(84 days)
Not Found
No
The device description details a standard immunoassay technology (LOCI®) for quantitative measurement of a biomarker. There is no mention of AI, ML, or any computational analysis beyond standard signal processing for quantification. The performance study focuses on analytical agreement between sample types, not on algorithmic performance.
No
Explanation: The device is described as an in vitro diagnostic test used for quantitative measurement of alpha-fetoprotein. Its intended use is to aid in managing cancer, not to treat or cure it.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The AFP method is an in vitro diagnostic test..."
No
The device description clearly outlines a hardware-based in vitro diagnostic test utilizing reagents, beads, and a chemiluminescent reaction measured by a system (Dimension Vista® System). This involves physical components and chemical processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states: "The AFP method is an in vitro diagnostic test for the quantitative measurement of alphafetoprotein in human serum and lithium heparinized plasma..." This directly identifies the device as an IVD.
- Device Description: The description details a laboratory test performed on biological samples (serum and plasma) using chemical reagents and a specific technology (LOCI®) to measure a substance (alpha-fetoprotein). This is characteristic of an in vitro diagnostic test.
- Performance Studies: The description of comparative studies on human serum and plasma samples further supports its use in a laboratory setting for diagnostic purposes.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AFP method is an in vitro diagnostic test for the quantitative measurement of alphafetoprotein in human serum and lithium heparin plasma on the Dimension Vista® System. Measurements of alpha-fetoprotein are used as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures.
Product codes
LOJ
Device Description
The Dimension Vista® AFP method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-AFP monoclonal antibody fragment. The first bead reagent (Chemibeads) is coated with an anti-AFP monoclonal antibody and contains chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-AFP-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 mm and is a direct function of the AFP concentration in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative data for equivalency studies on human serum versus lithium heparinized plasma samples demonstrates good analytical and clinical agreement between the sample types.
Study Type: Comparative Method
Sample Size: 70
Key Results: Slope = 0.99, Intercept = -0.05 ng/mL, Correlation Coefficient = 0.997
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
§ 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.
0
Siemens Healthcare Diagnostics Inc.
Modification to Dimension Vista® AFP Flex® reagent cartridge 510(k) Premarket Notification
APR 2 7 2009
510(k) Summary for Dimension Vista® AFP Flex® reagent cartridge
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K090236
A. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
| Manufacturer: | Siemens Healthcare Diagnostics Inc.
500 GBC Drive, M/S 514
P.O. Box 6101
Newark, Delaware 19714-6101 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Siemens Healthcare Diagnostics Inc.
500 GBC Drive, M/S 514
P.O. Box 6101
Attn: Janet M. Fose
Tel: 302-631-8826
Fax: 302-631-6299 |
January 30, 2009 Preparation date:
B. Name of Device:
Dimension Vista® AFP Flex® reagent cartridge
C. Regulatory Information:
CFR Section: 866.6010 - Tumor-Associated Antigen Immunological Test System Classification: Class II Classification Panel: Immunology (82) Product Code: LOJ
D. Predicate Device:
Dimension Vista® AFP Flex® reagent cartridge (K071597)
E. Device Description:
The Dimension Vista® AFP method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-AFP monoclonal antibody fragment. The first bead reagent (Chemibeads) is coated with an anti-AFP monoclonal antibody and contains chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form
1
Siemens Healthcare Diagnostics Inc. Modification to Dimension Vista AFP Flex® reagent cartridge 510(k) Premarket Notification
bead-AFP-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 mm and is a direct function of the AFP concentration in the sample.
F. Device Intended Use:
The AFP method is an in vitro diagnostic test for the quantitative measurement of alphafetoprotein in human serum and lithium heparin plasma on the Dimension Vista® System. Measurements of alpha-fetoprotein are used as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures.
