K Number

Device Name

DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)

Manufacturer

DADE BEHRING, INC.

Date Cleared

2008-06-25

(379 days)

Product Code

DHX JIX

Regulation Number

866.6010

Intended Use

The CEA method is an in vitro diagnostic test for the quantitative measurement of carcinoembryonic antigen in human serum and sodium or lithium heparinized plasma on the Dimension Vista System. Measurements of carcinoembryonic antigen are used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed. For the calibration of the Carcinoembryonic Antigen (CEA) method on the Dimension Vista® System.

Device Description

Dimension Vista® CEA Flex® reagent cartridge: The CEA method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-CEA monoclonal antibody fragment. The first bead reagent (Chemibeads) is coated with an anti-CEA monoclonal antibody and contains 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-CEA-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Ulumination 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 CEA concentration in the sample. Dimension Vista® LOCI 5 Calibrator: LOCI 5 CAL is a liquid, multi-analyte, bovine serum albumin based product containing CEA from human tissue culture.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K031270

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic immunoassay based on chemiluminescent technology. There is no mention of AI or ML in the device description, intended use, performance studies, or any other section. The analysis is based on direct measurement of a biomarker concentration.

Therapeutic

No
The device is described as an in vitro diagnostic test for the quantitative measurement of carcinoembryonic antigen, used as an aid in the management of cancer patients. This indicates it is a diagnostic tool, not a device used for therapy or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that "The CEA method is an in vitro diagnostic test for the quantitative measurement of carcinoembryonic antigen in human serum and sodium or lithium heparinized plasma on the Dimension Vista System." It also mentions that "Measurements of carcinoembryonic antigen are used as an aid in the management of cancer patients," which directly relates to diagnostic purposes.

SaMD (Software as a Medical Device)

The device description clearly details physical components (reagent cartridge, beads, antibodies, calibrator) and a chemical reaction process, indicating it is a hardware-based in vitro diagnostic device, not software-only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The document explicitly states "The CEA method is an in vitro diagnostic test for the quantitative measurement of carcinoembryonic antigen in human serum and sodium or lithium heparinized plasma on the Dimension Vista System." This directly identifies it as an in vitro diagnostic test.
Device Description: The description details a method for analyzing a biological sample (human serum and plasma) outside of the body ("in vitro") to measure a specific analyte (carcinoembryonic antigen).
Calibration: The mention of a calibrator ("LOCI 5 Calibrator") is typical for quantitative IVD tests, as they require calibration to ensure accurate measurements.
Performance Studies: The inclusion of method comparison and precision studies are standard for demonstrating the performance and reliability of an IVD device.
Predicate Device: The identification of a predicate device (Beckman Access® CEA Reagents on the Access® Immunoassay System) with a K number (K031270) indicates that this device is being compared to a previously cleared IVD device.

All of these elements strongly support the classification of this device as an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For the calibration of the Carcinoembryonic Antigen (CEA) method on the Dimension Vista® System.

Product codes (comma separated list FDA assigned to the subject device)

DHX, JIX

Device Description

Dimension Vista® CEA Flex® reagent cartridge

The CEA method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI™ technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-CEA monoclonal antibody fragment. The first bead reagent (Chemibeads) is coated with an anti-CEA monoclonal antibody and contains 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-CEA-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Ulumination 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 CEA concentration in the sample.

Dimension Vista® LOCI 5 Calibrator

LOCI 5 CAL is a liquid, multi-analyte, bovine serum albumin based product containing CEA from human tissue culture.

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

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)

Method Comparison

Regression Statistics:
Comparative Method: ACCESS® CEA
Slope: 1.01
Intercept ng/mL [µg/L]: 9.01
Correlation Coefficient: 0.989
n: 141b (range of values 0.8 - 974 ng/mL [µg/L])

Comparative Method: ACCESS® CEA
Slope: 1.04
Intercept ng/mL [µg/L]: 0.44
Correlation Coefficient: 0.970
n: 46c (range of values 0.8 -17.1 ng/mL [ug/L])

CLSI/NCCLS EP9-A2 was used. The method used to fit the linear regression line was ordinary least squares.

