(432 days)
Not Found
No
The device description details a homogeneous, sandwich chemiluminescent immunoassay based on LOCI technology, which is a standard biochemical method for measuring antigen concentration. There is no mention of AI or ML in the intended use, device description, or the "Mentions AI, DNN, or ML" section.
No
The device is an in vitro diagnostic test used to measure CA 125 antigen, which aids in monitoring disease progress or response to therapy for patients with epithelial ovarian cancer, rather than directly treating a condition.
Yes
The text explicitly states, "The LOCI CA 125 II™ method is an in vitro diagnostic test for the quantitative measurement of CA 125 antigen in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System." Additionally, it mentions its use as "an aid in monitoring disease progress or response to therapy or for the recurrent or residual disease for patients with epithelial ovarian cancer," which describes a diagnostic function.
No
The device description clearly outlines physical components (beads, antibodies, dyes) and a chemical reaction process, indicating it is a hardware-based in vitro diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The LOCI CA 125 II™ method is an in vitro diagnostic test..." and "The LOCI 6 CAL is an in vitro diagnostic product...".
- Nature of the Test: The device measures the concentration of CA 125 antigen in human serum and plasma. This is a test performed on samples taken from the body, which is the definition of an in vitro diagnostic test.
- Intended Use: The intended use is to aid in monitoring disease progress or response to therapy for patients with epithelial ovarian cancer. This is a medical purpose for which an IVD is used.
- Calibration: The LOCI 6 CAL is specifically described as a calibrator for the CA 125 method, which is a component used in the process of performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The LOCI CA 125 II™ method is an in vitro diagnostic test for the quantitative measurement of CA 125 antigen in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. Measurements of CA 125 are used as an aid in monitoring disease progress or response to therapy or for the recurrent or residual disease 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. It is recommended that the LOCI CA 125 Il method be used in conjunction with signs and symptoms of a clinical evaluation by a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.
The LOCI 6 CAL is an in vitro diagnostic product for the calibration of Alpha-Fetoprotein (AFP), Carcinocmbryonic Antigen (CEA), and CA 125 (CA125) methods on the Dimension Vista® System.
Product codes (comma separated list FDA assigned to the subject device)
LTK, JIX
Device Description
The LOCI CA 125Il™ method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-CA 125 monoclonal antibody (M11) fragment. The first bead reagent (Chemibeads) is coated with an anti-CA125 monoclonal antibody (OC 125) and contains a chemiluminescent dye. The use of the M11 antibody in combination with OC 125 defines this method as a second generation CA 125 assay. 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-CA 125-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 CA 125 concentration in the sample.
The LOCI 6 calibrator is a multi-analyte liquid, frozen bovine serum albumin based product containing Alpha-Fetoprotein from human cord blood, Carcinoembryonic Antigen from human cell culture and CA 125 from human cell culture. The kit consists of ten vials per level (A-E), 2.0 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
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
physician trained and experienced in the management of gynecological cancers.
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)
Comparative testing described in the submission report demonstrates substantial equivalent performance.
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.
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.
0
510(k) Summary of Safety and Effectiveness for the
Dimension Vista® LOCI CA 125 (CA125) Flex® Reagent Cartridge
Dimension Vista® LOCI® 6 Calibrator
APR 1 2 2011
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.
A. 510(k) Number: K100321
B. Date of Preparation: February 2, 2010
C. Proprietary and Established Names:
LOCI CA 125 Flex® Reagent Cartridge
Dimension Vista® LOCI 6 Calibrator
D. Applicant:
Siemens Healthcare Diagnostics Inc.
