(407 days)
Not Found
No
The description details a standard automated immunoassay technique (ELFA) and mentions results being calculated based on a stored calibration curve, which is a typical function of automated lab instruments and does not indicate AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is an automated quantitative test used to measure specific antigenic determinants as an aid in monitoring ovarian cancer, not to treat it.
Yes
The device "VIDAS CA 125 II" is described as an "automated quantitative test" intended for "measurement of OC 125 reactive antigenic determinants in human serum" and is "indicated for the serial measurement... as an aid in the monitoring of patients previously diagnosed with ovarian cancer for disease progression or response to therapy" and "as an aid in the detection of recurrence". These uses directly support medical diagnosis and monitoring.
No
The device description explicitly details physical components like Solid Phase Receptacles (SPRs) and reagent strips (STRs), and describes an automated process involving these physical elements and an instrument. This indicates it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "measurement of OC 125 reactive antigenic determinants in human serum" and is used "as an aid in the monitoring of patients previously diagnosed with ovarian cancer for disease progression or response to therapy" and "as an aid in the detection of recurrence in previously treated ovarian cancer patients." This clearly indicates it's used to test human samples (serum) to provide information about a medical condition (ovarian cancer).
- Device Description: The description details a laboratory-based assay (ELFA technique) performed on a specific instrument (VIDAS instruments) using reagents (SPR, reagent strips) to analyze a biological sample (human serum). This is characteristic of an in vitro diagnostic device.
- Performance Studies: The document includes performance data like precision and comparison with other test methods, which are standard for demonstrating the analytical performance of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K023891; TOSOH Medical, Inc. ST AIA Pack CA 125 Enzyme lmmunoassay) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VIDAS® CA 125 II is an automated quantitative test for use on the VIDAS instruments, for the measurement of OC 125 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 125 II is indicated for the serial measurement of OC 125 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with ovarian cancer for disease progression or response to therapy. The VIDAS CA 125 Il assay can also be used as an aid in the detection of recurrence in previously treated ovarian cancer patients.
Product codes
LTK
Device Description
VIDAS® CA 125 II is an automated quantitative test for use on the VIDAS instruments, for the measurement of CA 125 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 125 II is indicated for the serial measurement of OC 125 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with Stage IV (metastatic) ovarian cancer for disease progression or response to therapy. The VIDAS CA 125 II assay can also be used as an aid in the early detection of recurrence in previously treated Stage II and III ovarian cancer patients.
CA 125 II 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 M 11 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 M11 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 mouse monoclonal OC 125 antibody (conjugate) is then incubated in the SPR where it binds with the OC 125 reactive antigenic determinant. Unbound conjugate is then eliminated during the washing steps.
During the final detection step, the substrate (4-Methyl-umbelliferyl 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 OC 125 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)
Precision:
Three serum samples were tested in duplicate in 40 different runs (2 runs per day over 20 sequential days) with 2 reagent lots using one instrument at each of three sites (N = 480). The between-site precision, between-lot precision, between-recalibration precision, betweenday precision, between-run precision, repeatability (within-run precision) and total precision (within-run, between-run, between-day, between-recalibration, between-lot and between-site) were calculated using a modified protocol, which was written based on the recommendations of CLSI® EP5-A2:
Pool A (389 U/mL):
- Between-site CV (%): 4.15
- Between-lot CV (%): 1.01
- Between-recalibration CV (%): 1.87
- Between-day CV (%): 0.00
- Between-run CV (%): 0.99
- Within-run CV (%): 3.40
- Total CV (%): 5.85
Pool B (75.3 U/mL):
- Between-site CV (%): 2.13
- Between-lot CV (%): 0.00
- Between-recalibration CV (%): 2.26
- Between-day CV (%): 1.08
- Between-run CV (%): 2.00
- Within-run CV (%): 3.50
- Total CV (%): 5.20
Pool C (18.9 U/mL):
- Between-site CV (%): 2.43
- Between-lot CV (%): 0.79
- Between-recalibration CV (%): 1.96
- Between-day CV (%): 0.74
- Between-run CV (%): 1.79
- Within-run CV (%): 3.35
- Total CV (%): 5.03
Measurement range: The measurement range of the VIDAS CA 125 II kit is: 4-600 U/mL.
