(25 days)
P910006
Not Found
No
The description details a standard immunoenzymometric assay with no mention of AI or ML algorithms for data analysis or interpretation. The calculation of unknown sample concentrations is based on a standard curve, a traditional method.
No.
The device is an in vitro diagnostic (IVD) tool used for quantitative measurement of Alpha-Fetoprotein (AFP) in serum, which aids in patient management but does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Alpha-Fetoprotein (AFP) in serum to aid in the management of patients with nonseminomatous testicular carcinoma." This directly indicates its use for diagnostic purposes.
No
The device description clearly outlines a physical, in vitro diagnostic assay kit involving reagents, magnetic beads, and a fluorogenic substrate, indicating it is a hardware-based medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"ST AIA-PACK AFP is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Alpha-Fetoprotein (AFP) in serum to aid in the management of patients with nonseminomatous testicular carcinoma."
This statement clearly indicates that the device is intended for use in vitro (outside of the body) to diagnose or aid in the diagnosis or management of a medical condition.
N/A
Intended Use / Indications for Use
ST AIA-PACK AFP is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Alpha-Fetoprotein (AFP) in human serum on specific TOSOH AIA System analyzers.
Product codes (comma separated list FDA assigned to the subject device)
LOJ; JIS
Device Description
The ST AIA-PACK AFP is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. AFP present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AIA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the AFP concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
P910006
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for Tosoh Medics, Inc. The logo consists of a stylized four-leaf clover shape with a square in the center, followed by the text "TOSOH MEDICS, INC." The word "TOSOH" is also printed below the clover shape.
510(k) Summarv
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K023894
Submitter:
Tosoh Medics, Inc. 347 Oyster Point Blvd., Suite 201 South San Francisco, CA 94080 Phone: (650) 615-4970 Fax:
Contact Person:
Lois Nakayama Manager, Quality Assurance
Date of Summary Preparation:
Device Name:
Classification Name:
Predicate Device:
November 8, 2002
ST AIA-PACK AFP
Kit, Test, Alpha-fetoprotein for Testicular Cancer
Tosoh AIA-PACK AFP Tosoh Corporation Tokyo, Japan P910006
Device Description:
The ST AIA-PACK AFP is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. AFP present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AIA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbellifery| phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the AFP concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
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Statement of Intended Use:
ST AIA-PACK AFP is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Alpha-Fetoprotein (AFP) in human serum on specific TOSOH AIA System analyzers.
Substantial Equivalence:
This Special 510(k) is for a modification in the packaging, incubation period and certain components of the conjugate diluent of the AIA-PACK AFP, which was previously cleared as P910006 on December 18, 1992. The intended use, assay principles, antibody type, analyte detected, and performance characteristics of both assays are equivalent.
Conclusion:
The modified ST AIA-PACK AFP, as described in this Special 510(k) is substantially equivalent to the predicate device. The proposed modifications in packaging, incubation period and conjugate diluent are not substantial changes and do not affect the safety and effectiveness of the device.
Image /page/1/Picture/6 description: The image shows the TOSOH logo. The logo consists of a stylized black cross with rounded edges and a white square in the center. Below the symbol, the word "TOSOH" is printed in a simple, sans-serif font.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
d and Drug Administration
DEC 1 7 2002
Ms. Lois Nakavama Manager, Quality Assurance Tosoh Medics, Inc. 347 Oyster Point Blvd. - Suite 201 South San Francisco, CA 94080
Re: K023894 Trade/Device Name: ST AIA-PACK AFP Enzyme Immunoassay Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: LOJ; JIS Dated: November 20, 2002 Received: November 22, 2002
Dear Ms. Nakayama:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
,
、
| Device Name | ST AIA-PACK AFP Enzyme Immunoassay |
|---|---|
| Indications for | |
| Use | ST AIA-PACK AFP is designed for IN VITRO |
| DIAGNOSTIC USE ONLY for the quantitative | |
| measurement of Alpha-Fetoprotein (AFP) in | |
| serum to aid in the management of patients with | |
| nonseminomatous testicular carcinoma. |
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_V (Per 21CFR 801.109)
OR
Over-The-Counter Use______
I P. Reeves for S. Batista
ion Sian-Off) Division of Clinical Laboratory Devices
510(k) Number_16-23899