(267 days)
TOSOH ST AIA-PACK AFP (K023894)
Not Found
No
The device description details a standard immunoassay technique (ELFA) with automated steps and calculation based on stored calibration curves. There is no mention of AI, ML, or any learning algorithms.
No
The device is an automated quantitative test used to measure alpha-fetoprotein (AFP) in human serum to aid in the management of patients, making it a diagnostic tool, not a therapeutic one.
Yes
The device quantitatively measures alpha-fetoprotein (AFP) in human serum to aid in the management of patients with a specific type of cancer, which indicates its use in diagnosing or monitoring a medical condition.
No
The device description clearly outlines physical components like the Solid Phase Receptacle (SPR) and reagent strips (STRs), and describes a process involving physical manipulation of samples and reagents within a VIDAS instrument. This indicates a hardware component is integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for the "quantitative measurement of alpha-fetoprotein (AFP) in human serum." This indicates it is used to test a sample taken from the human body in vitro (outside the body).
- Device Description: The description details a laboratory assay using reagents and a specific instrument to analyze a biological sample (serum). This is characteristic of an IVD.
- ELFA Technique: The use of the ELFA technique, which involves chemical reactions and fluorescent detection on a biological sample, is a common method in IVD testing.
- Clinical Trial: The description of a clinical trial comparing the device to another assay for testing patient samples further supports its classification as an IVD.
- Predicate Device: The mention of a predicate device (K023894; TOSOH ST AIA-PACK AFP) which is also an IVD, indicates that this device is intended for a similar diagnostic purpose.
All of these factors point to the VIDAS® AFP being a device used to perform diagnostic tests on samples taken from the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VIDAS® AFP is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of alpha-fetoprotein (AFP) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS AFP assay is indicated for the quantitative measurement of Alpha-Fetoprotein (AFP) in serum to aid in the management of patients with nonseminomatous testicular carcinoma.
Product codes (comma separated list FDA assigned to the subject device)
LOJ
Device Description
The assay principle combines a one-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. The assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs).
All of the assay steps are performed automatically by the VIDAS instrument. The sample is transferred into the well containing AFP antibody (conjugate) labeled with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and to the conjugate to form a sandwich. Unbound compounds are eliminated during washing steps.
Two detection steps are performed successively. During each step, the substrate (4-Methylumbeliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample.
At the end of the assay, results are automatically calculated by the VIDAS instrument in relation to two calibration curves corresponding to the two detection steps stored in memory, and then printed out.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
A clinical trial was conducted to compare the VIDAS® AFP and the TOSOH ST AIA-PACK AFP assays by testing 257 samples with both assays. A Passing and Bablok regression analysis of the 253 samples gave a slope = 1.128 (95% confidence interval = 1.115 to 1.143) and an intercept = - 0.530 (95% confidence interval = -0.658 to -0.416).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision: A panel of three samples was assayed in duplicate in 40 different runs (2 runs per day) with two reagent lots using the same VIDAS instrument at three sites. The total variability (%CV) across all sites and across all samples was 400 IU/mL) up to 1/20 prior to retesting. Two high titer natural sera and one low titer natural serum are mixed in variable proportions to yield dilutions that cover the assay's full measurement range and the medical decision level (10 IU/mL). The linearity of the assay is 0.500 - 400.00 IU/mL.
Clinical Trial: A clinical trial was conducted to compare the VIDAS® AFP and the TOSOH ST AIA-PACK AFP assays by testing 257 samples with both assays. A Passing and Bablok regression analysis of the 253 samples gave a slope = 1.128 (95% confidence interval = 1.115 to 1.143) and an intercept = - 0.530 (95% confidence interval = -0.658 to -0.416).
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.
TOSOH ST AIA-PACK AFP (K023894)
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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510(k) SUMMARY
VIDAS® AFP Assay
A. Submitter Information
bioMérieux, Inc. Submitter's Name: 595 Anglum Road Address: Hazelwood, MO 63042 Sandra Perreand Contact Person: 314-731-8594 Phone Number: 314-731-8689 Fax Number: Date of Preparation: September 18, 2008 B. Device Name VIDAS® AFP Assay Trade Name: Kit, Test, Alpha-Fetoprotein for Testicular Cancer Common Name: Kit, Test, Alpha-Fetoprotein for Testicular Cancer Classification Name:
C. Predicate Device Name
Tosoh Medical, Inc. ST AIA Pack AFP Enzyme Immunoassay
D. Device Description
Trade Name:
The assay principle combines a one-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. The assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs).
