DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604

K100375 · Siemens Healthcare Diagnostics, Inc. · NIG · Apr 6, 2011 · Immunology

Device Facts

• Record ID: K100375
• Device Name: DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: NIG · Immunology
• Decision Date: Apr 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

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 (CA 19-9) method on the Dimension Vista® system.

Device Story

The LOCI CA 19-9 Flex® Reagent Cartridge is an in vitro diagnostic immunoassay for the Dimension Vista® System. It uses LOCI® technology: a homogeneous, sandwich chemiluminescent immunoassay. Input: 4 µL of human serum, lithium heparin, or EDTA plasma. Process: Sample is incubated with biotinylated anti-CA 19-9 monoclonal antibody (1116-NS-19-9) and Chemibeads (coated with anti-CA 19-9 antibody and chemiluminescent dye). Sensibeads (coated with photosensitizer dye) are added to form bead-pair immunocomplexes. Illumination at 680 nm triggers singlet oxygen release from Sensibeads, diffusing to Chemibeads to initiate a chemiluminescent reaction measured at 612 nm. Output: Quantitative CA 19-9 concentration derived from a calibration curve. Used in clinical laboratories by trained personnel to monitor disease status in pancreatic cancer patients. Results are interpreted by physicians alongside other clinical data to aid in patient management.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing and analytical performance comparisons between the subject device and the predicate assay.

Technological Characteristics

Homogeneous sandwich chemiluminescent immunoassay using LOCI® technology. Reagents: synthetic beads (Chemibeads with chemiluminescent dye, Sensibeads with photosensitizer dye) and biotinylated anti-CA 19-9 monoclonal antibody. Energy source: 680 nm illumination. Dimensions/Form factor: reagent cartridge for Dimension Vista® System. Connectivity: integrated with Dimension Vista® 1500 instrument. Calibration: 5-level liquid calibrator (bovine serum albumin matrix).

Indications for Use

Indicated for serial measurement of CA 19-9 to aid in managing patients diagnosed with exocrine pancreatic cancer; useful for monitoring disease status in patients with confirmed pancreatic cancer who have baseline serum CA 19-9 levels exceeding the median concentration of an apparently healthy cohort.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CA 19-9 Assay for the ADVIA Centaur® System (k031393)
• ADVIA Centaur® Calibrator 9 (k031393)

Submission Summary (Full Text)

{0}------------------------------------------------

#### 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: [phone] fax Number: [phone]

#### E. Regulatory Information:

LOCI CA 19-9 Flex® Reagent Cartridge:

1. Regulation section: 21 CFR § 866.6010 Tumor-Associated antigen immunological test system

2. Classification: Class II

3. 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
- 2. Classification: Class II
- 3. Product Code: JIT Calibrator, Secondary

4. 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.

{1}------------------------------------------------

### G. 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.

#### 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 <i>in vitro</i> 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 <i>in vitro</i> 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. |

{2}------------------------------------------------

| 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:<br><br>Homogenous sandwich immunoassay based on LOCI® technology | Chemiluminescent:<br><br>Two site sandwich immunoassay using direct chemiluminometric technology |

| Feature | LOCI 7 calibrator | ADVIA Centaur® Calibrator 9<br>previously cleared under k031393 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Intended Use | The LOCI 7 CAL is an <i>in vitro</i><br>diagnostic product for the calibration of<br>the Cancer Antigen 19-9 (CA19-9)<br>method on the Dimension Vista®<br>System | For the <i>in vitro</i> diagnostic use in<br>calibrating ADVIA® Centaur or ACS:<br>180® 19-9 assays. |
| Matrix | Bovine serum albumin-based matrix | Bovine serum-based matrix |
| Preparation | Liquid:<br>Provided ready to use. | Lyophilized. |
| Number of<br>Calibrator<br>Levels | 5 levels | 2 levels |
| | Target Concentrations:<br>Level 1 (CAL A): 0 U/mL<br>Level 2 (CAL B): 30 U/mL<br>Level 3 (CAL C): 131 U/mL<br>Level 4 (CAL D): 525 U/mL<br>Level 5 (CAL E): 1050 U/mL | Low<br>High |
| 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

{3}------------------------------------------------

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

{4}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

# 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

{6}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known): 《+00375

Device Name:

Dimension Vista® CA 19-9 Flex® Reagent

## Indications for Use:

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.

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