Predicate Devices

Immuno 1

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro immunoassay for measuring CA 15-3 levels. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on analytical characteristics like imprecision and correlation, not algorithmic performance metrics.

Therapeutic

No
The device is an in vitro immunoassay intended for quantitative measurement of CA 15-3 values to monitor disease course and therapy, and detect recurrence; it does not provide therapy itself.

Diagnostic

Yes

This device is an in vitro immunoassay intended to quantitatively measure CA 15-3 values in human serum, which is used for monitoring the course of disease and therapy in metastatic breast cancer, and for the detection of recurrence, thus serving a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device is an in vitro immunoassay, which is a laboratory test that uses biological components and chemical reactions to measure substances in a sample. This inherently involves physical reagents and instrumentation, not just software.

IVD (In Vitro Diagnostic)

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

The "Intended Use / Indications for Use" section explicitly states: "This in vitro immunoassay is intended to quantitatively measure CA 15-3 values in human serum."

This clearly indicates that the device is designed to perform tests on biological samples (human serum) outside of the body ("in vitro") to provide diagnostic information.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This in vitro immunoassay is intended to quantitavely measure CA 15-3 values in When used in conjunction with other clinical and diagnostics human serum. procedures, serial testing using ADVIA IMS CA 15-3 Assay on a Bayer ADVIA® IMS ™, is indicated for monitoring the course of disease and therapy in metastatic breast cancer patients, and for the detection of recurrence in previously treated Stage II, with greater than two positive lymph nodes, or Stage III breast cancer patients.

The Bayer ADVIA® IMS™CA 15-3 Assay is an in vitro diagnostic device intended to quantitatively measure CA 15-3 Assay values in human serum. When used in conjunction with other clinical and diagnostic procedures, serial testing with CA 15-3 Assay results are useful in monitoring the course of disease and therapy in metastatic breast cancer patients, and for the detection of recurrence in previously treated Stage II, with greater than two positive lymph nodes, or Stage III breast cancer patients.

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

MOI, JIT

Device Description

Not Found

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)

A. Imprecision

ADVIA IMS
Level
(U/mL)	Total
CV (%)
12.3	4.7
29.6	5.5
59.1	5.3

Immuno 1
Level
(U/mL)	Total
CV(%)
13.5	4.0
33.2	3.3
102.3	3.4

B. Correlation (T-ADVIA IMS, X-Comparison system)

Specimen type	Comparison System (X)	N	Regression Equation	Syx (U/mL)	R	Sample Range (U/mL)
Serum	Immuno 1	73	$1.061 * X+1.50$	3.04	0.996	7.02-184.9

C. Interfering Substances

| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | CA 15-3 Conc.
(U/mL) | Effect
(% change) |
|---------------------------|-----------------------------------|-------------------------|----------------------|
| Hemoglobin | 1000 | 16.2 | 1.1 |
| Lipids
(Triglycerides) | 1000 | 27.4 | 2.5 |
| Bilirubin | 25 | 35.5 | 0.1 |
| IgG | 6000 | 31.5 | 2.3 |
| Albumin | 6000 | 28.0 | 4.6 |

Analytical Range : 0.04 - 200 U/mL

Conclusion: Performance of the ADVIA IMS CA 15-3 Assay on a Bayer ADVIA® IMS ™ is equivalent to the performance of the CA 15-3 Assay on the predicate device (Immuno 1) and is within proposed specifications. No safety and effectiveness issues have been raised.

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.

Immuno 1

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

0

NOV 12 2002

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS CA 15-3 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: (leave blank)

1. Intended Use

This in vitro immunoassay is intended to quantitavely measure CA 15-3 values in When used in conjunction with other clinical and diagnostics human serum. procedures, serial testing using ADVIA IMS CA 15-3 Assay on a Bayer ADVIA® IMS ™, is indicated for monitoring the course of disease and therapy in metastatic breast cancer patients, and for the detection of recurrence in previously treated Stage II, with greater than two positive lymph nodes, or Stage III breast cancer patients.

Predicate Device 2.

Product Name	Reagent Part #	Calibrator Part #
Immuno 1 CA 15-3	T01-3553-51	T03-3554-01

3. Device / Method

| Product Name | Reagent Part # /
BAN # | Calibrator Part # /
BAN # |
|----------------------------|---------------------------|------------------------------|
| ADVIA IMS CA 15-3
Assay | B42-3894-41 /
08623765 | B43-3926-01 /
05523158 |

A. Imprecision

ADVIA IMS
Level
(U/mL)	Total
CV (%)
12.3	4.7
29.6	5.5
59.1	5.3

Immuno 1
Level
(U/mL)	Total
CV(%)
13.5	4.0
33.2	3.3
102.3	3.4

1

B. Correlation (T-ADVIA IMS, X-Comparison system)
Specimen type	Comparison System (X)	N	Regression Equation	Syx (U/mL)	R	Sample Range (U/mL)
Serum	Immuno 1	73	$1.061 * X+1.50$	3.04	0.996	7.02-184.9

B. Correlation (Y=ADVIA IMS. X=Comparison system)

C. Interfering Substances

| Interfering
Substance | Interfering Sub.
Conc. (mg/dL) | CA 15-3 Conc.
(U/mL) | Effect
(% change) |
|---------------------------|-----------------------------------|-------------------------|----------------------|
| Hemoglobin | 1000 | 16.2 | 1.1 |
| Lipids
(Triglycerides) | 1000 | 27.4 | 2.5 |
| Bilirubin | 25 | 35.5 | 0.1 |
| IgG | 6000 | 31.5 | 2.3 |
| Albumin | 6000 | 28.0 | 4.6 |

Analytical Range : 0.04 - 200 U/mL

Minimum Detectable Concentration

A TREFF .	/TT'
TMC /TIl-	mminn
C
C
1

| C
11.00
Section of the consisted to the considered to the contrôleant of the comments of the comments of the comments of the comments of the comments of the comments of the comments | |

Conclusion 4.

Performance of the ADVIA IMS CA 15-3 Assay on a a Bayer ADVIA® IMS ™ is equivalent to the performance of the CA 15-3 Assay on the predicate device (Immuno 1) and is within proposed specifications. No safety and effectiveness issues have been raised.

Hume OPJ Taks

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

7/01/02

Date

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 2 2002

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

Re: K022178

Trade/Device Name: CA15-3 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: MOI, JIT Dated: October 25, 2002 Received: October 29, 2002

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

3

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 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 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance 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 Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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

4

Page 1 of 1

K022178 510(k) Number:

Device Name: CA15-3 Assay for the ADVIA® IMS™

Indications for Use:

The Bayer ADVIA® IMS™CA 15-3 Assay is an in vitro diagnostic device intended to quantitatively measure CA 15-3 Assay values in human serum. When used in conjunction with other clinical and diagnostic procedures, serial testing with CA 15-3 Assay results are useful in monitoring the course of disease and therapy in metastatic breast cancer patients, and for the detection of recurrence in previously treated Stage II, with greater than two positive lymph nodes, or Stage III breast cancer patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	J.P. Reeves
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K022178

Prescription Use
CounterUse
(Per 21 CFR 801.109)	OR Over-The-

(Optional Format 1-2-96)