The LOCI CA19-9 method is an in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. Measurements of CA 19-9 are indicated for the serial measurement of CA19-9 to aid in managing patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined.

The LOCI 7 CAL is an in vitro diagnostic product for the calibration of the Cancer Antigen 19-9 (CA19-9) method on the Dimension Vista® System.

Device Description

The CA19-9 method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCl® reagents include two synthetic bead reagents and a biotinylated anti-CA 19-9 monoclonal 1116-NS-19-9 anibody fragment. The first bead reacent (Chemibeads) is coated with an anti-CA 19-9 monoclonal antibody (1116-NS-19-9) and contains a chemilyminescent dye. The second bead reagent (Sensibeads) is coated with and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-CA 19-9-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 19-9 concentration in the sample when measured against a calibration curve.

The LOCI 7 calibrator is a liquid, frozen bovine serum albumin, based product containing CA 19-9 from human cell culture. The kit consists of ten vials, two vials per level (A-E), 2.0 mL per vial.

AI/ML Overview

This document is a 510(k) summary for a diagnostic test, not a study reporting on the device's performance against specific acceptance criteria. A 510(k) is a premarket notification demonstrating that the device is substantially equivalent to a legally marketed predicate device. Therefore, it does not typically include detailed acceptance criteria tables or specific studies proving the device meets those criteria in the way a clinical trial or performance evaluation report would.

However, based on the provided text, I can extract information related to the device's reported specifications and the general nature of the evidence presented for substantial equivalence.

Here's an analysis of the provided text in relation to your request, highlighting what is not available in this specific document:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria and reported device performance in the typical sense of a clinical study. Instead, it offers a "Comparison of Similarities and Differences" table between the new device (LOCI CA 19-9 Flex® Reagent Cartridge and LOCI 7 Calibrator) and its predicate devices. This comparison focuses on features such as intended use, sample type, measuring range, sample size, measurement principle, matrix, preparation, number of calibrator levels, target concentrations, and storage.

The document states: "Comparative testing described in the submission substa[ntiates substantial equivalence]" but does not provide the details of this testing or specific performance metrics with acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not available in the provided 510(k) summary. The summary refers to "comparative testing" but does not detail the sample size (number of patients or samples) or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not available in the provided 510(k) summary. Given that this is an in vitro diagnostic test for biomarker measurement, the ground truth would likely refer to the true concentration of CA 19-9, often established by reference methods or gravimetric preparation for calibrators/controls, rather than expert interpretation of images or clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not available in the provided 510(k) summary. Adjudication methods are typically relevant in studies involving human interpretation or subjective assessments, which is not the primary focus of validating an in vitro diagnostic assay like this.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/available. The device is an in vitro diagnostic reagent and calibrator for quantitative measurement of a biomarker, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are irrelevant to this device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable/available. The device is a laboratory assay, not an algorithm. Its performance is inherent to the chemical and physical processes of the assay itself when run on the specified instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For a quantitative in vitro diagnostic test, the "ground truth" for the test set (clinical samples) would typically be the true concentration of the analyte (CA 19-9) as determined by a highly accurate reference method, or for manufactured calibrators, it would be the gravimetrically prepared target concentration. Specific details are not provided in this summary, but the context implies it relates to accurate measurement of CA 19-9 levels.

For the calibrator (Dimension Vista® LOCI 7 Calibrator), the ground truth for its concentrations are "Target Concentrations: Level 1 (CAL A): 0 U/mL, Level 2 (CAL B): 30 U/mL, Level 3 (CAL C): 131 U/mL, Level 4 (CAL D): 525 U/mL, Level 5 (CAL E): 1050 U/mL". This acts as the "ground truth" for calibration.

8. The sample size for the training set

This information is not available in the provided 510(k) summary. For in vitro diagnostic devices, the concept of "training set" is generally not applied in the same way as for AI models. Assay development involves optimization and validation using various samples, but these are typically not categorized as a distinct "training set" in the context of a 510(k) summary.

9. How the ground truth for the training set was established

This information is not available in the provided 510(k) summary for the above reasons.

Summary Table of Device Specifications (from the "Similarities and Differences" comparison, not "Acceptance Criteria" actively met by a study):

Feature	LOCI CA 19-9 Flex® Reagent Cartridge (New Device)
Intended Use	Quantitative measurement of CA 19-9 in human serum, lithium heparin, and EDTA plasma on Dimension Vista® System. Aid in serial measurement for managing pancreatic cancer patients and monitoring disease status in confirmed cases with elevated CA 19-9.
Sample Type	Serum, lithium heparin, and EDTA plasma
Measuring Range	2-1000 U/mL
Sample Size	4 µL
Measurement	Chemiluminescent: Homogenous sandwich immunoassay based on LOCI® technology

Feature	LOCI 7 Calibrator (New Device)
Intended Use	In vitro diagnostic product for the calibration of the Cancer Antigen 19-9 (CA19-9) method on the Dimension Vista® System.
Matrix	Bovine serum albumin-based matrix
Preparation	Liquid: Provided ready to use.
Number of Calibrator Levels	5 levels
Target Concentrations	Level 1 (CAL A): 0 U/mL, Level 2 (CAL B): 30 U/mL, Level 3 (CAL C): 131 U/mL, Level 4 (CAL D): 525 U/mL, Level 5 (CAL E): 1050 U/mL
Storage	Store at -15 to -25 °C.

