(29 days)
NotFound
No
The description details a turbidimetric optical detection system measuring platelet aggregation based on light transmittance and microbead agglutination technology. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or decision-making. The results are based on a designated cutoff value.
No
The device is a qualitative assay used to detect platelet dysfunction due to aspirin ingestion, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is described as a qualitative assay to aid in the detection of platelet dysfunction due to aspirin ingestion, which directly supports making a diagnosis related to a patient’s physiological state. It also evaluates performance using sensitivity and specificity, which are metrics commonly used for diagnostic devices.
No
The device description clearly states the system consists of a "stand-alone instrument and disposable assay device with reagents based on microbead agglutination technology," 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 assay to aid in the detection of platelet dysfunction due to aspirin 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 condition (platelet dysfunction related to aspirin).
- Device Description: The description details a system that analyzes a patient sample (citrated whole blood) using reagents and a measurement technique (turbidimetry) 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 sample taken from a patient.
- Purpose: The purpose is to "aid in the detection of platelet dysfunction," which is a diagnostic purpose.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The VerifyNow-Aspirin Assay is a qualitative assay to aid in the detection of platelet dysfunction due to aspirin inqestion in citrated whole blood for the point of care or laboratory setting.
This assay is not for use in patients with underlying congenital platelet abnormalities, patients with non-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin anti-platelet agents (may be used in patients treated with selective COX-2 inhibitors, e.g., celecoxib (Celebrex®) and rofecoxib (Vioxx®).
Product codes
JOZ
Device Description
The VerifyNow 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 instrument and disposable assay device with reagents based on microbead agglutination technology. The quality control system includes an electronic quality control, an assay device internal control, and two levels of external, wet quality control controls. The instrument controls assay sequencing, establishes the assay temperature, controls the reagentsample 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 assay device contains a lyophilized preparation of human fibrinogen coated beads, platelet agonist, a peptide, bovine serum albumin, buffer, and stabilizer. The patient sample is citrated whole blood, which is automatically dispensed from the blood collection tube into the assay device by the instrument, with no blood handling required by the user. Fibrinogen-coated microparticles are used in the VerifyNow-Aspirin assay device to bind activated platelet GP IIb/Ila receptors. When the activated platelets are exposed to the fibrinogen-coated microparticles, aggregation occurs in proportion to the number of activated platelet receptors. To ensure consistent and uniform activation of the platelets, the agonist arachidonic acid is incorporated into the assay device. The VerifyNow-Aspirin Assay reports results in 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
Not Found
Intended User / Care Setting
point of care or laboratory setting
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
The VerifyNow-Aspirin Assay performance was evaluated in a multi-center clinical trial on venous whole blood samples from subjects with a history of vascular disease or existence of at least two of eight risk factors for developing vascular disease. Two aspirin ingestion schemes were studied. Seventy-one of the study's 136 subjects were tested before and after ingestion of 325 mg of aspirin. The remaining 65 subjects were on chronic aspirin therapy of 81 mg per day and were tested at a single post-aspirin time point. Samples were tested with the VerifyNow-Aspirin Assay and results were compared to the patient's aspirin status. VerifyNow-Aspirin Assay results were reported as positive or negative, based on a designated cutoff of 550 ARU. The VerifyNow-Aspirin Assay was evaluated against the presence and absence of aspirin ingestion.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Trial: The VerifyNow-Aspirin Assay performance was evaluated in a multi-center clinical trial on venous whole blood samples from subjects with a history of vascular disease or existence of at least two of eight risk factors for developing vascular disease. 136 subjects participated. Samples were tested with the VerifyNow-Aspirin Assay and results were compared to the patient's aspirin status. VerifyNow-Aspirin Assay results were reported as positive or negative, based on a designated cutoff of 550 ARU. The VerifyNow-Aspirin Assay was evaluated against the presence and absence of aspirin ingestion.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity = 91.4%
Specificity = 100%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters that appear to be handwritten. The sequence starts with the letters 'K0', followed by the numbers '424', and ends with the number '33'. The characters are written in a dark ink, and the handwriting style is somewhat cursive.
510(k) Summary
Accumetrics VerifyNow-Aspirin Assay (Formerly Ultegra RPFA-ASA)
Accumetrics 3985 Sorrento Vallev Blvd. San Diego, CA 92121
September 3, 2004
For information regarding this 510(k) Summary, please contact Accumetrics, Barbara Stevens (858) 643-1600.
