to be substantially equivalent to previously cleared, automated platelet aggregation devices, specifically to CHRONO-LOG Corporation's Whole Blood Aggregometer (K830749).
Device Description:
The Ultegra System is a turbidimetric based optical detection system which measures platelet induced aggregation as an increase in light transmittance. The system consists of a stand-alone analyzer and disposable test cartridge with reagents based on microbead agglutination technology. The quality control system includes an electronic control and two levels of liquid control. The analyzer controls assay sequencing, establishes the assay temperature, controls the reagent-sample mixing for the required duration, determines the degree of platelet function, displays the results and status information to the user, and performs self-diagnostics.
The test cartridge contains a lyophilized preparation of human fibrinogen coated beads, platelet agonist, buffer, and preservative. The patient sample is citrated whole blood, which is automatically dispensed from the blood collection tube into the test cartridge by the analyzer, with no blood handling required by the user. Fibrinogen-coated microparticles are used in the Ultegra RPFA-ASA cartridge to bind to available platelet receptors. When the activated platelets are exposed to the fibringgen-coated microparticles, agglutination occurs in proportion to the number of available platelet receptors. To ensure consistent and uniform activation of the platelets, cationic propyl gallate (c-PG) is incorporated into the assay cartridge to induce platelet
1
activation without fibrin formation. The Ultegra Analyzer is designed to measure this agglutination as an increase in light transmittance. Utregra RPFA-ASA Assay results are reported as Aspirin Reaction Units (ARU).
Intended Use:
The Ultegra Rapid Platelet Function Assay-ASA (RPFA-ASA) is a qualitative test to aid in the detection of platelet dysfunction due to aspirin (ASA) ingestion in citrated whole blood for the point of care or laboratory setting.
Not for use in patients with underlying congenital platelet abnormalities, patients with non-ASA induced acquired platelet abnormalities or in patients receiving non-ASA anti-platelet agents (may be used in patients treated with selective COX-2 inhibitors, e.g., celecoxib (Celebrex®) and rofecoxib (Vioxx®)).
This intended use statement is more specific than the broader statement in the labeling for the CHRONO-LOG Whole Blood Aggregometer: " ... measuring platelet aggregation in whole blood or platelet rich plasma." The narrower indication of the Ultegra RPFA-ASA Assay does not raise issues of safety or effectiveness since the CHRONO-LOG aggregometer contains data in its labeling regarding results after aspirin ingestion.
Technological Characteristics:
The Ultegra Analyzer and the CHRONO-LOG aggregometer utilize optical detection as the measurement method. Both systems are based on measurement of aggregation/agglutination. Both systems are used to determine platelet function.
Certain new characteristics of the Ultegra RPFA-ASA differ from the CHRONO-LOG. Fibringen coated microbeads are used in the Ultegra RPFA-ASA Assay, but not the CHRONO-LOG aggregometer. The Ultegra RPFA-ASA Assay uses the agonist cationic propyl gallate, whereas the CHRONO-LOG uses several different agonists. The Ultegra RPFA-ASA Assay includes two levels of liquid control, and the CHRONO-LOG does not.
These differences raise no new issues of safety or effectiveness, as shown by the performance characteristics of the two devices.
Performance Characteristics:
The Ultegra RPFA-ASA performance was evaluated in a multi-center clinical trial on venous whole blood samples from subjects with history of vascular disease or existence of at least two of eight risk factors for developing vascular disease.
The multi-center clinical trial was designed to study results from patients before and after aspirin ingestion (325 mg). Samples were obtained at four clinical sites from 148 patients at two time points: 1) Pre-ASA, prior to aspirin ingestion and 2) Post-ASA, 2 to 30 hours after ingestion of aspirin. Samples were tested in duplicate with the Ultegra RPFA-ASA Assay and compared to the patient's aspirin status. RPFA-ASA results were based on a designated cutoff of 550 ARU (extent of platelet aggregation measured).
2
Testing was performed on patients newly introduced to aspirin. Ultegra RPFA-ASA was evaluated against the presence and absence of aspirin ingestion. The concordance table below illustrates performance results.
| TEST RESULT | ASA STATE | |
|---|---|---|
| PRESENT (n=143) | ABSENT (n=140) | |
| POSITIVE | ||
| ( |