Study Details Mentioned (Limited):

Type of Study: The document refers to "Comparative testing" to demonstrate substantial equivalence to the predicate device (ADVIA Centaur CA 19-9 assay, K031393). This implies analytical performance studies (e.g., precision, accuracy, linearity, interference) were performed to show that the new device performs similarly to the predicate. However, specific results or detailed methodologies are not included in this summary.
Purpose: To demonstrate substantial equivalence to legally marketed predicate devices.
Conclusion: The LOCI CA 19-9 method and LOCI 7 calibrator are considered substantially equivalent to their respective predicate devices based on the comparative testing described in the full submission.

Summary

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510(k) Summary of Safety and Effectiveness for the

LOCI CA 19-9 (CA19-9) Flex® Reagent Cartridge

2011

Dimension Vista® LOCI 7 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: K100375

B. Date of Preparation: February 11, 2010

C. Proprietary and Established Names:

LOCI CA 19-9 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 CA 19-9 Flex® Reagent Cartridge:

Regulation section: 21 CFR § 866.6010 Tumor-Associated antigen immunological test system
Classification: Class II
Product Code: NIG - System, Test, Carbohydrate Antigen (CA 19-9) for Monitoring and Management of Pancreatic Cancer

এ . 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 CA19-9 Flex® Reagent Cartridge is the CA 19-9 Assay for the ADVIA Centaur® System previously cleared under K031393.

The predicate device used to demonstrate substantial equivalence to the Dimension Vista® LOCI 7 Calibrator is the ADVIA Centaur® Calibrator 9 previously cleared under K031393.

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G. Device Description:

The LOCI 7 calibrator is a liquid, frozen bovine serum albumin, based product containing CA 19-9 from human cell culture. The kit consists of ten vials, two vials per level (A-E), 2.0 mL per vial.

H. Intended Use:

The CA19-9 method is an in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum and (lithium heparin and EDTA plasma on the Dimension Vista® System. Measurements of CA 19-9 are indicated for the serial measurement of CA19-9 to aid in managing patients diagnosed with cancers of the test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the alby conort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined.

The LOCI 7 CAL is an in vitro diagnosic product for the Calibration of the Cancer Antigen 19-9 (CA 19-9 method on the Dimension Vista® system.

I. Substantial Equivalence Information:

The LOCI CA 19-9 method is substantially equivalent to other CA 19-9 test systems such as the ADV/A Centaur CA 19-9 assay (K031393). The LOCI 7 calibrator is substantially equivalent to other calibrators such as the ADVIA Centaur® Calibrator 9 calibrator (K031393). The following table provides a comparison similarities and differences:

Feature	LOCI CA 19-9 Flex® reagent cartridge	CA 19-9 Assay for the ADVIA Centaur System (K030393)
Intended Use	The CA19-9 method is an in vitro diagnostic test for the quantitative measurement of the CA 19-9 tumor-associated antigen in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. Measurements of CA 19-9 are indicated for the serial measurement of CA19-9 to aid in managing patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined.	The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative, measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. The test is useful as an aid in monitoring of disease status in those patients having confirmed pancreatic cancer who have levels of serum CA 19-9 at some point in their disease process exceeding the median concentration determined for the apparently healthy cohort. CA 19-9 values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is determined.

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Sample Type	Serum and lithium heparin and EDTA plasma	Serum
Measuring Range	2-1000 U/mL	1.2-700 U/mL
Sample Size	4 µL	75 µL
Measurement	Chemiluminescent:Homogenous sandwich immunoassay based on LOCI® technology	Chemiluminescent:Two site sandwich immunoassay using direct chemiluminometric technology

Feature	LOCI 7 calibrator	ADVIA Centaur® Calibrator 9previously cleared under K031393
Intended Use	The LOCI 7 CAL is an in vitrodiagnostic product for the calibration ofthe Cancer Antigen 19-9 (CA19-9)method on the Dimension Vista®System	For the in vitro diagnostic use incalibrating ADVIA® Centaur or ACS:180® 19-9 assays.
Matrix	Bovine serum albumin-based matrix	Bovine serum-based matrix
Preparation	Liquid:Provided ready to use.	Lyophilized.
Number ofCalibratorLevels	5 levels	2 levels
	Target Concentrations:Level 1 (CAL A): 0 U/mLLevel 2 (CAL B): 30 U/mLLevel 3 (CAL C): 131 U/mLLevel 4 (CAL D): 525 U/mLLevel 5 (CAL E): 1050 U/mL	LowHigh
Storage	Store at -15 to -25 °C.	Store at 2 to 8°C.

J. Conclusion:

The LOCI CA 19-9 method is substantially equivalent to other CA 19-9 test as the ADVA Contaur CA 19-9 assay
(K031393). Comparative testing described in the submission substa

The LOCI 7 calibrator is substantially equivalent to other calibrators such as the ADVIA Centaur® Calibrator 9 calibrator 9 calibrator 9 calibrator 9 calibrator 9 calibrator

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Image /page/3/Picture/0 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 an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with a single staff entwined by a serpent.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Druq 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 0 6 2011

Re: K100375

Trade/Device Name: Dimension Vista® LOCI CA19-9 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: NIG, 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related

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Page 2 – Ms. Pamela A. Jurga

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,

i mchen

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): k 100375

Device Name:

Dimension Vista® LOCI 7 Calibrator

Indications for Use:

The LOCI 7 CAL is an in vitro diagnostic product for the calibration of the Cancer Antigen 19-9
(CA19-9) method 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) o=============================================================================================================================================================================

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 K100375

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Indications for Use Statement

510(k) Number (if known): 《+00375

Device Name:

Dimension Vista® CA 19-9 Flex® Reagent

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)

waaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa 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 K100375

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.