VIDAS® CEA (S) is an automated quantitative test for use on the VIDAS instruments, for the quantitative measurement of Carcinoembryonic antigen (CEA) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CEA (S) assay is indicated as an aid in the monitoring of cancer patients in whom changing concentrations of CEA are observed.

Device Description

The assay principle combines a two-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. It is coated with anti-CEA monoclonal immunoglobulins (mouse). The other assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs).

After dilution, the sample is transferred into the well containing CEA antibody (conjugate) labeled with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and to the conjugate to form a sandwich. Unbound compounds are eliminated during the first washing step.

A second incubation step is then performed with alkaline phosphatase-labeled anti-CEA polyclonal antibodies (goat). The unbound conjugate is then eliminated during washing steps.

During the final detection step, the substrate (4-Methyl-umbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.

AI/ML Overview

The provided document describes the VIDAS® CEA (S) Assay, a medical device for measuring Carcinoembryonic antigen (CEA) in human serum, and compares its performance to a predicate device, the TOSOH ST AIA-PACK CEA. This is an In Vitro Diagnostic (IVD) device, not an AI or imaging device, so many of the requested fields (like number of experts, adjudication, MRMC studies, standalone algorithm performance, and training set information) are not applicable or typically reported for this type of device.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For IVD devices like the VIDAS® CEA (S) Assay, acceptance criteria are typically demonstrated through analytical and clinical performance studies that show equivalence to a legally marketed predicate device. The document uses the TOSOH ST AIA-PACK CEA as its predicate. The key performance metrics are analytical precision (intra-assay and inter-run) and method comparison (correlation with the predicate device).

Performance Metric	Acceptance Criteria (Implied by Predicate Performance / Equivalence)	Reported VIDAS® CEA (S) Assay Performance
Intra-Assay Precision (CV)	Predicate: < 4.3% (Sample 1), < 3.6% (Sample 2), < 4.0% (Sample 3), < 3.1% (Sample 4)	Pool C: 2.7 - 4.4%Pool B: 3.5 - 4.4%Pool A: 3.7 - 5.3%
Inter-Run Precision (CV)	Predicate: < 3.9% (Sample 1), < 3.3% (Sample 2), < 3.6% (Sample 3), < 3.2% (Sample 4)	Pool C: 0 - 1.3%Pool B: 0 - 1.6%Pool A: 0 - 1.0%
Limits of Detection	Predicate: 0.5 ng/mL	< 0.5 ng/mL
Method Comparison (Slope)	Implied acceptance range for substantial equivalence typically includes a slope close to 1.0. The 95% CI of the slope for the predicate device is not explicitly given, but clinical equivalence would expect the CI for the new device to include 1.0 or be very close to it. The predicate device's performance is not described in terms of a method comparison study in this document, but rather it serves as the benchmark against which the new device is compared. The acceptance criteria would be that the new device shows strong correlation with the predicate.	Slope = 0.9410 (95% confidence interval = 0.8238 to 1.0582)
Method Comparison (Intercept)	Implied acceptance range for substantial equivalence typically includes an intercept close to 0.0. The 95% CI of the intercept for the predicate device is not explicitly given. Clinical equivalence would expect the CI for the new device to include 0.0 or be very close to it.	Intercept = -1.2905 (95% confidence interval = -1.6812 to -0.8998)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Method Comparison (Clinical Comparison): 1,307 samples
Sample Size for Precision (Non-clinical):
- Intra-Assay/Inter-Run: 40 runs (across sites and lots) for the VIDAS device. The exact number of individual samples within these runs for precision is not specified, but typically involves replicate measurements of control pools.
Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a retrospective method comparison using collected patient samples, as it references "Number of patients = 1,307 samples."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This is an in vitro diagnostic assay that measures a biomarker concentration. "Ground truth" for such devices is established by reference methods or comparison to a predicate device, not by expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. This is an in vitro diagnostic assay. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation (e.g., radiology reads), not for laboratory measurements of biomarker concentrations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is an in vitro diagnostic assay and does not involve human readers interpreting cases or AI assistance in that context. Therefore, there is no effect size reported for human readers improving with or without AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in essence, the performance data presented (precision, limits of detection, and method comparison) represents the standalone performance of the VIDAS® CEA (S) assay system. The device is automated, and its output (CEA concentration) is directly generated by the instrument based on the ELFA technique. There is no human interpretation or intervention in the generation of the quantitative result itself.