Device Names:
| Trade Name: | VerifyNow-Aspirin Assay |
|---|---|
| Common Name: | VerifyNow-Aspirin Assay |
| Comprised of: | VerifyNow-Aspirin Assay Devices |
| VerifyNow Wet Quality Controls, Levels 1 and 2 | |
| VerifyNow Instrument |
Classification Name: System, Automated Platelet Aggregation
The Accumetrics VerifyNow System and VerifyNow-Aspirin 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 VerifyNow 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 instrument and disposable assay device with reagents based on microbead agglutination technology. The quality control system includes an electronic quality control, an assay device internal control, and two levels of external, wet quality control controls. The instrument controls assay sequencing, establishes the assay temperature, controls the reagentsample 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 assay device contains a lyophilized preparation of human fibrinogen coated beads, platelet agonist, a peptide, bovine serum albumin, buffer, and stabilizer. The patient sample is citrated whole blood, which is automatically dispensed from the blood collection tube into the assay device by the instrument, with no
1
blood handling required by the user. Fibrinogen-coated microparticles are used in the VerifyNow-Aspirin assay device to bind activated platelet GP IIb/Ila receptors. When the activated platelets are exposed to the fibrinogen-coated microparticles, aggregation occurs in proportion to the number of activated platelet receptors. To ensure consistent and uniform activation of the platelets, the agonist arachidonic acid is incorporated into the assay device. The VerifyNow-Aspirin Assay reports results in Aspirin Reaction Units (ARU).
Intended Use:
The VerifyNow-Aspirin Assay is a qualitative assay to aid in the detection of platelet dysfunction due to aspirin inqestion in citrated whole blood for the point of care or laboratory setting.
This assay is not for use in patients with underlying congenital platelet abnormalities, patients with non-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin 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 VerifyNow-Aspirin Assay does not raise issues of safety or effectiveness since the aggregometer labeling includes platelet aggregation data for samples post-aspirin ingestion.
Technological Characteristics:
The VerifyNow-Aspirin Assay is similar to the CHRONO-LOG Optical Aggregometer in that it employs an optical measurement method. Whereas the CHRONO-LOG Whole Blood Aggregometer measures impedance, it has been found to be substantially equivalent to the optical detection version of the aggregometer. The VerifyNow-Aspirin Assay is similar to the CHRONO-LOG Whole Blood Aggregometer in that it uses citrated, whole blood samples and measures platelet aggreaation. The platelet agonist for the VerifyNow-Aspirin Assay is arachidonic acid, which is also an agonist used with the optical and whole blood aggregometers. The VerifyNow-Aspirin Assay adds the use of fibrinogen-coated microparticles, which are not used in the CHRONO-LOG aggregometry methods. This difference raises no new issues of safety or effectiveness, as shown by the performance characteristics of the two devices.
Performance Characteristics:
The VerifyNow-Aspirin Assay performance was evaluated in a multi-center clinical trial on venous whole blood samples from subjects with a history of vascular disease or existence of at least two of eight risk factors for developing vascular disease.
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Two aspirin ingestion schemes were studied. Seventy-one of the study's 136 subjects were tested before and after ingestion of 325 mg of aspirin. The remaining 65 subjects were on chronic aspirin therapy of 81 mg per day and were tested at a single post-aspirin time point. Samples were tested with the VerifyNow-Aspirin Assay and results were compared to the patient's aspirin status. VerifyNow-Aspirin Assay results were reported as positive or negative, based on a designated cutoff of 550 ARU. The VerifyNow-Aspirin Assay was evaluated against the presence and absence of aspirin ingestion. The concordance table below illustrates performance results.
| Test Result | Aspirin State | |
|---|---|---|
| Present | Absent | |
| Positive | ||
| ( Trade/Device Name: VerifyNow™- Aspirin Assay (Modification to Ultegra® RPFA-ASA Assay) Regulation Number: 21 CFR 864.5700 Regulation Name: Automated platelet aggregation system Regulatory Class: Class II Product Code: JOZ Dated: September 3, 2004 Received: September 7, 2004 |
Dear Ms. Stevens:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042423
VerifyNow™-Aspirin Assay (Modification to Ultegra® RPFA-ASA Assay) Device Name:
Indications For Use:
The VerifyNow Aspirin Assay is a qualitative assay to aid in the detection of platelet dysfunction due to aspirin ingestion in citrated whole blood for the point of care or laboratory setting.
This assay is not for use in patients with underlying congenital platelet abnormalities, patients with non-aspirin induced acquired platelet abnormalities or in patients receiving non-aspirin anti-platelet agents (may be used in patients treated with selective COX-2 inhibitors, e.g., celecoxib (Celebrex®) and rofecoxib (Vioxx®).
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aurghim Bautista
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042423
0009