For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and plasma (EDTA and lithium heparin) and to aid in the management of patients with ovarian carcinoma using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum and plasma of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recommended that the ADVIA Centaur CA 125II assay be used under the order of a physician trained in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.

Device Description

The ADVIA Centaur CA 125II assay is comprised of the following reagents: CA 125II Lite Reagent (monoclonal mouse anti-M11 antibody labeled with acridinium ester and monoclonal mouse anti-OC 125 labeled with fluorescein in phosphate buffer with bovine serum albumin and preservatives) and CA 125II Solid Phase Reagent (monoclonal mouse anti-fluorescein antibody coupled to paramagnetic particles in phosphate buffer with bovine serum albumin and preservatives).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ADVIA Centaur CA 125II assay.

Acceptance Criteria and Device Performance for ADVIA Centaur CA 125II Assay

The Siemens Healthcare Diagnostics Inc. ADVIA Centaur CA 125II Assay is an in vitro diagnostic device for the quantitative, serial determination of CA 125 in human serum and plasma (EDTA and lithium heparin) to aid in the management of patients with ovarian carcinoma. The submission K200199 primarily focused on adding plasma as an accepted sample type.

Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit for predicate device or general industry standards)	Reported Device Performance (Candidate Device)
Detection Limits
Limit of Blank (LoB)	N/A (Previous Analytical Sensitivity: 2 U/mL)	2.0 U/mL
Limit of Detection (LoD)	N/A (Previously Not Applicable)	3.0 U/mL
Limit of Quantitation (LoQ)	N/A (Previously Not Applicable)	3.0 U/mL (within-laboratory CV ≤ 20%)
Measuring Interval	2 - 600 U/mL (Predicate Device)	3.0 – 600 U/mL
Method Comparison (vs. Bayer Immuno 1® CA 125II assay)	Strong correlation expected (e.g., r > 0.95)	Correlation coefficient (r) = 0.992
Equation (slope ideally close to 1, intercept close to 0)	N/A	ADVIA Centaur CA 125II = 1.025 (Bayer Immuno 1) + 1.15 U/mL
Specimen Equivalence (vs. Serum)	Slopes close to 1.0, intercepts close to 0, strong correlation (e.g., r close to 1.0)
Dipotassium EDTA plasma (y) vs. Serum (x)	N/A	Slope: 0.95 (0.92-0.98), Intercept: -0.4 U/mL (-1.5-0.7 U/mL), Correlation: 1.00
Lithium Heparin plasma (y) vs. Serum (x)	N/A	Slope: 1.03 (0.97-1.08), Intercept: -0.2 U/mL (-1.8-1.4 U/mL), Correlation: 1.00
Interferences (EDTA and Heparin)	Bias within an acceptable range (e.g., typically +/- 10% or +/- 20%)
Dipotassium EDTA (9.0 mg/mL)	N/A	3.7% bias (at 39.6 U/mL), 1.3% bias (at 526.5 U/mL)
Heparin (75 U/mL)	N/A	3.2% bias (at 42.4 U/mL), -0.9% bias (at 471.4 U/mL)

Study Details:

