(437 days)
Not Found
No
The device description details a homogeneous, sandwich chemiluminescent immunoassay based on LOCI technology, which is a standard laboratory technique for measuring biomarkers. There is no mention of AI, ML, or any computational algorithms beyond standard signal processing for quantitative measurement.
No
This device is an in vitro diagnostic test used to measure CA 15-3 levels, aiding in the management and monitoring of breast cancer patients; it does not directly treat or provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the LOCI CA15-3 method is "an in vitro diagnostic test."
No
The device description clearly details physical reagents (beads, antibodies, calibrator) and a chemiluminescent immunoassay process, indicating it is a hardware-based in vitro diagnostic test, not software-only.
Based on the provided text, both devices are explicitly stated to be In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use / Indications for Use: Both descriptions clearly state "is an in vitro diagnostic test" or "is an in vitro diagnostic product".
- Device Description: The description of the LOCI CA 15-3 method details a laboratory-based immunoassay using biological samples (serum and plasma) to measure a specific analyte (CA 15-3). The LOCI 7 CAL is described as a calibrator for these types of methods. These are characteristic components of IVD systems.
Therefore, the answer is Yes.
N/A
Intended Use / Indications for Use
The LOCI CA15-3 method is an in vitro diagnostic test for the quantitative measurement of CA 15-3 in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. When used in conjunction with other clinical and diagnostic procedures, serial testing with the LOCI CA 15-3 assay may be used as an aid in the management of previously treated stage II and III breast cancer patients and for monitoring response to therapy in metastatic breast cancer patients.
The LOCI 7 CAL is an in vitro diagnostic product for the calibration of Cancer Antigen 15-3 (CA 15-3) and Cancer Antigen 19-9 (CA 19-9) methods on the Dimension Vista® system.
Product codes (comma separated list FDA assigned to the subject device)
MOI, JIT, JIX
Device Description
The LOCI CA 15-3 (CA 15-3) method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-CA 15-3 monoclonal antibody (DF3) fragment. The first bead reagent (Chemibeads) is coated with an anti-CA15-3 monoclonal antibody (115DB) and contains a chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-CA 15-3-biotinylated antibody sandwiches. Sensibeads are added and bind 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 15-3 concentration in the sample.
The LOCI 7 calibrator is a liguid, frozen, bovine serum albumin, based product containing CA 15-3 from human cell culture. The kit consists of ten vials two 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
Breast
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)
Not Found
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
K10034Y
APR 1 8 2011
510(k) Summary of Safety and Effectiveness for the
LOCI CA 15-3 (CA 15-3) Flex® Reagent Cartridge
Dimension Vista® LOCI® Calibrator
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: K100344
B. Date of Preparation: January 27, 2010
C. Proprietary and Established Names:
LOCI CA 15-3 Flex® Reagent Cartridge
Dimension Vista® LOCI 7 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 CA15-3 Flex® Reagent Cartridge:
-
Regulation section: 21 CFR § 866.6010 Tumor-Associated antigen immunological test system
-
Classification: Class II
-
Product Code: MOI - System, Test, Immunological, Antigen, Tumor
4 . Panel: Immunology
LOCI 7 Calibrator:
-
- Regulation section: 21 CFR § 862.1150 Calibrator
-
- Classification: Class II
-
- Product Code: JIT Calibrator, Secondary
- Panel: Immunology
F. Predicate Device:
The predicate device used to demonstrate substantial equivalence to the LOCI CA 15-3 Flex® Reagent Cartridge is the CA 15-3 Assay for the ADVIA Centaur System previously cleared under K012357
The predicate device used to demonstrate substantial equivalence to the Dimension Vista® LOCI 7 Calibrator for the Access® BR Monitor Assay previously cleared under K072612 .
1
G. Device Description:
The LOCI CA 15-3 (CA 15-3) method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-CA 15-3 monoclonal antibody (DF3) fragment. The first bead reagent (Chemibeads) is coated with an anti-CA15-3 monoclonal antibody (115DB) and contains a chemiluminescent dye. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-CA 15-3-biotinylated antibody sandwiches. Sensibeads are added and bind 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 15-3 concentration in the sample.
The LOCI 7 calibrator is a liguid, frozen, bovine serum albumin, based product containing CA 15-3 from human cell culture. The kit consists of ten vials two 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 15-3 method is an in vitro diagnostic test for the quantitative measurement of CA 15-3 in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. When used in conjunction with other clinical and diagnostic procedures, serial testing with the LOCI CA 15-3 assay may be used as an aid in the management of previously treated stage II and III breast cancer palients and for monitoring response to therapy in metastatic breast cancer palients.