G. Substantial equivalence information:
The Siemens Dimension Vista® AFP method modification to add lithium heparinized plasma as a sample type and the predicate Dimension Vista® AFP method are both in vitro diagnostic immunoassays intended for the measurement of alpha-fetoprotein (AFP) as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures.
| Similarities | ||
|---|---|---|
| Feature | Device | Predicate |
| Intended Use | The AFP method is an in vitro | |
| diagnostic test for the quantitative | ||
| measurement of alpha-fetoprotein in | ||
| human serum and lithium heparin | ||
| plasma on the Dimension Vista® | ||
| System. Measurements of alpha- | ||
| fetoprotein are used as an aid in | ||
| managing non-seminomatous | ||
| testicular cancer when used in | ||
| conjunction with physical | ||
| examination, histology/pathology, | ||
| and other clinical evaluation | ||
| procedures. | The AFP method is an in vitro | |
| diagnostic test for the quantitative | ||
| measurement of alpha-fetoprotein | ||
| in human serum on the Dimension | ||
| Vista® System. Measurements of | ||
| alpha-fetoprotein are used as an aid | ||
| in managing non-seminomatous | ||
| testicular cancer when used in | ||
| conjunction with physical | ||
| examination, histology/pathology, | ||
| and other clinical evaluation | ||
| procedures | ||
| Standardization | Traceable to the World Health | |
| Organization (WHO) Reference | ||
| preparation for human AFP | ||
| (72/225) | Traceable to the World Health | |
| Organization (WHO) Reference | ||
| preparation for human AFP | ||
| (72/225) | ||
| Measurement method | Chemiluminescent: | |
| Homogenous sandwich | ||
| immunoassay based on LOCI® | ||
| technology | Chemiluminescent: | |
| Homogenous sandwich | ||
| immunoassay based on LOCI® | ||
| technology | ||
| Measuring Range | $0.5- 1000.0$ ng/mL | $0.5- 1000.0$ ng/mL |
| Sample | 2 uL | 2 uL |
A comparison summary of the features of the products is included in the following table:
2
Siemens Healthcare Diagnostics Inc.
Modification to Dimension Vista® AFP Flex® reagent cartridge 510(k) Premarket Notification
| Differences | ||
|---|---|---|
| Feature | Device | Predicate |
| Intended Use | The AFP method is an in vitro | |
| diagnostic test for the quantitative | ||
| measurement of alpha-fetoprotein in | ||
| human serum and lithium heparin | ||
| plasma on the Dimension Vista® | ||
| System. Measurements of alpha- | ||
| fetoprotein are used as an aid in | ||
| managing non-seminomatous | ||
| testicular cancer when used in | ||
| conjunction with physical | ||
| examination, histology/pathology. | ||
| and other clinical evaluation | ||
| procedures | The AFP method is an in vitro | |
| diagnostic test for the | ||
| quantitative measurement of | ||
| alpha-fetoprotein in human | ||
| serum on the Dimension Vista® | ||
| System. Measurements of alpha- | ||
| fetoprotein are used as an aid in | ||
| managing non-seminomatous | ||
| testicular cancer when used in | ||
| conjunction with physical | ||
| examination, | ||
| histology/pathology, and other | ||
| clinical evaluation procedures | ||
| Sample Types | Serum and plasma (lithium heparin) | Serum |
H. Comments about Substantial Equivalence:
The same scientific technology and manufacturing processes are used for both devices. No formulation or design changes were made for the method modification. Comparative data for equivalency studies on human serum versus lithium heparinized plasma samples demonstrates good analytical and clinical agreement between the sample types. Summary results for the matched pairs study are described below:
| Comparative Method | Slope | Intercept
ng/mL | Correlation
Coefficient | n |
|----------------------|-------|--------------------|----------------------------|----|
| Dimension Vista® AFP | 0.99 | -0.05 | 0.997 | 70 |
I. Conclusion:
The Siemens Dimension Vista® AFP method modification to add lithium heparinized plasma as a sample type and the predicate Dimension Vista® AFP method (K071597) are substantially equivalent based on their intended use, device features and performance characteristics as described above.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics Inc. c/o Ms Janet M. Fose Regulatory Affairs Specialist 500 GBC Drive, M/S 514 P.O. Box 6101 Newark, DE 19714-6101
APR 9 7 2009
Re: K090236
Trade/Device Name: Dimension Vista® AFP Flex® reagent cartridge Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: II Product Code: LOJ Dated: January 30, 2009 Received: February 2, 2009
Dear Ms. Fose:
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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the
4
Page 2 – Ms Janet M. Fose
quality systems (QS) regulation (21 CFR Part 820). 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 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" (21 CFR 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. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Mana M Clan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Dimension Vista® AFP Flex® reagent cartridge
Indication for Use:
The AFP method is an in vitro diagnostic test for the quantitative measurement of alphafetoprotein in human serum and lithium heparinized plasma on the Dimension Vista® System. Measurements of alpha-fetoprotein are used as an aid in managing nonseminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures.
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)
ia M Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090236