7. Type of Ground Truth Used

The "ground truth" for the VIDAS® CEA (S) assay's performance is established by:

Analytical Standards: Traceability to reference standards (bioMérieux, Inc. standards and the CarcinoEmbryonic Antigen 1st International Reference Preparation, NIBSC code 73/601).
Predicate Device Comparison: The clinical comparison section uses the TOSOH ST AIA-PACK CEA as the reference method ("X = TOSOH ST AIA-Pack CEA; y = VIDAS® CEA (S)"). Therefore, the performance of the predicate device serves as the operational ground truth for validating the new device's accuracy and correlation.

8. Sample Size for the Training Set

No specific "training set" of patient samples is mentioned in the context of machine learning or AI. For IVD assays, "training" typically refers to the internal development and optimization of the assay's reagents and calibration curve, which is often done using characterized materials, calibrators, and internal validation samples rather than a distinct "training set" of patient data as understood in AI/ML. The document mentions "Master curve for each kit lot and each calibrator lot are traceable to reference standards..." which describes how the assay is calibrated.

9. How the Ground Truth for the Training Set Was Established

As explained above, there isn't a traditional "training set" with ground truth in the AI/ML sense. For the calibration and development of the assay, the "ground truth" would be established through:

Reference Standards: The use of internationally recognized reference preparations (e.g., NIBSC code 73/601) and internal bioMérieux reference standards. These standards have assigned CEA values, providing the "truth" against which calibrations are performed and validated.
Internal Validation: Through rigorous analytical studies to establish assay linearity, recovery, interference, and other performance characteristics during product development.

Summary

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

Koroici4

510(k) SUMMARY

VIDAS® CEA (S) Assay

OCT 0 9 2008

A. Submitter Information

Submitter's Name:Address:	bioMérieux, Inc.595 Anglum RoadHazelwood, MO 63042
Contact Person:	Sandra Perreand
Phone Number:	314-731-8594
Fax Number:	314-731-8689
Date of Preparation:	September 29, 2008
B. Device NameTrade Name:	VIDAS® CEA (S) Assay
Common Name:	Carcinoembryonic Antigen
Classification Name:	System, Test, Carcinoembryonic Antigen

C. Predicate Device Name

Trade Name:

Tosoh Medical, Inc. ST AIA Pack CEA Enzyme Immunoassay

D. Device Description

A second incubation step is then performed with alkaline phosphatase-labeled anti-CEA polyclonal antibodies (goat). The unbound conjugate is then eliminated during washing steps.

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

E. Intended Use

The VIDAS CEA (S) assay is VIDAS® CEA (S) is an automated quantitative test for use on the VIDAS instruments, for the quantitative measurement of Carcinoembryonic antigen (CEA) in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CEA (S) assay is indicated as an aid in the monitoring of cancer patients in whom changing concentrations of CEA are observed.

F. Technological Characteristics Summary

A general comparison of the similarities and differences of the VIDAS CEA (S) assay to the predicate device is presented in the table below.

Item	VIDAS® CEA (S) Assay	TOSOH ST AIA-PACK CEA(K023893)
General Comparison
Intended Use	VIDAS® CEA (S) is an automatedquantitative test for use on the VIDASinstruments, for the quantitativemeasurement of Carcinoembryonicantigen (CEA) in human serum usingthe ELFA technique (Enzyme LinkedFluorescent Assay). The VIDAS CEA(S) assay is indicated as an aid in themonitoring of cancer patients in whomchanging concentrations of CEA areobserved.	ST AIA-PACK CEA is designed forIN VITRO DIAGNOSTIC USEONLY for the quantitativemeasurement of CarcinoembryonicAntigen (CEA) in human serum toaid in the management of cancerpatients in whom changingconcentrations of CEA are observedon TOSOH AIA System analyzers.
Specimen	Serum	Serum
Analyte	Carcinoembryonic Antigen	Carcinoembryonic Antigen
Antibody	Goat polyclonal CEA antibody; mousemonoclonal CEA antibody	Two mouse monoclonal CEAantibodies
Assay Principle	Two antibody "sandwich" binding of CEA.One antibody is bound to a solid phase andthe second antibody is in liquid form and islabeled with fluorescent compound	Two antibody "sandwich" binding ofCEA. One antibody is bound to asolid phase and the second antibodyis in liquid form and is labeled withfluorescent compound
Automated	Yes	Yes
Assay Technique	Enzyme-linked fluorescent assay (ELFA)	Two-site immunoenzymometricassay
Sample Volume	200 µL	100 µL
Traceability/Standardization	Master curve for each kit lot and eachcalibrator lot are traceable to referencestandards established by bioMérieux, Inc.and the CarcinoEmbryonic Antigen 1stInternational Reference Preparationprovided by the National Institute ofBiological Standards and Controls (NIBSC)code 73/601 (1975)	Each calibrator lot are traceable toWHO 1st International ReferencePreparation (IRP) 73/601 (1975)
Measurement range	0.5 - 200 ng/mL	0.5 - 100 ng/mL