The LOCI 7 CAL is an in vitro diagnostic product for the calibration of Cancer Antigen 15-3 (CA 15-3) and Cancer Antigen 19-9 (CA 19-9) methods on the Dimension Vista® system.
I. Substantial Equivalence Information:
The LOCI CA 15-3 method is substantially equivalent to other CA15-3 test systems such as the ADVA Centaur CA15-3 assay (K012357). The LOCI 7 calibrator is substantially equivalent to other calibrators such as the CA 15-3 Assay for the ADVA Centaur System (K012357). The following table provides a comparison of the important similarities and differences:
| Feature | LOCI CA 15-3 Flex® reagent cartridge | CA 15-3® Assay for the ADVIA Centaur
System (K012357) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LOCI CA15-3 method is an in vitro
diagnostic test for the quantitative
measurement of CA 15-3 in human serum
and lithium heparin and EDTA plasma on
the Dimension Vista® System. When used
in conjunction with other clinical and
diagnostic procedures, serial testing with
the LOCI CA 15-3 assay may be used as
an aid in the management of previously
treated stage II and III breast cancer
patients and for monitoring response to
therapy in metastatic breast cancer
patients. | The ADVIA Centaur CA 15-3 assay is an in
vitro diagnostic test for the quantitative
serial determination of cancer antigen CA
15-3 in human serum using the ADVIA
Centaur and the ADVIA Centaur XP
systems. When used in conjunction with
other clinical and diagnostic procedures,
serial testing with the ADVIA Centaur CA
15-3 assay is useful for monitoring the
course for disease and therapy in
metastatic breast cancer patients, and for
detection of recurrence in previously treated
Stage II, with greater than two positive
lymph nodes, or Stage III breast cancer
patients. This assay is not intended for use
on any other system. |
| Sample Type | Serum, lithium heparin and EDTA plasma | Serum |
| Measuring
Range | 1.0-300.0 U/mL | 0.5-200 U/mL |
| Sample Size | 1 µL | 20 µL |
| Measurement | Chemiluminescent:
Homogenous sandwich immunoassay
based on LOCI® technology | Chemiluminescent:
Two site sandwich immunoassay using
direct chemiluminometric technology |
2
| Feature | LOCI 7 calibrator | Access BR Monitor (CA 15-3 Antigen)
Assay on the Access Immunoassay
Systems
(K072612) |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Intended Use | The LOCI 7 CAL is an in vitro diagnostic
product for the calibration of Cancer Antigen
15-3 (CA 15-3) and Cancer Antigen 19-9
(CA 19-9) methods on the Dimension
Vista® system. | For in vitro diagnostic use for the calibration
the Access BR Monitor (CA 15-3 Antigen)
Assay. |
| Matrix | Bovine Serum Albumin | Bovine Serum Albumin |
| Levels | 5 levels at approximately 0, 20, 60, 150, 315
U/mL | 6 levels at approximately 0, 10, 50, 100, 500
and 1000 U/mL |
| Preparation | Liquid | Lyophilized |
| Storage | Store at -25 to -15 °C. | Store at 2 to 8°C. |
J. Conclusion:
The LOCI CA 15-3 method Flex® reagent cartridge is substantially equivalent to the ADVA Centaur CA 15-3-3 Assay previously Triber of Fr o thanis Proles on a substantialy equivalent to the ACCESS BR Monito (CA 15-3 Antigen)
cleared under K012512. The LOCl T calibrator is substantialy equivalent re equivalent performance.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with its wings forming a distinctive, flowing shape.
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 8 2011
Re: K100344
Trade/Device Name: Dimension Vista® LOCI CA 15-3 Flex® reagent cartridge Dimension Vista® LOCI 7 Calibrator Regulation Number: 21 CFR §866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: MOI, JIX Dated: April 11, 2011 Received: April 12, 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/ReportalProblem/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.
Thomas 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 Statement
510(k) Number (if known): K100344
Device Name: Dimension Vista® LOCI CA 15-3 Flex® reagent cartridge
Indications for Use:
The LOCI CA15-3 method is an in vitro diagnostic test for the quantitative measurement of CA 15-3 in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. When used in conjunction with other clinical and diagnostic procedures, serial testing with the LOCI CA 15-3 assay may be used as an aid in the management of previously treated stage II and III breast cancer patients and for monitoring response to therapy in metastatic breast cancer patients.
Prescription Use X (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)
Reena Philip
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K100344
6
Indications for Use Statement
510(k) Number (if known): K100344
Device Name:
Dimension Vista® LOCI 7 Calibrator
Indications for Use:
The LOCI 7 CAL is an in vitro diagnostic product for the calibration of Cancer Antigen 15-3 (CA 15-3) and Cancer Antigen 19-9 (CA 19-9) 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)
(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
510K K100344