Sample size used for the test set and the data provenance:
- Method Comparison: 224 samples (range 3.1 to 466.6 U/mL). Data provenance is not explicitly stated (country, retrospective/prospective).
- Specimen Equivalence:
  - Dipotassium EDTA plasma vs. Serum: 162 sample pairs.
  - Lithium Heparin plasma vs. Serum: 119 sample pairs.
  - Data provenance is not explicitly stated (country, retrospective/prospective).
- Interferences: 2 tested analyte concentration levels for each substance (EDTA and Heparin) with "Analyte Concentration" values given. Sample size per level is not specified, but typically multiple replicates are used. Data provenance is not explicitly stated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is an in vitro diagnostic (IVD) assay for measuring CA 125 levels. The "ground truth" for this type of device is typically established by reference methods or predicate devices (as seen in the method comparison and specimen equivalence studies), not by expert consensus on image interpretation or clinical diagnosis. Therefore, this question is not directly applicable in the context of this IVD device. The validation relies on the quantitative measurement accuracy against established methods.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is an IVD assay measuring an analyte, not requiring human adjudication of results in the way image interpretation or clinical diagnosis would.
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 IVD laboratory assay, not an AI-powered diagnostic imaging or clinical decision support system involving human readers.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
Yes, the performance characteristics (detection limits, method comparison, specimen equivalence, interferences) represent the standalone performance of the ADVIA Centaur CA 125II assay. It's a fully automated immunoassay, so its performance is inherently "algorithm only" (the biochemical reaction and detection system). While results are used by clinicians, the measurement itself is standalone.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For method comparison, the "ground truth" was established by the Bayer Immuno 1® CA 125II assay, which served as the reference method. For specimen equivalence, human serum served as the reference matrix against which plasma samples were compared. For detection limits, it's based on statistical analysis of blank and low-concentration samples.
The sample size for the training set:
Not applicable in the AI sense. This is a traditional immunoassay, not a machine learning model that requires a "training set." The assay principle, design, and reagent formulation were established through standard laboratory development and validation processes, not machine learning training.
How the ground truth for the training set was established:
Not applicable for the reason stated above. The "ground truth" for developing and calibrating an immunoassay involves extensive analytical chemistry, antibody development, and optimization of reaction conditions, with reference to known standards and established methods, rather than a "training set" with established ground truth labels in the machine learning context.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study detailed in the 510(k) submission K200199 focused on demonstrating the substantial equivalence of the ADVIA Centaur CA 125II assay with the expanded sample type (EDTA and lithium heparin plasma) to its predicate device, which only accepted serum.

The key studies presented to support this included:

Detection Limit determination: Performed in accordance with CLSI Document EP17-A2, establishing LoB, LoD, and LoQ. These values were provided and indicate the analytical sensitivity of the assay.
Method Comparison: The assay's performance was compared against the Bayer Immuno 1® CA 125II assay using 224 samples. A strong correlation (r = 0.992) and a regression equation (ADVIA Centaur CA 125II = 1.025 (Bayer Immuno 1) + 1.15 U/mL) were reported, demonstrating agreement with a commonly used predicate.
Specimen Equivalence: This crucial study, performed in accordance with CLSI Document EP09-A3, compared results from EDTA plasma and lithium heparin plasma against serum samples. The reported slopes (0.95 for EDTA, 1.03 for lithium heparin) and intercepts (-0.4 U/mL for EDTA, -0.2 U/mL for lithium heparin) with corresponding 95% confidence intervals falling close to the ideal (slope=1, intercept=0) and high correlation coefficients (1.00 for both) indicate that plasma matrices yield comparable results to serum. This directly supports the safety and effectiveness of using plasma samples.
Interference testing: Performed per CLSI Document EP07-ed3, demonstrating that high concentrations of EDTA and Heparin do not significantly interfere with the assay's results (bias within low single digits).

The submission argues that "The assay principle, design and reagent formulation has not changed from the original device, therefore, the analytical performance studies and data previously reviewed under 510(K) K020828 continues to apply to this assay." The additional studies specifically addressed the change in sample type (plasma), showing that the device performs equivalently with these new sample types as it does with serum, thus meeting the requirements for substantial equivalence.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 6, 2020

Siemens Healthcare Diagnostics, Inc. Fatima Pacheco Regulatory Clinical Affairs Specialist 511 Benedict Ave. Tarrytown, New York 10591

Re: K200199

Trade/Device Name: ADVIA Centaur CA 125 II Assay Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-Associated Antigen Immunological Test System Regulatory Class: Class II Product Code: LTK Dated: January 24, 2020 Received: January 27, 2020

Dear Fatima Pacheco:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Carolina Kagan Acting Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K200199

Device Name ADVIA Centaur® CA 125II

Indications for Use (Describe)

For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and plasma (EDTA and lithium heparin) and to aid in the management of patients with ovarian carcinoma using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum and plasma of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recommended that the ADVIA Centaur CA 125I assay be used under the order of a physician trained in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/3/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.

510(k) Summary of Safety and Effectiveness for ADVIA Centaur® CA 12511

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.

