(25 days)
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.
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.
The provided text is a 510(k) summary for the ST AIA-PACK AFP device, which is an in vitro diagnostic for measuring Alpha-Fetoprotein (AFP) in human serum. This submission is a "Special 510(k)" for a modification to an already cleared device (P910006).
Based on the information provided in the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document states: "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."
This statement implies that the acceptance criteria for the modified device are the same as those established for the original P910006 device and that the modified device's performance is equivalent to the predicate. However, the document does not explicitly list the acceptance criteria (e.g., specific thresholds for accuracy, precision, linearity, etc.) or detailed reported performance data for the ST AIA-PACK AFP itself. Instead, it relies on the predicate device's established performance.
To construct a table, we would need the original 510(k) (P910006) which is not provided, but based on the text, the performance "acceptance criteria" are implicitly met if the performance is "equivalent" to the predicate.
| Acceptance Criteria Category | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Intended Use | Equivalent to predicate device (P910006) | "The intended use... of both assays are equivalent." |
| Assay Principles | Equivalent to predicate device (P910006) | "The... assay principles... of both assays are equivalent." |
| Antibody Type | Equivalent to predicate device (P910006) | "The... antibody type... of both assays are equivalent." |
| Analyte Detected | Equivalent to predicate device (P910006) | "The... analyte detected... of both assays are equivalent." |
| Performance Characteristics | Equivalent to predicate device (P910006) | "The... performance characteristics of both assays are equivalent." |
| Safety and Effectiveness | Not affected by modifications | "The proposed modifications... do not affect the safety and effectiveness of the device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on a specific "test set" and its sample size for the modified device. The submission relies on the concept of "substantial equivalence" to the predicate device P910006. The modifications are in "packaging, incubation period and certain components of the conjugate diluent." The implication is that these changes were not substantial enough to require a new, comprehensive clinical performance study to establish new performance criteria. Therefore, no specific sample size for a new test set is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to the provided document. The device is an in vitro diagnostic for quantitative measurement of AFP in serum, not one that requires expert interpretation of images or other subjective data for ground truth establishment. The ground truth for such devices is typically established through reference methods or highly characterized calibrators, not human expert consensus, especially for a 510(k) modification where performance is asserted to be equivalent to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., radiology reads) where discrepancies between readers need resolution. For an in vitro diagnostic, performance is usually measured quantitatively against a reference, not through multi-reader adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is an in vitro diagnostic for measuring AFP, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC study or assessment of AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone immunoassay kit used on a specific analyzer (TOSOH AIA System analyzers). It operates as an "algorithm only" in the sense that the instrument performs the assay and calculates results without human intervention in the result determination phase. However, the document does not detail specific "standalone performance studies" beyond stating equivalence to the predicate. The "performance characteristics of both assays are equivalent" implies that the standalone performance metrics (e.g., precision, accuracy, sensitivity, specificity, linearity, etc.) were demonstrated to be similar to the predicate device, but these specific studies or their results are not presented in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an in vitro diagnostic assay like this, the "ground truth" for validation studies (which led to the original P910006 clearance) would typically be established using:
- Reference materials/calibrators: Samples with known, accurately determined concentrations of AFP.
- Reference laboratory methods: Comparison with established, validated methods for AFP measurement.
- Clinical correlation: While not a direct "ground truth" for analytical performance, clinical utility is supported by correlation with disease status (e.g., in patients with nonseminomatous testicular carcinoma), often confirmed by pathology or clinical follow-up.
However, for this specific 510(k) modification, the document does not describe new ground truth establishment. It relies on the previously established ground truth for the predicate device, asserting that the modifications do not change the fundamental performance.
8. The sample size for the training set
This is not applicable. Immunoassays like the ST AIA-PACK AFP are not "trained" in the machine learning sense. Their performance is inherent in their biochemical design (antibodies, reagents, protocol). Therefore, there is no "training set" as understood in AI/ML contexts.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
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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 forUse | ST AIA-PACK AFP is designed for IN VITRODIAGNOSTIC USE ONLY for the quantitativemeasurement of Alpha-Fetoprotein (AFP) inserum to aid in the management of patients withnonseminomatous 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
§ 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.