(17 days)
The Access® AFP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein (AFP) in human serum using the Access Immunoassay System. AFP measured by the Access AFP Immunoassay, is used as an aid in the management of patients with nonseminomatous testicular cancer.
The ACCESS® AFP Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of AFP in human serum.
{
"acceptance_criteria_and_study": {
"table_of_performance": [
{
"criterion": "Correlation with Predicate Device (Abbott IMx AFP assay)",
"acceptance_criteria": "Not explicitly stated, but typically highly correlated (e.g., r > 0.95 and slope near 1, intercept near 0)",
"reported_performance": "r = 0.99; y = 0.91x + 3.86 (indicating very good agreement)"
},
{
"criterion": "Expected Range (Healthy individuals)",
"acceptance_criteria": "Typically, a high percentage of healthy individuals should fall within a defined reference range.",
"reported_performance": "98.9% of 177 healthy individuals had AFP values ≤ 9.0 ng/mL. 1.1% had values in the 9.1 to 15 ng/mL range."
},
{
"criterion": "Monitoring Data (Nonseminomatous Testicular Cancer Patients)",
"acceptance_criteria": "High concordance with predicate device results and concurrent clinical assessment in monitoring patient status.",
"reported_performance": "Results were highly concordant to both the IMx AFP results and concurrent clinical assessment."
},
{
"criterion": "Recovery (Linearity studies)",
"acceptance_criteria": "Typically a range of 90-110% recovery.",
"reported_performance": "96 to 110% recovery for diluted samples."
},
{
"criterion": "Recovery (Spiked samples)",
"acceptance_criteria": "Typically a range of 90-110% recovery.",
"reported_performance": "Average 99% recovery, with individual recoveries ranging from 90 to 108%."
},
{
"criterion": "Precision (Assay imprecision)",
"acceptance_criteria": "Typically less than a specified percentage (e.g.,
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.