A. 510(k) Number: K200199

B. Purpose for Submission:

Modified Device - addition of plasma sample type

C. Applicant:

Contact: Fatima Pacheco Regulatory Clinical Affairs Specialist
Address: Siemens Healthcare Diagnostics Inc. 511 Benedict Ave,

Tarrytown, NY 10591

(914) 374-3770 Phone:

Email: fatima.pacheco@siemens-healthineers.com
April 03, 2020 Date:
D. Proprietary and Established Names: ADVIA Centaur® CA 125II

E. Measurand

Cancer Antigen 125 (CA 125)

F. Requlatory Information:

Trade Name	ADVIA Centaur® CA 125II
Common Name	Chemiluminescence Immunoassay, for thedetermination of CA 125 antigen
Classification Name	Device to test, epithelial ovarian tumor-associatedantigen (ca125).
FDA Classification	Class II
Review Panel	Immunology (82)
Product Code	LTK
Regulation Number	21 CFR 866.6010

G. Predicate Devices:

Device Name: Bayer ADVIA Centaur CA 125II 510(k) Number: K020828

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

Image /page/4/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.

H. Intended Use:

Same as Indications for Use

-Indications for Use:

For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and plasma (EDTA and lithium heparin) and to aid in the management of patients with ovarian carcinoma using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum and plasma of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recommended that the ADVIA Centaur CA 125ll assay be used under the order of a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.

J. Special Conditions for use statement(s):

For Prescription Use Only

K. Special Instrument Requirement:

For use on the ADVIA Centaur® XP and ADVIA Centaur XPT

L. Device Description:

The ADVIA Centaur CA 125Il assay is comprised of the following reagents:

Component	Volume	Ingredients
CA 125II Lite Reagent	10.0 mL/pack	monoclonal mouse anti-M11 antibody(~0.15 µg/mL) labeled with acridinium ester andmonoclonal mouse anti-OC 125 (~1.0 µg/mL)labeled with fluorescein in phosphate buffer withbovine serum albumin and preservatives
CA 125II Solid PhaseReagent	25.0 mL/pack	monoclonal mouse anti-fluorescein antibody(~30 µg/mL) coupled to paramagnetic particles inphosphate buffer with bovine serum albumin andpreservatives

M. Substantial Equivalence Information

The following table demonstrates substantial equivalence between the ADVIA Centaur 125ll assay (Candidate Device) with modified Package Insert (Instructions for Use) with the addition of plasma sample type (EDTA & Lithium Heparin) and the currently marketed ADVIA Centaur CA 125II (Predicate Device) that was cleared under 510 (k) K020828.

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

Image /page/5/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

Trade Name	Candidate Device - Modified Labeling	Predicate Device - Current Labeling
	ADVIA Centaur® CA 125II	ADVIA Centaur® CA 12511
Intended Use	For in vitro diagnostic use in thequantitative, serial determinationof CA 125 in human serum andplasma (EDTA and lithiumheparin) and to aid in themanagement of patients withovarian carcinoma using theADVIA Centaur® XP, and ADVIACentaur® XPT systems. The testis intended for use as an aid inmonitoring patients previouslytreated for ovarian cancer. Serialtesting for CA 125 in the serumand plasma of patients who areclinically free of disease shouldbe used in conjunction with otherclinical methods used for theearly detection of cancerrecurrence. The test is alsointended for use as an aid in themanagement of ovarian cancerpatients with metastatic diseaseby monitoring the progression orregression of disease in responseto treatment. It is recommendedthat the ADVIA Centaur CA 12511assay be used under the order ofa physician trained andexperienced in the managementof gynecological cancers. Thisassay is not intended forscreening or diagnosis of ovariancancer or for use on any othersystem.	For in vitro diagnostic use in thequantitative, serialdetermination of CA 125 inhuman serum and to aid in themanagement of patients withovarian carcinoma using theADVIA Centaur®, ADVIACentaur XP, and ADVIACentaur XPT systems. The testis intended for use as an aid inmonitoring patients previouslytreated for ovarian cancer.Serial testing for CA 125 in theserum of patients who areclinically free of disease shouldbe used in conjunction withother clinical methods used forthe early detection of cancerrecurrence. The test is alsointended for use as an aid inthe management of ovariancancer patients with metastaticdisease by monitoring theprogression or regression ofdisease in response totreatment. It is recommendedthat the ADVIA Centaur CA125ll assay be used under theorder of a physician trained andexperienced in themanagement of gynecologicalcancers. This assay is notintended for screening ordiagnosis of ovarian cancer orfor use on any other system.
Analyte	Cancer Antigen 125 (CA 125)	Same
Automated	Automated assay	Same
Measurement	Quantitative	Same
Sample Type	Human Serum and Plasma(EDTA and Lithium Heparin)	Human Serum
Detection Limit	LoB: 2.0 U/mLLoD: 3.0 U/mLLoQ: 3.0 U/mL	Analytical Sensitivity: 2 U/mLNot ApplicableNot Applicable
Assay MeasuringInterval	3.0 – 600 U/mL	2 - 600 U/mL
Trade Name	Candidate Device - ModifiedLabeling	Predicate Device - CurrentLabeling
	ADVIA Centaur® CA 125II	ADVIA Centaur® CA 125II
Operating Principle	Sandwich	Sandwich
Technology	Direct Chemiluminescent	Same
Instrument	ADVIA Centaur Systems	Same
Sample Volume	50 µL	50 µL
Calibrators	ADVIA Centaur CA 125IICalibrator	Same
Controls	Commercial Controls	Same
Detection Antibody	monoclonal mouse anti-M11antibody (~0.15 µg/mL) labeledwith acridinium ester andmonoclonal mouse anti-OC 125(~1.0 µg/mL) labeled withfluorescein	Same
Capture Antibody	monoclonal mouse anti-fluorescein antibody (~30 µg/mL)coupled to paramagnetic particles	Same

