VERIFYNOW-ASPIRIN ASSAY

K042423 · Accumetrics, Inc. · JOZ · Oct 6, 2004 · Hematology

Device Facts

• Record ID: K042423
• Device Name: VERIFYNOW-ASPIRIN ASSAY
• Applicant: Accumetrics, Inc.
• Product Code: JOZ · Hematology
• Decision Date: Oct 6, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5700
• Device Class: Class 2

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®).

Device Story

VerifyNow-Aspirin Assay; in vitro diagnostic device for assessment of platelet function. Input: whole blood sample. Transformation: agonist-induced platelet aggregation measured via optical detection; modified from cationic propyl gallate to arachidonic acid agonist; includes internal control. Output: quantitative platelet aggregation result. Used in clinical laboratory settings by trained personnel. Output assists clinicians in evaluating aspirin-induced platelet inhibition. Benefits: monitoring antiplatelet therapy efficacy.

Clinical Evidence

Multi-center clinical trial evaluated 136 subjects with vascular disease or risk factors. 71 subjects tested pre/post 325 mg aspirin; 65 subjects on chronic 81 mg aspirin therapy. Results compared to aspirin status using 550 ARU cutoff. Sensitivity: 91.4%; Specificity: 100%. Reference range for pre-aspirin samples: 620-672 ARU.

Technological Characteristics

Turbidimetric optical detection system. Assay device contains lyophilized fibrinogen-coated beads, arachidonic acid agonist, peptide, bovine serum albumin, buffer, and stabilizer. Stand-alone instrument performs automated sample mixing, temperature control, and optical measurement. Results reported in ARU.

Indications for Use

Indicated for qualitative detection of platelet dysfunction due to aspirin ingestion in citrated whole blood. Population: patients requiring assessment of aspirin effect. Contraindications: congenital platelet abnormalities, non-aspirin induced acquired platelet abnormalities, or patients receiving non-aspirin anti-platelet agents.

Regulatory Classification

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.

Predicate Devices

• Ultegra RPFA-ASA Assay (K012701)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER K_042423_VerifyNow-Aspirin_Assay

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. This is a modification of K012701 Ultegra RPFA-ASA Assay
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for In this Special 510(k) submission, the manufacturer modified the aggregation-inducing agent (agonist) in the assay device from cationic propyl gallate to arachidonic acid. They also added an internal control, changed the algorithm calculation, changed the buffer, and made some software modifications.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and

5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

(Reviewer's Signature) (Date)

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