(358 days)
P820060/S019, K981354
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No
The device description details a standard immunoassay based on chemiluminescent technology, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic test for measuring alpha-fetoprotein, which is used as an aid in managing testicular cancer, not for treating or curing a disease.
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 physical components (reagents, beads, calibrator vials) and a chemical reaction process, indicating it is a hardware-based in vitro diagnostic device, not software-only.
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 alpha-fetoprotein in human serum..." This directly identifies it as an IVD.
- Measurement in Human Samples: The test measures alpha-fetoprotein in "human serum," which is a biological sample taken from the human body. This is a key characteristic of IVDs.
- Aid in Medical Management: The results are used as an "aid in managing non-seminomatous testicular cancer," indicating that the test provides information used for medical purposes.
- Device Description: The description details a laboratory method (homogeneous, sandwich chemiluminescent immunoassay) and reagents used to analyze the sample outside of the body.
- Calibrator: The inclusion of a calibrator is typical for quantitative IVD tests to ensure accurate measurements.
All of these points align 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 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.
For the calibration of the Alpha-Fetoprotein (AFP) method on the Dimension Vista® System.
Product codes (comma separated list FDA assigned to the subject device)
LOJ, JIX
Device Description
Method
The AFP method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCT™ 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 dve. 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 nm and is a direct function of the AFP concentration in the sample.
Calibrator
The LOCI 5 Calibrator is a liquid multi-analyte product containing AFP from human cord serum. An additional analyte (CEA from human tissue culture) is contained in the product and will be included in the submission to FDA with its respective method. The kit consists of ten vials, two each of five levels containing 2 mL per vial. Description of the manufacturing, value assignment and stability testing processes are provided.
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)
A split sample method comparison demonstrated good agreement between the Dade Behring Dimension Vista® AFP method and the predicate Abbott AxSYM® AFP method following CLSI Approved Guideline for Method Comparison and Bias Estimation Using Patient Samples; EP9-A2.
The method used to fit the lincar regression line was Passing-Bablok. The range of 317 values in the correlation study was 0.97 - 881.24 ng/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Slope: 0.93
Intercept ng/mL: 0.1
Correlation Coefficient: 0.995
n: 317
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.
P820060/S019, K981354
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
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K071597
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
| Manufacturer: | Siemens Healthcare Diagnostics Inc.
P.O. Box 6101
Newark, DE 19714 |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Siemens Healthcare Diagnostics Inc.
P.O. Box 6101
Newark, DE 19714
Attn: Pamela A. Jurga
Tel: 302-631-8891 |
| Date of Preparation: | May 8, 2008 |
2. Device Name / Classification
- Dimension Vista® AFP reagent cartridge/ Class II .
- . Dimension Vista® LOCI 5 calibrator/ Class II
3. Identification of the Predicate Device
- Abbott AxSYM® AFP Method (P820060/S019) .
- . Beckman Access AFP Calibrators on the Access® Immunoassay System (K981354).
FDA Guidance Document(s):
- "Bundling Multiple Devices or Multiple Indications in a Single Submission"-. 11/26/2003
- . "Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable -Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff "- 4/25/2006
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4. Device Description(s):
Method
The AFP method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCT™ 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 dve. 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 nm and is a direct function of the AFP concentration in the sample.
Calibrator
The LOCI 5 Calibrator is a liquid multi-analyte product containing AFP from human cord serum. An additional analyte (CEA from human tissue culture) is contained in the product and will be included in the submission to FDA with its respective method. The kit consists of ten vials, two each of five levels containing 2 mL per vial. Description of the manufacturing, value assignment and stability testing processes are provided.
5. Device Intended Use:
Method
The AFP method is an in vitro diagnostic test for the quantitative measurement of alpha-fetoprotein in human 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.
Calibrator
For the calibration of Alpha-Fetoprotein (AFP) method on the Dimension Vista® System.
6. Medical device to which equivalence is claimed:
Substantial Equivalence:
These products are substantially equivalent to other AFP test systems, such as the Abbott AxSYM® AFP Method (P820060/S019) and calibrators; Beckman Access AFP Calibrators on the Access® Immunoassay System (K981354).
Comparison to Predicate Device:
The proposed Dade Behring Dimension Vista® AFP method and the predicate Abbott AxSYM® AFP method are both in vitro diagnostic immunoassays intended for the measurement of alphafetoprotein (AFP) as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures.
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The Dade Behring Dimension Vista® LOCI 5 calibrator and the predicate Beckman Access AFP Calibrators are both calibrators intended to calibrate their associated AFP methods.
A comparison summary of the features of the products is included in the following table.