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

G. Performance Data

A summary of the non-clinical and clinical test results is presented in the table below.

Test	VIDAS® CEA (S) Assay	TOSOH ST AIA-PACK CEA(K023894)
Non-clinical (Analytical) Comparison
Intra-Assay Precision	n = 40 runs (across sites and lots)Pool C:Mean = 3.4 ng/mLCV range = 2.7 - 4.4%Pool B:Mean = 25 ng/mLCV range = 3.5 - 4.4%Pool A:Mean = 160 ng/mLCV range = 3.7 - 5.3%	n = 20 replicatesSample 1:Mean = 4.56 ng/mLCV = 4.3%Sample 2:Mean = 19.74 ng/mLCV = 3.6%Sample 3:Mean = 45.64 ng/mLCV = 4.0%Sample 4:Mean = 79.11 ng/mLCV = 3.1%
Inter-Run Precision	n = 40 runs (across sites and lots)Pool C:Mean = 3.4 ng/mLCV range = 0 - 1.3%Pool B:Mean = 25 ng/mLCV range = 0 - 1.6%Pool A:Mean = 160 ng/mLCV range = 0 - 1.0%	n = 20 runsSample 1:Mean = 5.26 ng/mLCV = 3.9%Sample 2:Mean = 22.81 ng/mLCV = 3.3%Sample 3:Mean = 50.17 ng/mLCV = 3.6%Sample 4:Mean = 91.52 ng/mLCV = 3.2%
Limits of Detection	< 0.5 ng/mL	0.5 ng/mL

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

Clinical Comparison
Item	VIDAS® CEA (S) Assay	TOSOH ST AIA-PACK CEA(K023893)
Reference Range	Non-smoker:Female ≤ 2.44 ng/mLMale ≤ 3.23 ng/mLSmoker:Female ≤ 3.53 ng/mLMale ≤ 6.44 ng/mL	Non-smoker: ≤ 3.07 ng/mLSmoker: ≤ 6.17 ng/mL
Method Comparison
Methods	X = TOSOH ST AIA-Pack CEA; y = VIDAS® CEA (S)
Number of patients	1,307 samples
Results	Slope = 0.9410 (95% confidence interval = 0.8238 to 1.0582)Intercept = -1.2905 (95% confidence interval = -1.6812 to -0.8998)

H. Conclusion

The VIDAS® CEA (S) Assay is substantially equivalent to the Tosoh Medical, Inc. ST AIA Pack CEA Assay.

The 510(k) summary includes only information that is also covered in the body of the 510(k). The summary does not contain any puffery or unsubstantiated labeling claims. The summary does not contain any raw data, i.e., contains only summary data. The summary does not contain any trade secret or confidential commercial information. The summary does not contain any patient identification information.

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

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 0 9 2008

bioMèricux, Inc. c/o Ms. Sandra Perreand Senior Director, North American Regulatory Affairs 595 Anglum Road Hazelwood, MO 63042

Re: K080194

Trade/Device Name: Vidas® CEA (S) Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor associated antigen immunological test systems Regulatory Class: Class II Product Code: DHX Dated: September 29, 2008 Received: September 30, 2008

Dear Ms. Perreand:

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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter

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

Page 2 - bioMèrieux, Inc.

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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.

ia m Chen

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

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

Indications for Use

510(k) Number (if known): K080194

, "i

Device Name: VIDAS® CEA (S)

Indications For Use:

Prescription Use × (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Reena Philip

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080194

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.