Precision

Material: Liquichek™ Immunoassay Plus Control Level 1
Mean ng/mL[µg/L]: 2.1
Repeatability: 0.1 (2.9)%CV
Within-Lab: 0.1 (3.4)%CV

Material: Liquichek™ Immunoassay Plus Control Level 2
Mean ng/mL[µg/L]: 26.2
Repeatability: 0.6 (2.2)%CV
Within-Lab: 0.8 (2.9)%CV

Material: Serum pool 1
Mean ng/mL[µg/L]: 0.9
Repeatability: 0.02 (2.3)%CV
Within-Lab: 0.02 (2.6)%CV

Material: Serum pool 2
Mean ng/mL[µg/L]: 12.8
Repeatability: 0.3 (2.6)%CV
Within-Lab: 0.4 (3.1)%CV

Material: Serum pool 3
Mean ng/mL[µg/L]: 67.5
Repeatability: 1.3 (1.9)%CV
Within-Lab: 1.6 (2.4)%CV

Material: Serum pool 4
Mean ng/mL[µg/L]: 478.0
Repeatability: 6.2 (1.3)%CV
Within-Lab: 10.1 (2.1)%CV

Material: Serum pool 5
Mean ng/mL[µg/L]: 756.4
Repeatability: 13.6 (1.8)%CV
Within-Lab: 24.9 (3.3)%CV

Material: Plasma pool
Mean ng/mL[µg/L]: 239.7
Repeatability: 5.2 (2.2)%CV
Within-Lab: 8.6 (3.6)%CV

CLSI/NCCLS EP5-A2 was used. During each day of testing, two separate runs, with two test samples, for each test material, were analyzed for 20 days.

Conclusion

These studies demonstrate correlation and equivalent precision performance between the Beckman Access® CEA Reagents on the Access® Immunoassay System and the Dimension Vista® CEA assay.

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.

K031270

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

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.

Summary

510{k} Summary for Dimension Vista® CEA Flex® reagent cartridge Dimension® Vista LOCI 5 Calibrator

JUN 2 5 2008

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.

The assigned 510(k) number is: K071603

| 1. | Manufacturer's Name, Address, Telephone, and Contact Person, Date of
Preparation: | |
|----|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturer: | Siemens Healthcare Diagnostics
P.O. Box 6101
Newark, Delaware 19714 |
| | Contact Information: | Siemens Healthcare Diagnostics
P.O. Box 6101
Newark, Delaware 19714-6101
Attn: Kathleen Dray-Lyons
Tel: 781-826-4551
Fax: 781-826-2497 |
| | Preparation date: | June 2, 2008 |
| 2. | Device Name: | Dimension Vista® CEA Flex® reagent cartridge
Dimension Vista® LOCI 5 Calibrator |
| | Classification: | Class II; Class II |
| | Product Code: | DHX; JIX |
| | Panel: | Immunology (82) and Clinical Chemistry (75) |

Identification of the Legally Marketed Devices: 3.

Beckman Access® CEA Reagents on the Access® Immunoassay System - K031270

Device Descriptions: 4.

Dimension Vista® CEA Flex® reagent cartridge

Dimension Vista® LOCI 5 Calibrator

LOCI 5 CAL is a liquid, multi-analyte, bovine serum albumin based product containing CEA from human tissue culture.

5. Device Intended Uses:

Dimension Vista® CEA Flex® reagent cartridge:

Dimension Vista® LOCI 5 Calibrator:

For the calibration of the Carcinoembryonic Antigen (CEA) method on the Dimension Vista® System.

6. Medical device to which equivalence is claimed and comparison information:

The Dimension Vista® CEA Flex® reagent cartridge and Dimension Vista® LOCI 5 Calibrator are substantially equivalent to the Beckman Access® CEA Reagents on the Access Immunoassay System (K031270). The Dimension Vista CEA assay, like Beckman Access® CEA method is an in vitro diagnostic test for the quantitative measurement of CEA in human serum.

Similarities
Item	Device	Predicate
Intended Use	The CEA method is an in vitro
diagnostic test for the quantitative
measurement of carcinoembryonic
antigen in human serum and
sodium or lithium heparinized
plasma on the Dimension Vista®
System.
Measurements of carcinoembryonic
antigen are used as an aid in the
management of cancer patients in
whom changing CEA
concentrations have been
observed.	The Access CEA assay is a paramagnetic
particle, chemiluminescent immunoassay
for the quantitative determination of
Carcinoembryonic Antigen (CEA) levels in
human serum, using the Access
Immunoassay System. CEA measured by
the Access Immunoassay System is used
as an aid in the management of cancer
patients.
Measuring
Range	0.2- 1000.0 ng/mL	0.1- 1000.0 ng/mL
Measurement
method	Chemiluminescent:
homogenous, sandwich
chemiluminescent immunoassay
based on LOCI® technology.	Chemiluminescent:
paramagnetic particle, chemiluminescent
immunoassay