Method:
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use | 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. | AxSYM AFP is a Microparticle | |
| Enzyme Immunoassay (MEIA) | ||
| for the quantitative | ||
| determination of alpha- | ||
| fetoprotein (AFP) in: |
- Human serum or plasma to
aid in the management of
patients with non-
seminomatous testicular
cancer. |
| 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 LOCITM
technology | Microparticle Enzyme
Immunoassay (MEIA)
technology |
| Differences | | |
| Item | Device | Predicate |
| Intended Use | Same as above | for the quantitative
determination of alpha-
fetoprotein (AFP) in:
Human serum, plasma and
amniotic fluid at 15 to 21
weeks gestation to aid in the
detection of fetal open neural
tube defects (NTD). Test
results when used in
conjunction with
ultrasonography or |
| | | amniography are a safe and
effective aid in the detection of
fetal open NTD. |
| Measuring Range | 0.5-1000.0 ng/mL | 0.4-350.0 ng/mL |
| Sample Types | Serum | Serum, plasma
Amniotic fluid |
| Sample Size | 2 uL | 58 uL |
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Calibrator:
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use | For the calibration of Alpha- | |
| Fetoprotein (AFP) method on the | ||
| Dimension Vista® system. | The Access AFP Calibrators are | |
| intended to calibrate the Access | ||
| AFP assay for the quantitative | ||
| determination of AFP levels in | ||
| human serum, using the Access | ||
| Immunoassay System. | ||
| Traceability | AFP- World Health | |
| Organization (WHO) Reference | ||
| Preparation 72/225 | AFP- World Health | |
| Organization (WHO) Reference | ||
| Preparation 72/225 | ||
| Matrix | BSA-based matrix | BSA-based matrix |
| Preparation | Liquid: | |
| Provided ready to use. | Liquid: | |
| Provided ready to use. | ||
| Differences | ||
| Item | Device | Predicate |
| Target | ||
| Concentrations | ||
| AFP | Level 1 (CAL A): 0 ng/mL | |
| Level 2 (CAL B): 8 ng/mL | ||
| Level 3 (CAL C): 100 ng/mL | ||
| Level 4 (CAL D): 500 ng/mL | ||
| Level 5 (CAL E): 1050 ng/mL | Level 1 : 0 ng/mL | |
| Level 2: 2.5 ng/mL | ||
| Level 3 5 ng/mL | ||
| Level 4 25 ng/mL | ||
| Level 5: 100 ng/mL | ||
| Level 6: 500 ng/mL | ||
| Level 7: 3000 ng/mL | ||
| Storage | Store at 2 to 8°C. | Store at 2 to 10°C. |
Comments on Substantial Equivalence:
Method
The Dade Behring Dimension Vista® AFP method and the predicate Abbott AxSYM® AFP method are both in vitro diagnostic immunoassays intended for the measurement of alpha-fetoprotein (AFP)
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as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures.
Comparative data for human serum samples demonstrate good analytical and clinical agreement between the methods including the split sample method comparison described below:
A split sample method comparison demonstrated good agreement between the Dade Behring Dimension Vista® AFP method and the predicate Abbott AxSYM® AFP method following CLSI Approved Guideline for Method Comparison and Bias Estimation Using Patient Samples; EP9-A2.
| Comparative Method | Slope | Intercept
ng/mL | Correlation
Coefficient | n |
|--------------------|-------|--------------------|----------------------------|-----|
| AxSYM® AFP | 0.93 | 0.1 | 0.995 | 317 |
AxSYM® is a registered trademark of Abbott Laboratories, Abbott Park, III 60064 USA
The method used to fit the lincar regression line was Passing-Bablok. The range of 317 values in the correlation study was 0.97 - 881.24 ng/mL.
Calibrator
The Dade Bchring Dimension Vista® LOCI 5 calibrator and the predicate Beckman Access AFP Calibrators are both calibrators intended to calibrate their associated AFP methods.
Conclusion:
The Dade Behring Dimension Vista® AFP method and the predicate Abbott AxSYM® AFP method (P820060/S019) are substantially equivalent based on their intended use and performance characteristics as described above. The calibrator products, the Dade Behring Dimension Vista® LOCI 5 calibrator and the predicate Beckman Access AFP calibrators are also substantially equivalent in its design and intended use with their respective assay systems (K981354).
Pamela A. Ivez
Pamela A area Regulatory Affairs and Compliance Manager May 8, 2008
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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three parallel lines instead of a single staff.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics Inc. c/o Ms. Pamela A Jurga Regulatory Affairs and Compliance Manager P.O. Box 6101, M/S 514 Newark, DE 19714-6101
Re: K071597
Trade/Device Name: Dimension Vista® AFP reagent cartridge Dimension Vista® LOCI 5 calibrator Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: LOJ, JIX Dated: May 28, 2008 Received: May 29, 2008
Dear Ms. Jurga:
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.
JUN - 4 2008
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the 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
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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 (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. 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,
Robert Becker
Robert L. Becker, Jr., M.D., 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
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Indications for Use
510(k) Number (if known): K071597
Indications For Use:
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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)
Page 1 of 1
Mana M. Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071597
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Dade Behring Inc. Dimension Vista® AFP Method and LOCI 5 Calibrator Updated 510(k) Premarket Notification - K071597
Indications for Use
Device Name:
Dimension Vista® LOCI 5 Calibrator
Indications for Use:
For the calibration of the Alpha-Fetoprotein (AFP) method on the Dimension Vista® System.
Prescription Use J (Per 21 CFR 801 Subpart D)
r w m m m m w m m w w w w w w w w m w m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m m
AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)
Page 1 of 1
Mana M. Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
10/1) Ko 71597