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

Image /page/6/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

N. Test Principle

The ADVIA Centaur CA 125II assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses two monoclonal mouse antibodies specific for CA 125. The first antibody is directed toward the M11 antigenic domain, and is labeled with acridinium ester. The second antibody is directed toward the OC 125 antigenic domain and is labeled with fluorescein. The immunocomplex formed with CA 125 is captured with monoclonal mouse anti-fluorescein antibody coupled to paramagnetic particles in the Solid Phase.

A direct relationship exists between the amount of CA 125 present in the patient sample and the amount of relative light units (RLUs) detected by the system.

O. Performance Characteristics

The assay principle, design and reagent formulation has not changed from the original device, therefore, the analytical performance studies and data previously reviewed under 510(K) K020828 continues to apply to this assay.

Detection Limit .

Detection capability was determined in accordance with CLSI Document EP17-A2.

Limit of Blank (LoB)	2.0 U/mL
Limit of Detection (LoD)	3.0 U/mL
Limit of Quantitation (LoQ)	3.0 U/mL

The LoB corresponds to the highest measurement result that is likely to be observed for a blank sample with a probability of 95%.

The LoD corresponds to the lowest concentration of CA 125 that can be detected with a probability of 95%.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.

The LoQ corresponds to the lowest amount of CA 125 in a sample at which the within-laboratory CV is ≤ 20%.

II. Method Comparison

For 224 samples in the range of 3.1 to 466.6 U/mL, the relationship of the ADV/A Centaur CA 125Il assay to the Bayer Immuno 1® CA 125II assay is described by the following equation:

ADVIA Centaur CA 125II = 1.025 (Bayer Immuno 1) + 1.15 U/mL

Correlation coefficient (r) = 0.992

Specimen Equivalence lll.

The study was performed in accordance with CLSI Document EP09-A3 to demonstrate that EDTA and Li-heparin plasma matrices yield comparable results as serum with the ADVIA Centaur CA 125 II assay. A Deming linear regression analysis was performed, and the corresponding slopes of regression and coefficient determination are summarized in the following table:

Sample Type	N	SampleInterval	Slope(95% CI)	Intercept(95% CI)	Correlationcoefficient
Dipotassium EDTAplasma (y) vs.Serum (x)	162	3.0 – 572.7U/mL	0.95(0.92 - 0.98)	- 0.4 U/mL(-1.5 – 0.7 U/mL)	1.00
Lithium Heparinplasma (y) vs.Serum (x)	119	3.1 - 572.7U/mL	1.03(0.97 – 1.08)	- 0.2 U/mL(-1.8 – 1.4 U/mL)	1.00

IV. Interferences: EDTA and Heparin

Interference testing was performed in accordance with CLSI Document EP07-ed3. The following results were obtained:

Substance	Substance TestConcentration	AnalyteConcentration(U/mL)	Bias (%)
Dipotassium EDTA	9.0 mg/mL	39.6	3.7
		526.5	1.3
Heparin	75 U/mL	42.4	3.2
		471.4	-0.9

P. Proposed Labeling

The labeling supports the finding of substantial equivalence for this device.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

Q. Conclusion

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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.