Analytical detection limit: Based on a modification of CLSI® document EP17-A, LoB and LoQ detection limit results are estimated to be less than 4 U/mL.
Hook effect: No hook effect was found up to OC 125 reactive antigenic determinant concentrations of 200,000 U/mL.
Comparison with other test methods: One serum sample randomly chosen from each of the 77 women with ovarian cancer tested (133 samples) using the VIDAS CA (1) assay were compared to another commercially available assay. The equation representing the relationship between the two techniques is:
n = 210
Y = 0.93X - 58.10
95% Confidence interval for the intercept: -169.15 to 52.95
95% Confidence interval for the slope: 0.61 to 1.25
Range of samples: 4.0 - 31801 U/mL (VIDAS); 2.0 - 29940 U/mL (another commercially available assay)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Koposia
APR 1 0 2009
510(k) SUMMARY
VIDAS® CA 125 Il 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: | October 8, 2008 |
| Device Name | VIDAS® CA 125 II Assay |
B.
| Trade Name: | VIDAS® CA 125 II Assay |
|---|---|
| Common Name: | CA 125 |
| Classification Name: | Test, Epithelial Ovarian Tumor-Associated Antigen (CA125) |
C. Predicate Device Name
Trade Name:
TOSOH Medical, Inc. ST AIA Pack CA 125 Enzyme lmmunoassay
D. Device Description
VIDAS® CA 125 II is an automated quantitative test for use on the VIDAS instruments, for the measurement of CA 125 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 125 II is indicated for the serial measurement of OC 125 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with Stage IV (metastatic) ovarian cancer for disease progression or response to therapy. The VIDAS CA 125 II assay can also be used as an aid in the early detection of recurrence in previously treated Stage II and III ovarian cancer patients.
CA 125 II 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 M 11 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 M11 antibody fixed onto the interior wall of the SPR to capture the reactive
1
antigenic determinants present in the sample. Unbound components are eliminated during the washing steps. Alkaline phosphatase labeled mouse monoclonal OC 125 antibody (conjugate) is then incubated in the SPR where it binds with the OC 125 reactive antigenic determinant. Unbound conjugate is then eliminated during the washing steps.
During the final detection step, the substrate (4-Methyl-umbelliferyl 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 OC 125 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 125 II is an automated quantitative test for use on the VIDAS instruments, for the measurement of OC 125 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 125 II is indicated for the serial measurement of OC 125 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with ovarian cancer for disease progression or response to therapy. The VIDAS CA 125 Il assay can also be used as an aid in the detection of recurrence in previously treated ovarian cancer patients.
F. Technological Characteristics Summary
A general comparison of the similarities and differences of the VIDAS CA 125 II assay to the predicate device is presented in the table below.
| Item | VIDAS® CA 125 II Assay | TOSOH ST AIA-PACK
CA 125 (K023891) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General Comparison | | |
| Intended Use | VIDAS® CA 125 II is an automated
quantitative test for use on the VIDAS
instruments, for the measurement of
OC 125 reactive antigenic determinants
in human serum using the ELFA
technique (Enzyme Linked Fluorescent
Assay). The VIDAS CA 125 II is
indicated for the serial measurement of
OC 125 reactive antigenic determinants
as an aid in the monitoring of patients
previously diagnosed with ovarian
cancer for disease progression or
response to therapy. The VIDAS CA
125 II assay can also be used as an aid
in the detection of recurrence in
previously treated ovarian cancer
patients. | ST AIA-PACK CA 125 is designed for IN
VITRO DIAGNOSTIC USE ONLY for
the quantitative measurement of CA 125
in human serum on specific TOSOH
AIA System analyzers. ST AIA-PACK
CA 125 is to be used as an aid in
monitoring response to therapy for
patients with epithelial ovarian cancer.
