The ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Enhanced Estradiol (eE2) assay.

Device Description

The ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material, Level 1 is buffer with bovine serum albumin and preservatives. Levels 2-6 are various levels of USP-Grade estradiol in Ivophilized normal male serum with sodium azide (0.1% after reconstitution) and preservatives.

The eE2 Master Curve Materials have expected values (lot specific) of 0, 60, 175, 450, 1500 and 2700 pg/mL.

The eE2 Master Curve Material (1.0 mL/vial) are Ivophilized material and stored at 2 -8°C.

AI/ML Overview

This is a 510(k) summary for a calibration verification material, not a medical device in the typical sense of diagnosing or treating a disease. Therefore, many of the typical acceptance criteria and study elements listed in your request (like "human readers improve with AI vs without AI assistance," "standalone performance," "number of experts," etc.) are not applicable here.

The "device" in this context is the ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material, which is a quality control material used to verify the calibration and reportable range of a diagnostic assay (the ADVIA Centaur® Enhanced Estradiol (eE2) assay).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a calibration verification material, the "acceptance criteria" and "performance" are primarily related to its ability to accurately verify the assay's calibration and range. The document states:

Acceptance Criteria (Implied)	Reported Device Performance
Traceability: Values traceable to a recognized standard.	"The traceability... have been validated following procedures of Siemens Healthcare Diagnostics." (Implies successful validation, though the specific standard is not mentioned).
Value Assignment: Accurate and reliable assignment of target values for each level.	"The value assignment... have been validated following procedures of Siemens Healthcare Diagnostics." (Implies successful validation. Expected values are given as lot-specific ranges: 0, 60, 175, 450, 1500 and 2700 pg/mL for Levels 1-6).
Stability: Maintain assigned values over time under specified storage/reconstitution conditions.	"The stability... have been validated following procedures of Siemens Healthcare Diagnostics."Unopened: "until expiration date on the vial label" (stored at 2°C to 8°C).Reconstituted: "14 days"On-board: "6 hours"
Substantial Equivalence: Similar in intended use and matrix to a predicate device.	"These Enhanced Estradiol Master Curve Material are substantially equivalent to currently marketed devices with similar intended uses." Specifically found substantially equivalent to Maine Standards Company, VALIDATE Thyroid Calibration Verification Test Set (K062501) in intended use and matrix.

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

Test Set Sample Size: The document does not specify a sample size for a 'test set' in the context of typical clinical performance studies. The evaluation is focused on the characteristics of the material itself (traceability, value assignment, stability) and its equivalence to a predicate device.
Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The studies performed were internal validation studies by Siemens Healthcare Diagnostics. The material itself contains human source material (normal male serum), but this refers to the composition of the material, not the provenance of clinical data.

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

Not Applicable. This type of device does not involve expert interpretation of images or clinical data to establish ground truth. The "ground truth" for this device relates to the assigned values of estradiol, which are established through a rigorous calibration and validation process by the manufacturer, typically traceable to reference methods or materials, not by expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not Applicable. There is no adjudication method in the traditional sense, as there are no clinical cases or disagreements among interpreters to resolve.

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

No. An MRMC study is not relevant for a calibration verification material. This device does not involve human readers interpreting clinical cases with or without AI assistance.

6. Standalone Performance Study

Yes, implicitly. The document describes the "Performance" of the device in terms of its traceability, value assignment, and stability, all of which are assessed independently of human interpretation of clinical data. This is the standalone performance of the material. However, it's not "algorithm-only" performance as there is no algorithm or AI involved. It's the performance of the chemical reference material itself.

7. Type of Ground Truth Used

Assigned Values / Reference Method Traceability. The "ground truth" for this device is the assigned estradiol concentrations for each of the six levels (0, 60, 175, 450, 1500, 2700 pg/mL). These values are established through the manufacturer's value assignment procedures, which typically involve measuring against a higher-order reference method or certified reference material to ensure traceability and accuracy.

8. Sample Size for the Training Set

Not Applicable / Not provided. This is not a machine learning or AI algorithm, so there is no "training set." The material's formulation and assigned values are determined through chemical and analytical validation, not statistical learning from a dataset.

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

Not Applicable. There is no training set for this type of device. The ground truth (assigned values for estradiol) for the material itself is established through the manufacturer's validated procedures, likely involving extensive analytical testing and comparison to reference standards.

