(487 days)
TOSOH Medical, Inc. ST AIA Pack BRCA
Not Found
No
The description details a standard automated immunoassay technique (ELFA) with results calculated based on a stored calibration curve. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or result calculation.
No
The device is an in vitro diagnostic test used for the quantitative measurement of CA 15-3 levels, aiding in the monitoring of breast cancer and detection of recurrence. It does not provide therapy or treatment to the patient.
Yes
This device is a diagnostic device because it is indicated for the quantitative measurement of CA 15-3 reactive antigenic determinants in human serum as an aid in monitoring patients previously diagnosed with breast cancer for disease progression or response to therapy, and as an aid in the detection of recurrence in previously treated breast cancer patients. This involves generating information used for clinical diagnosis and management.
No
The device description clearly outlines physical components like the Solid Phase Receptacle (SPR) and reagent strips (STRs), and describes a chemical assay process (ELFA) performed by an automated instrument. This indicates 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: The intended use explicitly states it is for the "quantitative measurement of CA 15-3 reactive antigenic determinants in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a patient's health status (monitoring breast cancer).
- Device Description: The description details an "automated quantitative test" that uses an "ELFA technique" to measure CA 15-3 levels in "human serum." This further confirms it's a test performed on a biological sample outside the body.
- Assay Principle: The description of the assay principle clearly outlines a laboratory-based process involving reagents, antibodies, and detection of a signal in a sample, all characteristic of an in vitro diagnostic test.
The core function of the device is to analyze a biological sample (serum) outside the body to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VIDAS® CA 15-3 is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of CA 15-3 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 15-3 is indicated for the serial measurement of CA 15-3 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with breast cancer for disease progression or response to therapy in conjunction with other clinical methods. The VIDAS CA 15-3 assay can also be used as an aid in the detection of recurrence in previously treated Stage II and III breast cancer patients.
Product codes (comma separated list FDA assigned to the subject device)
LTK
Device Description
VIDAS CA 15-3 is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of CA 15-3 levels in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 15-3 assay is indicated for the serial measurement of CA 15-3 as an aid in the monitoring of disease progression or response to therapy in patients previously diagnosed with breast cancer.
The assay principle combines a two-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. It is coated with mouse monoclonal 115D8 antibodies. The other assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). The individual kit components are described in detail on the following pages.
All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. This operation enables the monoclonal 115D8 antibody fixed onto the interior wall of the SPR to capture the reactive antigenic determinants present in the sample. Unbound components are eliminated during the washing steps. Alkaline phosphatase labeled monoclonal DF3 antibody (conjugate) is then incubated in the SPR where it binds with the CA 15-3 reactive antigenic determinant. Unbound conjugate is then eliminated during the washing steps.
During the final detection step, the substrate (4-Methyl-umbellifery| phosphate) is cycled in and out of the SPR. The conjuqate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methy)-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of CA 15-3 reactive antigenic determinants present in the sample.
At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.
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)
Non-clinical (Analytical) Comparison
- Intra-Assay Precision:
- n = 40 replicates, 2 lots, 3 sites
- Pool A: Mean = 270.0 U/mL, CV = 2.1 - 4.0%
- Pool B: Mean = 67.7 U/mL, CV = 3.2 - 4.5%
- Pool C: Mean = 21.4 U/mL, CV = 2.3 - 4.1%
- Inter-Run Precision:
- n = 20 runs
- Pool A: Mean = 270.0 U/mL, CV = 0.0 - 1.2%
- Pool B: Mean = 67.7 U/mL, CV = 0.0 - 1.4%
- Pool C: Mean = 21.4 U/mL, CV = 0.6-2.2%
- Limits of Detection: 0.724 U/mL (
§ 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® CA 15-3 Assay
A. Submitter Information
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Sandra Perreand |
| Phone Number: | 314-731-8594 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | April 17, 2009 |
| JUN 22 2009 |
B. Device Name
Trade Name:
VIDAS® CA 15-3 Assay
Common Name: CA 15-3
Classification Name: System. Test, CA 15-3, for monitoring and management of breast cancer
C. Predicate Device Name
Trade Name:
TOSOH Medical, Inc. ST AIA Pack BRCA
D. Device Description
VIDAS CA 15-3 is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of CA 15-3 levels in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 15-3 assay is indicated for the serial measurement of CA 15-3 as an aid in the monitoring of disease progression or response to therapy in patients previously diagnosed with breast cancer.