Serial testing for patient CA 125 assay
values should be used in conjunction
with other clinical methods used for
monitoring ovarian cancer. |
| Specimen | Serum | Serum |
2
| Item | VIDAS® CA 125 II Assay | TOSOH ST AIA-PACK CA 125 (K023891) |
|---|---|---|
| Analyte | CA 125 | CA 125 |
| Antibody | mouse monoclonal anti-CA 125 | mouse monoclonal anti-CA 125 |
| Assay Principle | Two antibody "sandwich" binding of CA 125 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 125. 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 | 200 µL | 100 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 | 4.00 - 600.00 U/mL | 2.0 - 1,000 U/mL |
G. Performance Data
A summary of some of the non-clinical and clinical test results is presented in the tables below.
Precision:
Three serum samples were tested in duplicate in 40 different runs (2 runs per day over 20 sequential days) with 2 reagent lots using one instrument at each of three sites (N = 480). The between-site precision, between-lot precision, between-recalibration precision, betweenday precision, between-run precision, repeatability (within-run precision) and total precision (within-run, between-run, between-day, between-recalibration, between-lot and between-site) were calculated using a modified protocol, which was written based on the recommendations of CLSI® EP5-A2:
| Source | N | Pool A (389
U/mL) | Pool B (75.3 U
/mL) | Pool C (18.9 U
/mL) |
|---------------------------|-----|----------------------|------------------------|------------------------|
| | | CV (%) | CV (%) | CV (%) |
| Between-site | 480 | 4.15 | 2.13 | 2.43 |
| Between-lot | 480 | 1.01 | 0.00 | 0.79 |
| Between-
recalibration | 480 | 1.87 | 2.26 | 1.96 |
| Between-day | 480 | 0.00 | 1.08 | 0.74 |
| Between-run | 480 | 0.99 | 2.00 | 1.79 |
| Within-run | 480 | 3.40 | 3.50 | 3.35 |
| Total | 480 | 5.85 | 5.20 | 5.03 |
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Measurement range
The measurement range of the VIDAS CA 125 II kit is: 4-600 U/mL.
Analytical detection limit
Based on a modification of CLSI® document EP17-A , LoB and LoQ detection limit results are estimated to be less than 4 U/mL.
Hook effect
No hook effect was found up to OC 125 reactive antigenic determinant concentrations of 200,000 U/mL.
Comparison with other test methods
One serum sample randomly chosen from each of the 77 women with ovarian cancer tested Online of the disease that on the expected values (133
for the monitoring of the disease status (17 the expected values (133
samples) using the VIDAS CA (1) assay were compar equation represents the relationship between the two techniques.
n = 210 Y = 0.93X - 58.10 95% Confidence interval for the intercept: -169.15 to 52.95 95% Confidence interval for the slope: 0.61 to 1.25 Range of samples: 4.0 - 31801 U/mL (VIDAS); 2.0 - 29940 U/mL (another commercially available assay)
Image /page/3/Figure/9 description: The image is a scatter plot comparing 'vidas' and 'predicate'. The x-axis is labeled 'predicate' and ranges from 0 to 30000, while the y-axis is labeled 'vidas' and ranges from 0 to 35000. The plot includes two lines: one labeled 'Identity' and another labeled 'Deming fit (-58.10 + 0.93x)'. The Deming fit line appears to be a linear regression model fitted to the data points.
Scatter Plot with Deming Fit
4
H. Conclusion
.
The VIDAS® CA 125 II Assay is substantially equivalent to the Tosoh Medical, Inc. ST AIA Pack CA 125 Assay. .
.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 0 2009
BioMérieux, Inc. c/o Ms. Sandra L. Perreand Senior Director, North American Regulatory Affairs 595 Anglum Rd Hazelwood, MO 63042
Re: K080561
Trade/Device Name: VIDAS® CA 125 IITM Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: LTK Dated: April 07, 2009 Received: April 08, 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
6
Page 2 - Ms. Sandra L. Perreandl
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 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): K080561
Device Name: VIDAS® CA 125 II
Indication For Use:
VIDAS® CA 125 II is an automated quantitative test for use on the VIDAS instruments, for the measurement of OC 125 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 125 II is indicated for the serial measurement of OC 125 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with ovarian cancer for disease progression or response to therapy. The VIDAS CA 125 II assay can also be used as an aid in the detection of recurrence in previously treated ovarian cancer patients.
Prescription Use × (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)
Mana M Chan.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080561