(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., <10%, <15%).",
"reported_performance": "<6% for AFP concentrations from 6.5 to 1680 ng/ml."
},
{
"criterion": "Specificity",
"acceptance_criteria": "No significant interference from potential biological substances, therapeutic drugs, or cross-reacting substances.",
"reported_performance": "No significant interference."
},
{
"criterion": "Analytical Sensitivity (Lowest detectable level)",
"acceptance_criteria": "A specific low concentration value that is distinguishable from zero with a high confidence level.",
"reported_performance": "0.5 ng/ml (distinguishable from zero with 95% confidence)."
}
],
"sample_size_test_set_and_data_provenance": {
"correlation_study": {
"sample_size": "170 samples",
"data_provenance": "Not specified (retrospective or prospective, country of origin not mentioned)."
},
"expected_range_study": {
"sample_size": "177 apparently healthy males and females",
"data_provenance": "Not specified (retrospective or prospective, country of origin not mentioned)."
},
"monitoring_data_study": {
"sample_size": "Longitudinal samples from previously diagnosed nonseminomatous testicular cancer patients (number not specified)",
"data_provenance": "Not specified (retrospective or prospective, country of origin not mentioned)."
},
"recovery_studies": {
"sample_size": "Not specified (number of human serum samples or spiked samples)",
"data_provenance": "Not specified."
},
"precision_study": {
"sample_size": "Not specified (number of samples tested for precision)",
"data_provenance": "Not specified."
},
"specificity_study": {
"sample_size": "Not specified (number of substances/drugs tested)",
"data_provenance": "Not specified."
},
"analytical_sensitivity_study": {
"sample_size": "Not specified",
"data_provenance": "Not specified."
}
},
"ground_truth_experts_test_set": {
"correlation_monitoring_expected_range": "Not applicable, as these studies primarily compared measurements against a predicate device or established reference ranges, not against a new 'ground truth' established by experts in the context of image analysis, for example.",
"qualifications": "Not applicable."
},
"adjudication_method_test_set": "Not applicable, as this is a quantitative immunoassay and not reliant on expert review of ambiguous cases.",
"mrmc_comparative_effectiveness_study": "No, this is an in-vitro diagnostic device for quantitative measurement of alpha-fetoprotein (AFP) and not an imaging device or algorithm requiring human reader interpretation or assistance. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not relevant.",
"standalone_performance_study": "Yes, all the described studies (correlation, expected range, monitoring data, recovery, precision, specificity, analytical sensitivity) demonstrate the standalone performance of the ACCESS® AFP Immunoassay. The assay directly measures AFP levels in serum.",
"type_of_ground_truth_used": {
"correlation_study": "The Abbott IMx AFP assay (predicate device) served as the reference for comparison.",
"expected_range_study": "Statistical distribution of AFP values in an 'apparently healthy' population.",
"monitoring_data_study": "Abbott IMx AFP assay results and 'concurrent clinical assessment' provided the reference for concordance.",
"recovery_precision_specificity_analytical_sensitivity": "Defined analytical standards, known spiked concentrations, and reference materials were used."
},
"sample_size_training_set": "Not applicable, as this is a chemical immunoassay, not a machine learning model that requires a training set in the conventional sense. The 'training' for the assay involves internal calibration and reagent optimization by the manufacturer.",
"ground_truth_training_set_establishment": "Not applicable for the reasons stated above. The immunoassay itself is based on chemical reactions and detection, not a learned algorithm from a training dataset."
}
}
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness
- General Information
Device Generic Name:
Device Trade Name:
Applicant's Name and Address:
Alpha-fetoprotein (AFP) Immunological Test System for the Management of Nonseminomatous Testicular Cancer
ACCESS® AFP Assay
Beckman Instruments, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Date:
April 13, 1998
2. Predicate Device Abbott IMx AFP Immunofluorometric Assay Abbott Laboratories One Abbott Park Road Abbott Park, IL 60064-3500
PMA Number: P820060
3. Device Description
The ACCESS® AFP Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of AFP in human serum.
4. Indications for Use
The ACCESS AFP Immunoassay 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 intended for use as an aid in the management of patients with nonseminomatous testicular cancer.