CA 15-3 is a registered trademark from Fujirebio Diagnostics Inc. (formerly named Centocor Diagnostics of Pennsylvania, Inc.)
The assay principle combines a two-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. It is coated with mouse monoclonal 115D8 antibodies. The other assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). The individual kit components are described in detail on the following pages.
All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. This operation enables the monoclonal 115D8 antibody fixed onto the interior wall of the SPR to capture the reactive antigenic determinants present in the sample. Unbound components are eliminated during the washing steps. Alkaline phosphatase labeled monoclonal DF3 antibody
1
(conjugate) is then incubated in the SPR where it binds with the CA 15-3 reactive antigenic determinant. Unbound conjugate is then eliminated during the washing steps.
During the final detection step, the substrate (4-Methyl-umbellifery| phosphate) is cycled in and out of the SPR. The conjuqate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methy)-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of CA 15-3 reactive antigenic determinants present in the sample.
At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.
E. Intended Use
VIDAS® CA 15-3 is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of CA 15-3 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 15-3 is indicated for the serial measurement of CA 15-3 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with breast cancer for disease progression or response to therapy in conjunction with other clinical methods. The VIDAS CA 15-3 assay can also be used as an aid in the detection of recurrence in previously treated Stage II and III breast cancer patients.
F. Technological Characteristics Summary
A general comparison of the similarities and differences of the VIDAS CA 15-3 assay to the predicate device is presented in the table below.
| Item | VIDAS® CA 15-3 Assay | TOSOH ST AIA-PACK
BRCA (K010796) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Comparison | | |
| Intended Use | VIDAS® CA 15-3 is an automated
quantitative test for use on the VIDAS
instruments for the quantitative
measurement of CA 15-3 reactive
antigenic determinants in human serum
using the ELFA technique (Enzyme
Linked Fluorescent Assay). The VIDAS
CA 15-3 is indicated for the serial
measurement of CA 15-3 reactive
antigenic determinants as an aid in the
monitoring of patients previously
diagnosed with breast cancer for disease
progression or response to therapy in
conjunction with other clinical methods.
The VIDAS CA 15-3 assay can also be
used as an aid in the detection of
recurrence in previously treated Stage II
and III breast cancer patients. | ST AIA-PACK BRCA is designed for IN
VITRO DIAGNOSTIC USE ONLY for
the quantitative measurement of
CA27.29 in human serum on TOSOH
AIA Nex IA and AIA-600 II
Immunoassay analyzers. ST AIA-PACK
BRCA is to be used as an aid in
monitoring response to therapy for
patients with Stage IV (metastatic)
breast cancer as well as determining
early recurrence in Stage II and Stage III
breast cancer patients who were
previously treated and free of disease.
Serial testing for patient CA27.29 assay
values should be used in conjunction
with other clinical methods used for
monitoring response to therapy in
patients with Stage IV metastatic breast
cancer and for detecting early
recurrence in Stage II and Stage III
disease. |
| Specimen | Serum | Serum |
| Analyte | CA 15-3 | CA 27.29 (CA15-3) |
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| Item | VIDAS® CA 15-3 Assay | TOSOH ST AIA-PACK
BRCA (K010796) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Comparison | | |
| Antibody | mouse monoclonal 115D8 and DF3
antibodies | mouse monoclonal antibodies to CA 15-
3 |
| Assay Principle | Two antibody "sandwich" binding of CA
15-3 antigen. 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 CA
27.29. 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 | 20 μL |
| Traceability/
Standardization | Master curve for each kit lot and each
calibrator lot are traceable to working
standards established by bioMérieux, Inc.
and value assigned by the Fujirebio
Diagnostics, Inc. radioimmunoassay
method | Each calibrator lot are traceable to
internal reference standards |
| Measurement range | 2.00 - 365 U/mL | 2.0 - 400 U/mL |
G. Performance Data
.