Differences
Item	Device	Predicate
Principles of
Procedure	The CEA method is a homogenous,
sandwich chemiluminescent
immunoassay based on LOCI®
technology. The LOCI® reagents
include two synthetic bead reagents
and a biotinylated anti-CEA
monoclonal antibody fragment. The
first bead reagent (Chemibeads) is
coated with an anti-CEA monoclonal
antibody and contains
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-CEA-
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 Access CEA assay is a two-site
immunoenzymatic "sandwich" assay
using two mouse monoclonal anti-CEA
antibodies (MAb) which react with
different epitopes of CEA. A sample is
added to a reaction vessel, along with the
first anti-CEA MAb-alkaline phosphatase
conjugate and the second anti-CEA MAb
bound to paramagnetic particles. The
incubation is followed by a magnetic
separation and washing. A
chemiluminescent substrate, Lumi-Phos*
530, is added to the reaction vessel and
light generated by the reaction is
measured with a luminometer. The light
production is proportional to the
concentration of CEA in the sample. The
amount of analyte in the sample is
determined by means of a stored, multi-
point calibrator curve.
Sample
Types	Serum and Plasma	Serum
Sample Size	2 uL	10 uL
Precision	Repeatability: 1.3 - 2.9 %CV
Within Lab:
2.1 - 3.6 %CV	Within Run: 3.01 – 3.97 %CV
Total:
3.80 - 4.51 %CV

7. Device Performance Characteristics:

Method Comparison

Regression Statisticsª

| Comparative
Method | Slope | Intercept
ng/mL [µg/L] | Correlation
Coefficient | n |
|-----------------------|-------|---------------------------|----------------------------|------|
| ACCESS® CEA | 1.01 | 9.01 | 0.989 | 141b |
| ACCESS® CEA | 1.04 | 0.44 | 0.970 | 46c |

ACCESS® Immunoassay System is a registered trademark of Beckman Coulter, Inc. a. CLSI/NCCLS EP9-A2 was used. The method used to fit the linear regression line was ordinary least squares.

b. The range of 141 values in the correlation study was 0.8 - 974 ng/mL [µg/L].

c. The range of 46 values in the correlation study was 0.8 -17.1 ng/mL [ug/L].

Precision
Material	Mean
ng/mL[µg/L]	Standard Deviation (%CV)
		Repeatability	Within-Lab
Liquichek™
Immunoassay Plus
Control
Level 1	2.1	0.1 (2.9)	0.1 (3.4)
Level 2	26.2	0.6 (2.2)	0.8 (2.9)
Serum pool 1	0.9	0.02 (2.3)	0.02 (2.6)
Serum pool 2	12.8	0.3 (2.6)	0.4 (3.1)
Serum pool 3	67.5	1.3 (1.9)	1.6 (2.4)
Serum pool 4	478.0	6.2 (1.3)	10.1 (2.1)
Serum pool 5	756.4	13.6 (1.8)	24.9 (3.3)
Plasma pool	239.7	5.2 (2.2)	8.6 (3.6)

CLSI/NCCLS EP5-A2 was used. During each day of testing, two separate runs, with two test samples, for each test material, were analyzed for 20 days.

8. Conclusion:

These studies demonstrate correlation and equivalent precision performance between the Beckman Access® CEA Reagents on the Access® Immunoassay System and the Dimension Vista® CEA assay.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes extending from its back, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 5 2008

Dade Behring, Inc. c/o Ms. Kathleen Dray-Lyons Manager, Regulatory Affairs and Compliance Glasgow Site P.O. Box 6101 Newark, DE 19714-6101

Re: K071603

Trade/Device Name: Dimension Vista® CEA Flex® reagent cartridge Dimension Vista® LOCI 5 Calibrator Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: DHX, JIX Dated: June 2, 2008 Reccived: June 3, 2008

Dear Ms. Dray-Lyons:

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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to

Pagc 2 -

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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation catitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ia m chan

Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Indications For Use Statement

510(k) Number (if known):

Device Name:

Dimension Vista® CEA Flex® reagent cartridge

Indications for Use:

The CEA method is an in vitro diagnostic test for the quantitative measurement of carcinoembryonic antigen in human serum and sodium or lithium heparin plasma on the Dimension Vista® System. Measurements of carcinoembryonic antigen are used as an aid in the management of cancer patients in whom changing CEA concentrations have been observed.

Prescription Use (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)

Maria M Chan
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K07160

000012

Indications For Use Statement

Device Name:

K071603

Dimension Vista® LOCI 5 Calibrator

Indications for Use:

For the calibration of the Carcinoembryonic Antigen (CEA) method on the Dimension Vista® System.

Prescription Use (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)

Mana M Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)_Ko71603

000046