This in vitro immunoassay is intended to quantitatively measure CEA in human serum using ADVIA IMS CEA Assay on a Bayer ADVIA® IMS™. Carcinoembryonic Antigen (CEA) is a protein polysaccharide normally present at very low concentrations in the blood of healthy adults. Colorectal cancer and a variety of neonlantic and other disease processes cause significant elevation of CEA, thus issued as a tumor marker. CEA assay is designed to aid in the management and prognosis of cancer patients in whom changing concentrations of CEA are observed.

The Bayer ADVIA® IMS™ CEA assay is an in vitro diagnostic device intended to qualitatively measure carcinoembryonic antigen (CEA) in human serum. CEA test results are to be used as an aid in the management of cancer patients by monitoring CEA concentrations. CEA testing is not recommended as a screening procedure to detect cancer in the general population.

Device Description

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AI/ML Overview

Here's an analysis of the acceptance criteria and study details based on the provided text, formatted to address your specific points:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance (ADVIA IMS CEA Assay)
Imprecision (Total CV%)	Level 2.05 ng/mL: 3.0%
	Level 10.76 ng/mL: 2.2%
	Level 16.85 ng/mL: 1.8%
Correlation (R value)	0.998
Correlation (Syx)	1.019 ng/mL
Interference (Hemoglobin)	0.4% change at 1000 mg/dL concentration
Interference (Lipids)	1.8% change at 1000 mg/dL concentration
Interference (Bilirubin)	1.2% change at 25 mg/dL concentration
Interference (IgG)	1.2% change at 6.0 mg/dL concentration
Interference (Albumin)	2.5% change at 6.5 mg/dL concentration
Analytical Range	0.2 – 100 ng/mL
Minimum Detectable Conc.	0.2 ng/mL

The acceptance criteria are implicitly defined by the performance of the predicate device (Immuno 1) which the ADVIA IMS CEA Assay aims to be substantially equivalent to. The provided table directly compares the performance of the ADVIA IMS to the Immuno 1 for imprecision and minimum detectable concentration. For other metrics like correlation and interference, specific thresholds are not explicitly stated, but the reported values demonstrate acceptable performance relative to the predicate device and expected analytical specifications for such assays, leading to the conclusion of substantial equivalence.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 89 serum specimens were used for the correlation study.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document indicates "human serum" samples were used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is an in vitro diagnostic (IVD) assay for quantitative measurement of a biomarker. The "ground truth" for such assays is established through comparison to a well-characterized reference method or predicate device. Human experts are generally not involved in establishing the ground truth for an IVD's quantitative measurements in the same way they would be for image interpretation.
Adjudication method for the test set:
- Not applicable. As this is a quantitative measurement compared to a predicate device, adjudication by multiple human readers is not relevant.
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 (IVD) device, not an AI-assisted diagnostic tool for image interpretation or similar applications where MRMC studies are typically conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance data presented (imprecision, correlation, interference, analytical range, minimum detectable concentration) represent the standalone performance of the ADVIA IMS CEA Assay device itself. It's a fully automated analytical system once the sample is loaded.
The type of ground truth used:
- Predicate Device Comparison: The primary "ground truth" or reference for establishing the performance of the ADVIA IMS CEA Assay was the Immuno 1 CEA Assay. The study demonstrates correlation and comparative performance against this legally marketed predicate device.
The sample size for the training set:
- Not specified. For an in vitro diagnostic assay, there isn't typically a "training set" in the machine learning sense. Assay development involves optimizing reagents, protocols, and instrument parameters, but not usually in a data-driven training paradigm like AI. The reported data pertains to the validation of the final developed assay.
How the ground truth for the training set was established:
- Not applicable, as there isn't a "training set" in the context of an IVD assay's analytical performance validation. The performance characteristics are inherent to the assay's chemical and instrumental design.

Summary

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DEC 21 2001

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CEA Assay for Bayer ADVIA® Integrated Modular System (IMS)™

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: 4013568

1. Intended Use

2. Predicate Device

T T P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P P PProduct Name		Reagent Part # Calibrator Part #	K #
Immuno 1 CEA Assay	T01-3184-51 T03-3188-01		P940030; down classified to
			210(k)

3. Device / Method

Product Name	Reagent Part # / BAN Number	Calibrator Part # / BAN Number
ADVIA IMS CEA Assay	B42-3897-42 /00610885 (100 tests)01075029 (250 tests)	B43-3929-01 /02918372

Imprecision

ADVIA IMS	Immuno 1
Level(ng/mL)	Total CV(%)	Level(ng/mL)	Total CV(%)
2.05	3.0	2	5.3
10.76	2.2	12	4.3
16.85	1.8	24	4.3

Correlation (Y= ADVIA IMS, X=comparison system)

Specimen type	Comparison System (X)	N	Regression Equation	Syx (ng/mL)	R	Sample Range (ng/mL)
Serum	Immuno 1	89	$0.973 * X + 0.093$	1.019	0.998	0.51-76.25

Interfering Substances

InterferingSubstance	Interfering SubstanceConcentrationmg/dL	CEAConcentration(ng/mL)	Effect(% change)
Hemoglobin	1000	2.01	0.4
Lipids (Triglycerides)	1000	1.6	1.8
Bilirubin	25	2.11	1.2
IgG	6.0	1.85	1.2
Albumin	6.5	1.71	2.5

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Analytical Range

0.2 – 100 ng/mL

Minimum Detectable Concentration

ADVIA IMS(ng/mL)	Immuno 1(ng/mL)
0.2	0.2

4. Conclusion

Performance of the ADVIA IMS CEA Assay on the prodicate device (Immuno 1) and is within proposed
performance of the CEA Assay on the prodicate device (Immuno 1) and is within performance of the OEFF Prosey one effectiveness issues have been raised.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 1 2001

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

K013568 Re:

Trade/Device Name: Carcenoembroyonic Antigen Assay for the Advia IMS Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: DHX Dated: October 24, 2001 Received: October 26, 2001

Dear Dr. Edds:

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. Iisting 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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nothication. The PDA Inding of bacalantan sour 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 and 1 If you desire specific acvice for your do vices), please contact the Office of Compliance at additionally 807.10 for m vide diaglions on the promotion and advertising of your device, (301) 594-4566. Tructionally for use at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionate assistance at its toll-free number (800) 638-2041 or Manufacturers International and Sells ss "http://www.fda.gov/odrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K0135 & 510(k) Number:

Device Name: Carcenoembroyonic Antigen Assay for the Advia IMS

Indications for Use:

The Bayer ADVIA® IMS™ CEA assay is an in vitro diagnostic device intended to The Buyer ADP In THE - SEPT abonny in antigen (CEA) in human serum. CEA test results qualitiatively incasure caremotified by monitoring CEA concentrations. CEA testing is ald in the management or cancedure to detect cancer in the general population.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number_17

Prescription Use (Per 21 CFR 801.109)

Over-The-CounterUse_

(Optional Format 1-2-96)

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.