5. Comparison of Technological Characteristics
Both the ACCESS AFP Immunoassay and the Abbott IMx AFP assay quantitatively measure serum AFP by means of simultaneous immunoassays utilizing the binding of AFP to monoclonal antibodies specific to epitopes on the AFP molecule. Both systems utilize liquid multi-point calibrators.
The ACCESS AFP Immunoassay Reagents are designed for use on the ACCESS Immunoassay Analyzer, a fully automated random access system, while the Abbott IMx AFP assay is a batch mode system. The ACCESS Immunoassay Analyzer uses magnetic particle solid phase enzyme immunoassays with chemiluminescent detection, while the Abbott IMx AFP assay uses a glass fiber solid phase and fluorescent detection. The Access AFP assay can measure samples with AFP concentrations up to 3000 ng/ml without prior dilution while the IMx AFP assay requires dilution of samples with AFP concentrations of greater than 350 ng/ml. The ACCESS Immunoassay Analyzer stores reagents on board for up to 24 different analytes and has 28 day calibration curve stability, while Abbott IMx AFP assay is an individual analyte reagent kit.
6. -Summary of Studies
Correlation: A comparison of AFP values from 170 samples, ranging from 0,90 to 3000 ng/ml, run with both the ACCESS AFP Immunoassay and the Abbott IMx AFP assay demonstrated very good agreement with the following statistical data: r = 0.99; y = 0.91x + 3.86.
{1}------------------------------------------------
Expected Range: In a population of 177 apparently healthy males and females, 98.9% had AFP values of 9.0 ng/mL or less, with the remaining 1.1% having values in the 9.1 to 15 ng/mL range.
Monitoring Data: Longitudinal samples from previously diagnosed nonseminomatous testicular cancer patients were compared using the ACCESS AFP and Abbott IMx AFP assays. The monitoring patient data demonstrate that the ACCESS AFP results are highly concordant to both the IMX AFP results and the concurrent clinical assessment.
Recovery: Linearity studies performed by diluting human serum samples with ACCESS AFP Sample Diluent provided recoveries ranging from 96 to 110%. Recovery of exogenous AFP (from cord serum) spiked into serum samples resulted in an average recovery of 99%, with individual recoveries ranging from 90 to 108%.
Precision: The ACCESS AFP assay exhibits assay imprecision of less than 6% for AFP concentrations ranging from approximately 6.5 to 1680 ng/ml.
Specificity: There was no significant interference from potential biological substances. therapeutic drugs or other cross-reacting substances.
Analytical Sensitivity: The lowest detectable level of AFP distinguishable from zero (ACCESS AFP Calibrator S0) with 95% confidence is 0.5 ng/ml.
7. Conclusion
The ACCESS AFP Immunoassay Reagents, when used in conjunction with the ACCESS Immunoassay Analyzer, are substantially equivalent to another commercially available immunoassay for the measurement of serum AFP. The ACCESS AFP Immunoassay is appropriate for monitoring patients with nonseminomatous testicular cancer.
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows a partial logo of what appears to be a government department. The logo features a stylized, abstract design with curved lines, possibly representing a symbol or emblem. The word "DEPARTMENT" is partially visible along the left edge of the image, oriented vertically. The overall impression is that of an official or bureaucratic entity.
1 1998 MAY
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Ellen Voss Requlatory Affairs Beckman Instruments, Inc. 1000 Lake Hazeltine Drive Chaska, Minnesota 55318
Re : K981354 ACCESS® AFP Assay Trade Name: Requlatory Class: II Product Code: LOJ Dated: April 13, 1998 Received: April 14, 1998
Dear Ms. Voss:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth General ... in the Quality System Regulation (QS) for Medical Devices: regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
{3}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
INDICATIONS FOR USE STATEMENT
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name: ACCESS® AFP
Indications For Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Makurin
(Division Sign-Off)
Division of Clinical Laboratory Devices K981354
510(k) Number
1886年9964488888498494949446877-4444744444444444444444444444444444444444444444444444444444444
1 Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use_
(Optional Format 1-2-96)
§ 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.