P.O. Box 6101, Newark, DE 19714-6101
Pamela A. Jurga, Regulatory & Clinical Affairs Specialist
Office Number: (302) 631-8891 fax Number: (302) 631-6299
E. Regulatory Information:
LOCI CA125 Flex® Reagent Cartridge:
-
Regulation section: 21 CFR § 866.6010 Tumor-Associated antigen immunological test system
-
Classification: Class II
-
Product Code: LTK - Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
-
Panel: Immunology
LOCI 6 Calibrator:
-
Regulation section: 21 CFR § 862.1150 Calibrator
-
Classification: Class II
-
Product Code: JIX - Calibrator, Multi-Analyte Mixture
-
Panel: Immunology
F. Predicate Device:
The predicate device used to demonstrate substantial equivalence to the LOCI CA125|I™ Flex® Reagent Cartridge is the CA 125II Assay for the ADVIA Centaur System previously cleared under K020828.
· \
1
The predicate device used to demonstrate substantial equivalence to the Dimension Vista® LOCI 6 Calibrator is the Dimension Vista® LOCI 5 Calibrator previously cleared under K071597 and K071603.
G. Device Description:
The LOCI CA 125Il™ method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-CA 125 monoclonal antibody (M11) fragment. The first bead reagent (Chemibeads) is coated with an anti-CA125 monoclonal antibody (OC 125) and contains a chemiluminescent dye. The use of the M11 antibody in combination with OC 125 defines this method as a second generation CA 125 assay. 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-CA 125-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 CA 125 concentration in the sample.
The LOCI 6 calibrator is a multi-analyte liquid, frozen bovine serum albumin based product containing Alpha-Fetoprotein from human cord blood, Carcinoembryonic Antigen from human cell culture and CA 125 from human cell culture. The kit consists of ten vials per level (A-E), 2.0 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
H. Intended Use:
The LOCI CA 125 II™ method is an in vitro diagnostic test for the quantitative measurement of CA 125 antigen in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. Measurements of CA 125 are used as an aid in monitoring disease progress or response to therapy or for the recurrent or residual disease for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in coniunction with other clinical methods used for monitoring ovarian cancer. It is recommended that the LOCI CA 125 Il method be used in conjunction with signs and symptoms of a clinical evaluation by a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.
The LOCI 6 CAL is an in vitro diagnostic product for the calibration of Alpha-Fetoprotein (AFP), Carcinoembryonic Antigen (CEA) and Cancer Antigen125II™ (CA125) methods on the Dimension Vista® system.
l. Substantial Equivalence Information:
The LOCI CA 125||™ method is substantially equivalent to other CA125 test systems such as the ADVA Centaur CA125Il assay (K020828). The LOCI 6 calibrator is substantially equivalent to other calibrators such as the LOCI 5 calibrator (K071597 and K071603). The following table provides a comparison of the important similarities and differences:
| Feature | LOCI CA 125II™ Flex® Reagent
cartridge | CA 125II Assay for the ADVIA Centaur
System (K020828) |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LOCI CA 125 II™ method is an in vitro
diagnostic test for the quantitative
measurement of CA 125 antigen in human
serum and lithium heparin and EDTA
plasma on the Dimension Vista® System.
Measurements of CA 125 are used as an
aid in monitoring disease progress or
response to therapy or for the recurrent
or residual disease 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 | For in vitro diagnostic use in the
quantitative, serial determination in human
serum and to aid in the management of
patients with ovarian carcinoma using the
ADVIA Centaur and ADVIA Centaur XP
systems. The test is intended for use as an
aid in monitoring patients who are clinically
free of disease and should be used in
conjunction with other clinical methods used
for monitoring ovarian cancer. Serial
testing for CA 125 in the serum of patients
who are clinically free of disease should be
used in conjunction with other clinical
methods used for early detection of cancer
recurrence. The test is also intended for |
2
| | cancer. It is recommended that the LOCI
CA 125 II method be used in conjunction
with signs and symptoms of a clinical
evaluation by a physician trained and
experienced in the management of
gynecological cancers. This assay is not
intended for screening or diagnosis of
ovarian cancer or for use on any other
system. | use as an aid in the management of ovarian
cancer patients with metastatic disease by
monitoring the progression or regression of
disease in response to treatment. It is
recommended that the ADVIA Centaur CA
125 II assay be used under the order of a
physician trained and experienced in the
management of gynecological cancers.