:
A summary of the non-clinical and clinical test results is presented in the table below.
| Test | VIDAS® CA 15-3 Assay | TOSOH ST AIA-PACK
BRCA (K010796) |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Non-clinical (Analytical) Comparison | | |
| | n = 40 replicates, 2 lots, 3 sites
Pool A: Mean = 270.0 U/mL
CV = 2.1 - 4.0% | n = 10 replicates
Control L: Mean = 41.3 U/mL
CV = 2.2% |
| Intra-Assay Precision | Pool B: Mean = 67.7 U/mL
CV = 3.2 - 4.5%
Pool C: Mean = 21.4 U/mL
CV = 2.3 - 4.1% | Control H: Mean = 300.9 U/mL
CV = 1.4% |
| Inter-Run Precision | n = 20 runs
Pool A: Mean = 270.0 U/mL
CV = 0.0 - 1.2%
Pool B: Mean = 67.7 U/mL
CV = 0.0 - 1.4%
Pool C: Mean = 21.4 U/mL
CV = 0.6-2.2% | n = 21 runs
Control L: Mean = 40.4 U/mL
CV = 2.2%
Control H: Mean = 301.0 U/mL
CV = 2.2% |
| Limits of Detection | 0.724 U/mL ( 50 years (95% percentile) =
29.62 – 36.95 U/mL
All females (95% percentile) = 26.99 –
32.07 U/mL | Females, pre-menopausal (99%
order statistic) = 28.6 – 44.3 U/mL
Females, post-menopausal (99%
order statistic) = 38.9 – 43.4 U/mL
All females (99% order statistic) =
34.8 – 44.3 U/mL
Male (99% order statistic) = 36.0 –
84.8 U/mL |
| Method Comparison | | |
| Methods | X = TOSOH ST AIA-Pack BRCA; y = VIDAS® CA 15-3 | |
| Number of patients | 1,035 samples | |
| Results | Slope = 0.96 (95% confidence interval = 0.83 to 1.09)
Intercept = -1.94 (95% confidence interval = -4.90 to +1.01) | |
H. Conclusion
The VIDAS® CA 15-3 Assay is substantially equivalent to the Tosoh Medical, Inc. TOSOH ST AIA-PACK BRCA
The 510(k) summary includes only information that is also covered in the 510(k). The summary does not contain any puffery or unsubstantiated labeling claims. The summary does not contain any raw data, i.e., contains only summary data. The summary does not contain any trade secret or confidential commercial information. The summary does not contain any patient identification information.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle, indicating the department's name and national affiliation. The logo is simple, using a monochromatic color scheme.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 22 2009
BioMérieux, Inc. c/o Ms. Sandra L. Perreand Senior Director, North American Regulatory Affairs 595 Anglum Rd Hazelwood, MO 63042
Re: K080469
Trade/Device Name: VIDAS® CA 15-3 Regulation Number: 21 CFR 866.6010 Regulation Name: Turnor-associated antigen immunological test system Regulatory Class: Class II Product Code: LTK Dated: February 26, 2009 Received: February 27, 2009
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 will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding
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Page 2 – Ms. Sandra L. Perreand
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.hhml.
Sincerely yours,
Maria M. Chan
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
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Indications for Use
510(k) Number (if known): K080469
Device Name: VIDAS® CA 15-3
Indication for Use:
VIDAS® CA 15-3 is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of CA 15-3 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 15-3 is indicated for the serial measurement of CA 15-3 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with breast cancer for disease progression or response to therapy in conjunction with other clinical methods. The VIDAS CA 15-3 assay can also be used as an aid in the detection of recurrence in previously treated Stage II and III breast cancer patients.
Prescription Use × (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Van Bui
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080469