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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dimension Vista® CEA Flex® reagent cartridge and Dimension Vista® LOCI 5 Calibrator, based on the provided text:

Acceptance Criteria and Device Performance

The study demonstrates substantial equivalence to the predicate device, Beckman Access® CEA Reagents on the Access® Immunoassay System. The acceptance criteria are implicitly defined by showing comparable performance characteristics, particularly in method comparison (correlation) and precision.

Characteristic	Acceptance Criteria (Implicit, based on predicate)	Reported Device Performance (Dimension Vista® CEA Flex® reagent cartridge)
Method Comparison	Strong correlation with predicate device (e.g., correlation coefficient close to 1)	Correlation Coefficient: 0.989 (for 0.8-974 ng/mL range), 0.970 (for 0.8-17.1 ng/mL range) Slope: 1.01 (first study), 1.04 (second study) Intercept: 9.01 ng/mL (first study), 0.44 ng/mL (second study)
Precision	Comparable to predicate device: - Within Run: 3.01 – 3.97 %CV - Total: 3.80 - 4.51 %CV	Repeatability: 1.3 - 2.9 %CV Within-Lab: 2.1 - 3.6 %CV
Measuring Range	0.1 - 1000.0 ng/mL	0.2 - 1000.0 ng/mL

Study Details

Sample size used for the test set and the data provenance:
- Method Comparison:
  - 141 values for correlation study, range 0.8 - 974 ng/mL [µg/L].
  - 46 values for correlation study, range 0.8 - 17.1 ng/mL [ug/L].
- Precision:
  - Multiple test materials (Liquichek™ Immunoassay Plus Control Levels 1 & 2, Serum pools 1-5, Plasma pool) were analyzed. Specific sample numbers for each material are not explicitly stated, but the testing involved "two separate runs, with two test samples, for each test material, were analyzed for 20 days."
- Data Provenance: Not explicitly stated, but clinical laboratory studies are typically prospective. No country of origin is specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is an in vitro diagnostic device for quantitative measurement, and "ground truth" is established by the reference method (predicate device) and analytical precision. No human expert interpretation of results is part of this type of study for device performance.
Adjudication method for the test set: Not applicable. This is an analytical performance study, not a study involving human interpretation or adjudication.
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: Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, this is a standalone analytical performance study of the Dimension Vista® CEA Flex® reagent cartridge on the Dimension Vista® System. The performance metrics (correlation, precision) are for the assay system itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for method comparison was established by the predicate device (Beckman Access® CEA Reagents on the Access® Immunoassay System). For precision, standard reference materials and pooled samples were used as typical in analytical chemistry.
The sample size for the training set: Not applicable. This is not a machine learning or AI device that uses a "training set" in the conventional sense. The device is a chemical reagent and instrument system.
How the ground truth for the training set was established: Not applicable. (See #7).

Summary

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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 ofPreparation:
	Manufacturer:	Siemens Healthcare DiagnosticsP.O. Box 6101Newark, Delaware 19714
	Contact Information:	Siemens Healthcare DiagnosticsP.O. Box 6101Newark, Delaware 19714-6101Attn: Kathleen Dray-LyonsTel: 781-826-4551Fax: 781-826-2497
	Preparation date:	June 2, 2008
2.	Device Name:	Dimension Vista® CEA Flex® reagent cartridgeDimension 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

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.

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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 vitrodiagnostic test for the quantitativemeasurement of carcinoembryonicantigen in human serum andsodium or lithium heparinizedplasma on the Dimension Vista®System.Measurements of carcinoembryonicantigen are used as an aid in themanagement of cancer patients inwhom changing CEAconcentrations have beenobserved.	The Access CEA assay is a paramagneticparticle, chemiluminescent immunoassayfor the quantitative determination ofCarcinoembryonic Antigen (CEA) levels inhuman serum, using the AccessImmunoassay System. CEA measured bythe Access Immunoassay System is usedas an aid in the management of cancerpatients.
MeasuringRange	0.2- 1000.0 ng/mL	0.1- 1000.0 ng/mL
Measurementmethod	Chemiluminescent:homogenous, sandwichchemiluminescent immunoassaybased on LOCI® technology.	Chemiluminescent:paramagnetic particle, chemiluminescentimmunoassay

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Differences
Item	Device	Predicate
Principles ofProcedure	The CEA method is a homogenous,sandwich chemiluminescentimmunoassay based on LOCI®technology. The LOCI® reagentsinclude two synthetic bead reagentsand a biotinylated anti-CEAmonoclonal antibody fragment. Thefirst bead reagent (Chemibeads) iscoated with an anti-CEA monoclonalantibody and containschemiluminescent dye. The secondbead reagent (Sensibeads) iscoated with streptavidin andcontains a photosensitizer dye.Sample is incubated withbiotinylated antibody andChemibeads to form bead-CEA-biotinylated antibody sandwiches.Sensibeads are added and bind tothe biotin to form bead-pairimmunocomplexes. Illumination ofthe complex at 680 nm generatessinglet oxygen from Sensibeadswhich diffuses into the Chemibeads,triggering a chemiluminescentreaction.	The Access CEA assay is a two-siteimmunoenzymatic "sandwich" assayusing two mouse monoclonal anti-CEAantibodies (MAb) which react withdifferent epitopes of CEA. A sample isadded to a reaction vessel, along with thefirst anti-CEA MAb-alkaline phosphataseconjugate and the second anti-CEA MAbbound to paramagnetic particles. Theincubation is followed by a magneticseparation and washing. Achemiluminescent substrate, Lumi-Phos*530, is added to the reaction vessel andlight generated by the reaction ismeasured with a luminometer. The lightproduction is proportional to theconcentration of CEA in the sample. Theamount of analyte in the sample isdetermined by means of a stored, multi-point calibrator curve.
SampleTypes	Serum and Plasma	Serum
Sample Size	2 uL	10 uL
Precision	Repeatability: 1.3 - 2.9 %CVWithin Lab:2.1 - 3.6 %CV	Within Run: 3.01 – 3.97 %CVTotal:3.80 - 4.51 %CV

7. Device Performance Characteristics:

Method Comparison

Regression Statisticsª

ComparativeMethod	Slope	Interceptng/mL [µg/L]	CorrelationCoefficient	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].

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Precision
Material	Meanng/mL[µg/L]	Standard Deviation (%CV)
		Repeatability	Within-Lab
Liquichek™Immunoassay PlusControl
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.

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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

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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

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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

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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

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.