This assay is not intended for screening or
diagnosis of ovarian cancer or for use on
any other system. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sample Type | Serum and lithium heparin and EDTA
plasma | Serum |
| Measuring
Range | 1.5 -1000 U/mL | 2-600 U/mL |
| Sample Size | 5 µL | 50 µL |
| Measurement | Chemiluminescent: | Chemiluminescent: |
| | Homogenous sandwich immunoassay
based on LOCI® technology | Two site sandwich immunoassay using
direct chemiluminometric technology |
| Feature | LOCI 6 calibrator | LOCI 5 Calibrator
K071597 and K071603 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LOCI 6 CAL is an in vitro
diagnostic product for the calibration of
Alpha-Fetoprotein (AFP),
Carcinoembryonic Antigen (CEA) and
Cancer Antigen12511™ (CA125)
methods on the Dimension Vista®
system. | an in vitro diagnostic product for the
calibration of Alpha-Fetoprotein (AFP),
Carcinoembryonic Antigen (CEA)
methods on the Dimension Vista®
system. |
| Matrix | BSA-based matrix | BSA-based matrix |
| Preparation | Liquid:
Provided ready to use. | Liquid:
Provided ready to use. |
| Target
Concentrations
CA 125 | Level 1 (CAL A): 0
U/mL
Level 2 (CAL B): 8
U/mL
Level 3 (CAL C): 60
U/mL
Level 4 (CAL D): 250 U/mL
Level 5 (CAL E): 1050 U/mL | None |
| Storage | Store at -15 to - 25 °C. | Store at 2 to 10°C. |
J. Conclusion:
The LOCI CA 125II™ method Flex® reagent cartridge is substantially equivalent to the ADVIA Centaur CA125II assay (K020828). Comparative testing described in the submission report demonstrates substantial equivalent performance.
The Dimension Vista® LOCI 6 CAL is substantially equivalent to the Dimension Vista® LOCI 5 CAL (K071597 and K071603).
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, abstract style, with flowing lines suggesting movement. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Siemens Healthcare Diagnostics c/o Ms. Pamela A. Jurga Regulatory and Clinical Affairs Specialist PO Box 6101 Mailstop 514 Newark, DE 19714-6101
APR 1 2 201
Re: K100321
Trade/Device Name: Dimension Vista® LOCI CA125 Flex® reagent cartridge Dimension Vista® LOCI 6 Calibrator Regulation Number: 21 CFR §866.6010 Regulation Name: Tumor-Associated antigen immunological test system Regulatory Class: Class II Product Code: LTK. JIT Dated: March 31, 2011 Received: April 1, 2011
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.
If your device is classified (see above) into class II (Special Controls), 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
4
Page 2 – Ms. Pamela A. Jurga
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Marie 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
5
Indications for Use
510(k) Number (if known):
Device Name: Dimension Vista® CA 125 Flex® Reagent
Indications For Use:
The LOCI CA 125 II™ method is an in vitro diagnostic test for the quantitative measurement of CA 125 antigen in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. Measurements of CA 125 are used as an aid in monitoring disease progress or response to therapy or for the recurrent or residual disease 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. It is recommended that the LOCI CA 125 Il method be used in conjunction with signs and symptoms of a clinical evaluation by a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
Reena Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of
K100321 510K
6
Indications For Use Statement
510(k) Number (if known):
Device Name:
Dimension Vista® LOCI 6 Calibrator
Indications for Use:
The LOCI 6 CAL is an in vitro diagnostic product for the calibration of Alpha-Fetoprotein (AFP), Carcinocmbryonic Antigen (CEA), and CA 125 (CA125) methods on the Dimension Vista® System.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
-------------------------------------==============================================================================================================================================================================
Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)
Reene Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and 9 afety
510K k/0032)