(135 days)
The AggreGuide A-100 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 years of age or older in 3.2% citrated venous whole blood using the AggreGuide A-100 instrument. For professional use. This test 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. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician.
The AggreGuide A-100 is a laser light scattering system that detects the level of platelet aggregation induced by arachidonic acid agonist in whole blood in motion. The system consists of an instrument and a disposable assay cartridge with pre-loaded freeze dried agonist. A whole blood sample is added to a disposable cartridge that is preloaded with freeze dried arachidonic acid agonist (AA) in a reaction chamber for an individual test. The amount of platelet aggregation is measured by detecting the laser light scattering caused by platelet aggregates. Aspirin is known to inhibit the level of platelet aggregation, or activity, when blood is mixed with arachidonic acid.
My apologies, but this document does not contain the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them, especially in the context of a conventional medical device study (e.g., diagnostic accuracy, comparative effectiveness).
Here's why and what the document does provide:
Why the requested information is not present:
- This is a 510(k) Substantial Equivalence Submission for MODIFICATIONS, not an original submission or a study report. The document details changes made to an already cleared device (K122162). Its purpose is to demonstrate that the modified device is still substantially equivalent to the original, cleared device, and that the modifications do not raise new questions of safety or effectiveness.
- The document focuses on verification and validation of changes: The "Summary of Performance Data" (Section 7) explicitly states that "The risk analysis method used to assess the impact of the modifications was ISO 14971:2007, 'Medical devices -- Application of risk management to medical devices'." It then lists results for specific changes: laser diode part replacement, QC2 implementation, software updates, shelf life extension, and User's Manual revision.
- No clinical performance data was collected for this submission: Section 8 explicitly states, "The modifications did not require collection of clinical performance data." This directly contradicts the need for most of the information you asked for (e.g., sample size for test set, ground truth, expert adjudication, MRMC studies, standalone performance).
What the document does provide (related to your request, but not directly answering it):
- Device Name: AggreGuide A-100 AA assay, AggreGuide A-100 Instrument
- Indications for Use: "The AggreGuide A-100 AA Assay is a qualitative system to aid in the detection of platelet dysfunction due to aspirin ingestion by those 18 years of age or older in 3.2% citrated venous whole blood using the AggreGuide A-100 instrument. For professional use. This test 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. The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician."
- Predicate Device: AggreGuide A-100 AA assay and AggreGuide A-100 Instrument, 510(k) document number K122162.
- Specific Modifications:
- Laser Diode Part: Changed from Sanyo DL-4140-001S to QSI QL7816SA-L
- Quality Control Cartridge: Modified to QC2 cartridge
- Software: Updated from Version 4.91 to Version 5.10
- Test Cartridge Shelf Life: Extended from 12 months to 18 months
- User's Manual: Revised from LBL-0014-C to LBL-0014-E
Given this, I cannot fill in the table or provide the specific details you requested because the document is a regulatory submission for changes to an existing device, and clinical performance data was explicitly not required for this submission. The "acceptance criteria" discussed are related to the successful verification and validation of these specific hardware/software/shelf-life changes, not the overall diagnostic accuracy of the device against a clinical ground truth.
If you had a document for the original 510(k) clearance (K122162), it might contain some of the performance data you're looking for, but this particular document does not.
§ 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).