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.

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.

AI/ML Overview

The provided document is a 510(k) summary for an in vitro diagnostic device (IVDD), the LOCI CA 15-3 Flex® Reagent Cartridge, and its associated calibrator. IVDDs, particularly those for tumor markers, are typically evaluated through analytical performance studies rather than clinical studies with patient outcomes as endpoints, which are more common for AI/ML devices or therapeutic interventions.

The document does not contain the information requested in the prompt regarding acceptance criteria and performance data from a "study that proves the device meets the acceptance criteria." Specifically, it lacks:

A table of acceptance criteria and reported device performance: The document compares the intended use, sample type, measuring range, sample size, and measurement method of the new device to its predicate, but these are not "acceptance criteria" in the sense of performance metrics (like sensitivity, specificity, accuracy, precision, etc.) and their corresponding measured values.
Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set size, and how training ground truth was established: These details are typical for studies involving diagnostic algorithms, particularly those using AI/ML, and are not found in this 510(k) summary for a traditional immunoassay and calibrator.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices, as is standard for 510(k) submissions. The substantial equivalence is argued based on similarities in intended use, technology, and analytical characteristics (though specific performance metrics are not detailed here beyond measuring range).

Therefore, I cannot fulfill the request to provide acceptance criteria and study details based on the provided text.

The document primarily states:

The LOCI CA 15-3 method is a quantitative measurement of CA 15-3 using a homogeneous, sandwich chemiluminescent immunoassay.
Its intended use is 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, in conjunction with other clinical and diagnostic procedures.
The LOCI 7 CAL is for the calibration of CA 15-3 and CA 19-9 methods.
Substantial equivalence is claimed against the ADVIA Centaur CA 15-3 assay (K012357) for the reagent cartridge and the Access® BR Monitor Assay (K072612) for the calibrator.

To obtain the detailed performance data (e.g., precision, accuracy, linearity, analytical sensitivity, etc.) and acceptance criteria that were likely part of the original 510(k) submission, one would need to access the full 510(k) submission packet, which is generally not publicly available in its entirety beyond the summary.

Summary

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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:

1. Regulation section: 21 CFR § 862.1150 Calibrator
1. Classification: Class II
1. 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 .

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G. Device Description:

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 CentaurSystem (K012357)
Intended Use	The LOCI CA15-3 method is an in vitrodiagnostic test for the quantitativemeasurement of CA 15-3 in human serumand lithium heparin and EDTA plasma onthe Dimension Vista® System. When usedin conjunction with other clinical anddiagnostic procedures, serial testing withthe LOCI CA 15-3 assay may be used asan aid in the management of previouslytreated stage II and III breast cancerpatients and for monitoring response totherapy in metastatic breast cancerpatients.	The ADVIA Centaur CA 15-3 assay is an invitro diagnostic test for the quantitativeserial determination of cancer antigen CA15-3 in human serum using the ADVIACentaur and the ADVIA Centaur XPsystems. When used in conjunction withother clinical and diagnostic procedures,serial testing with the ADVIA Centaur CA15-3 assay is useful for monitoring thecourse for disease and therapy inmetastatic breast cancer patients, and fordetection of recurrence in previously treatedStage II, with greater than two positivelymph nodes, or Stage III breast cancerpatients. This assay is not intended for useon any other system.
Sample Type	Serum, lithium heparin and EDTA plasma	Serum
MeasuringRange	1.0-300.0 U/mL	0.5-200 U/mL
Sample Size	1 µL	20 µL
Measurement	Chemiluminescent:Homogenous sandwich immunoassaybased on LOCI® technology	Chemiluminescent:Two site sandwich immunoassay usingdirect chemiluminometric technology

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Feature	LOCI 7 calibrator	Access BR Monitor (CA 15-3 Antigen)Assay on the Access ImmunoassaySystems(K072612)
Intended Use	The LOCI 7 CAL is an in vitro diagnosticproduct for the calibration of Cancer Antigen15-3 (CA 15-3) and Cancer Antigen 19-9(CA 19-9) methods on the DimensionVista® system.	For in vitro diagnostic use for the calibrationthe Access BR Monitor (CA 15-3 Antigen)Assay.
Matrix	Bovine Serum Albumin	Bovine Serum Albumin
Levels	5 levels at approximately 0, 20, 60, 150, 315U/mL	6 levels at approximately 0, 10, 50, 100, 500and 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.

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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

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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

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Indications for Use Statement

510(k) Number (if known): K100344

Device Name: Dimension Vista® LOCI CA 15-3 Flex® reagent cartridge

Indications for Use:

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

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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

Regulation Number and Section

§ 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.