(16 days)
Not Found
No
The summary describes a quality control material for an immunoassay system, not a device that processes data or images using AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
Explanation: The device is described as a control for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein. It is used for diagnostic purposes (monitoring performance of an assay), not for treating a disease or condition.
No
Explanation: The device is described as "tri-level controls intended for use in monitoring system performance of immunoenzymatic procedures." This indicates it's a quality control product used to ensure the accuracy and reliability of diagnostic tests, rather than performing the diagnosis itself. It helps to ensure the diagnostic device is working correctly, it's not a diagnostic device itself.
No
The device description clearly states the controls consist of human AFP in human serum with preservatives, indicating a physical, biological component, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay System." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: The description mentions it consists of "human AFP in human serum," which is a biological sample used in laboratory testing.
- Function: Controls are a fundamental component of IVD testing, used to ensure the accuracy and reliability of the assay being performed on patient samples.
Therefore, based on the provided information, the Access® AFP QC is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access® AFP QC (serum based) are tri-level controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay System.
Product codes
JJX
Device Description
The Access AFP QC are tri-level controls consisting of human AFP in human serum with preservatives. They are targeted to cover the assay range of approximately 7.0 ng/ml to 1725 ng/ml. with the controls targeted at 7, 80 and 1725 na/ml.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Within-run, between-run and total imprecision of all three levels of the Access AFP QC were less than 5% CV. Access AFP QC are stable for up to 13 months when stored at 2-8° C
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
JUN 12 1998
510(k) Summary of Safety and Effectiveness
1. General Information Device Generic Name:
Single (Specified) Analyte Controls, Assayed Control
Device Trade Name:
Applicant's Name and Address:
Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
Submission Date:
May 26, 1998
Access AFP QC
Predicate Device 2.
Lyphochek@ Immunoassay Control Serum Bio-Rad Laboratories 3726 E. Miraloma Avenue Anaheim, CA 92806
510(k) Number: K891475
3. Device Description
The Access AFP QC are tri-level controls consisting of human AFP in human serum with preservatives. They are targeted to cover the assay range of approximately 7.0 ng/ml to 1725 ng/ml. with the controls targeted at 7, 80 and 1725 na/ml.
Indications for Use 4.
The Access AFP QC are controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay System.
5. Comparison of Technological Characteristics
The Access AFP QC and the Lyphochek Immunoassay Controls are both tri-level, human serum-based immunoassay controls intended to monitor the system performance of immunoassays for the measurement of AFP in human serum.
The Access AFP QC, intended for use with the Access AFP Reagents on the Access Immunoassay System are provided ready to use with an approximate range of 7.0 to 1725 ng/ml. The Lyphochek Immunoassay Controls, not designed for a specific immunoassay system, have approximate range of 30 to 280 ng/ml, depending on the assay used and require reconstitution.
6. Summary of Studies
Within-run, between-run and total imprecision of all three levels of the Access AFP QC were less than 5% CV. Access AFP QC are stable for up to 13 months when stored at 2-8° C
7. · Conclusion
The Access AFP QC tri-level control materials are substantially equivalent to the Lyphochek Immunoassay Controls for the determination of system performance of AFP immunoassays based on similar features and reproducible results.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the circle. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN / 2 1998
Ellen M. Voss, M.S. Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
Re : K981864 ACCESS® AFP QC on the ACCESS® Immunoassay Analyzer Regulatory Class: I Product Code: JJX May 26, 1998 Dated: May 27, 1998 Received:
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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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.
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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 regulation 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Gutman
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
3
INDICATIONS FOR USE STATEMENT
1 of 1 Page ___
510(k) Number (if known):
Device Name: ACCESS® AFP QC
Indications For Use:
The Access® AFP QC (serum based) are tri-level controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay System.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K981864