All of the assay steps are performed automatically by the VIDAS instrument. The sample is transferred into the well containing AFP antibody (conjugate) labeled with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and to the conjugate to form a sandwich. Unbound compounds are eliminated during washing steps.
Two detection steps are performed successively. During each step, the substrate (4-Methylumbeliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample.
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At the end of the assay, results are automatically calculated by the VIDAS instrument in relation to two calibration curves corresponding to the two detection steps stored in memory, and then printed out.
E. Intended Use
VIDAS® AFP is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of alpha-fetoprotein (AFP) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS AFP assay is indicated for the quantitative measurement of Alpha-Fetoprotein (AFP) in serum to aid in the management of patients with nonseminomatous testicular.
F. Technological Characteristics Summary
A general comparison of the similarities and differences of the VIDAS AFP assay to the predicate device is presented in the table below.
| Item | VIDAS® AFP Assay | TOSOH ST AIA-PACK AFP
(K023894) |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | VIDAS® AFP is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of alpha-fetoprotein (AFP) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS AFP assay is indicated for the quantitative measurement of Alpha-Fetoprotein (AFP) in serum to aid in the management of patients with nonseminomatous testicular carcinoma. | 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. |
| Specimen | Serum | Serum |
| Antibody | Two mouse monoclonal AFP antibodies | Two mouse monoclonal AFP antibodies |
| Assay Principle | Two antibody "sandwich" binding of AFP. One antibody is bound to a solid phase and the second antibody is in liquid form and is labeled with fluorescent compound | Two antibody "sandwich" binding of AFP. One antibody is bound to a solid phase and the second antibody is in liquid form and is labeled with fluorescent compound |
| Automated | Yes | Yes |
| Assay Technique | Enzyme-linked fluorescent assay (ELFA) | Two-site immunoenzymometric assay |
| Sample Volume | 100 µL | 25 µL |
| Traceability/ | Master curve for each kit lot and each | Each calibrator lot are traceable |
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| Item | VIDAS® AFP Assay | TOSOH ST AIA-PACK AFP
(K023894) |
|-------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Standardization | calibrator lot are traceable to 1st IS 72/225 International Reference Preparation (IRP) | to 1st IS 72/225 International Reference Preparation (IRP) |
| Measurement range | 0.500 – 400.00 IU/mL
Master curve highest calibration point = 400.0 IU/mL | 1 – 400 ng/mL
(0.83 – 330.6 IU/mL)
Highest calibrator = 200 ng/mL
(165.3 IU/mL) |
G. Performance Data
A summary of the non-clinical and clinical test results is presented below.
Precision
A panel of three samples was assayed in duplicate in 40 different runs (2 runs per day) with two reagent lots using the same VIDAS instrument at three sites. The total variability (%CV) across all sites and across all samples was 400 IU/mL) up to 1/20 prior to retesting.
Two high titer natural sera and one low titer natural serum are mixed in variable proportions to yield dilutions that cover the assay's full measurement range and the medical decision level (10 IU/mL). The linearity of the assay is 0.500 - 400.00 IU/mL.
Clinical Trial
A clinical trial was conducted to compare the VIDAS® AFP and the TOSOH ST AIA-PACK AFP assays by testing 257 samples with both assays. A Passing and Bablok regression analysis of the 253 samples gave a slope = 1.128 (95% confidence interval = 1.115 to 1.143) and an intercept = - 0.530 (95% confidence interval = -0.658 to -0.416).
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H. Conclusion
:
The VIDAS® AFP Assay is substantially equivalent to the Tosoh Medical, Inc. ST AIA Pack AFP Assay.
:
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle with its wings spread, symbolizing protection and strength. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 6 2008
bioMèricux, Inc. c/o Ms. Sandra Perreand Senior Director, North American Regulatory Affairs 595 Anglum Road Hazelwood, MO 63042
Re: K080017
Trade/Device Name: Vidas® AFP Assay Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor associated antigen immunological test systems Regulatory Class: Class II Product Code: LOJ Dated: August 28, 2008 Received: September 2, 2008
Dear Ms. Perreand:
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). This letter
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Page 2 - bioMèrieux, Inc.
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ia Mc Chan
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K080017
Device Name: VIDAS® AFP
Indications For Use:
VIDAS® AFP is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of alpha-fetoprotein (AFP) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS AFP assay is indicated for the quantitative measurement of Alpha-Fetoprotein (AFP) in serum to aid in the management of patients with nonseminomatous testicular carcinoma.
Prescription Use _ X ____________________________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use_ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Qeena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) - K080017