Summary

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K102904

510(k) Summary

Submitter informationContact person:	Clare SantulliSr. Regulatory Technical Specialist	NOV 2 3 2010
Address:	Siemens Healthcare Diagnostics, Inc511 Benedict AvenueTarrytown, NY 10591
Phone:	914-524-2701914-524-3579 (fax)
Date summary prepared:	September 29, 2010
Device Trade or Proprietary Name:	ADVIA Centaur® Enhanced Estradiol (eE2)Master Curve Material
Device Common/Usual Name orClassification Name:	Single (Specified) Analyte Controls (Assayed AndUnassayed)
Classification Number/Class:	JJX / Class I
Classification Panel:	Clinical Chemistry (75)

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: ________________________________________

Predicate Devices:

Device Name	VALIDATE Thyroid Calibration Verification Test Set
Common name	VALIDATE THY Calibration Verification Test Set
510(k) Number	K062501
Manufacturer	Maine Standards Company

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Device Description:

The eE2 Master Curve Materials have expected values (lot specific) of 0, 60, 175, 450, 1500 and 2700 pg/mL.

The eE2 Master Curve Material (1.0 mL/vial) are Ivophilized material and stored at 2 -8°C.

CAUTION! POTENTIAL BIOHAZARD: Contains human source material. While each human serum or plasma donor unit used in the manufacture of this product was tested by FDAapproved methods and found nonreactive for hepatitis B surface antigen (HBsAq), antibody to hepatitis C (HCV), and antibody to HIV-1/2, all products manufactured using human source material should be handled as potentially infectious. Because no test method can offer complete assurance that hepatitis B or C viruses, HIV, or other infectious agents are absent, these products should be handled according to established good laboratory practices.

Statement of Intended Use:

The ADVIA Centaur® Enhanced Estradiol Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Enhanced Estradiol (eE2) assay,

Performance:

The traceability, value assignment, and stability of the ADVIA Centaur® Enhanced Estradiol Master Curve Materials have been validated following procedures of Siemens Healthcare Diagnostics. These Enhanced Estradiol Master Curve Material are substantially equivalent to currently marketed devices with similar intended uses.

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Comparison to the Predicate Device:

Similarities and Differences between the devices and the predicate are shown below:

Comparison Table*

	Device	Predicate
Item	ADVIA Centaur® Master CurveMaterial	Maine Standards CompanyVALIDATE Thyroid CalibrationVerification Test Set(K062501)
Intended Use	The ADVIA Centaur® EnhancedEstradiol Master Curve Materialis for in vitro diagnostic use inthe verification of calibration andreportable range in the ADVIACentaur® Enhanced Estradiol(eE2) assay.	The VALIDATE ThyroidCalibration Verification Test Setsolutions are for in vitrodiagnostic use in the quantitativedetermination of linearity,calibration verification andverification of reportable range inautomated, semi-automated andmanual chemistry systems.
Form	Lyophilized	Liquid
Analytes	Enhanced Estradiol only	Multiple analytes includingTriiodothyronine (Ta), Thyroxineff4), human Thyroid StimulatingHormone (TSH), and Cortisol
Matrix	Human Serum	Human Serum
Storage	2°C to 8°C	-10°C to -20°C
Stability	Unopened - until expiration dateon the vial labelReconstituted - 14 daysorOn-board - 6 hours	Unopened - until expiration dateon storage container when storedas directed
Differences	Verification of calibration andreportable range for the ADVIACentaur® Enhanced Estradiolassay.	Verification of calibration,linearity, and reportable range formultiple assays (Triiodothyronine(Ta), Thyroxine ff4), humanThyroid Stimulating Hormone(TSH), and Cortisol)

From Instructions for Use

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Conclusions:

The ADVIA Centaur® Enhanced Estradiol Master Curve Material is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Maine Standards Company, VALIDATE Thyroid Calibration Verification Test Set (K062501) in intended use and matrix.

Siemens Healthcare Diagnostics, Inc ADVIA Centaur eE2 Master Curve Materials Premarket Notification - Abbreviated 510(k) September 2010

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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 features a stylized eagle with outstretched wings, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is simple and monochromatic.

Public Health Service

Siemens Healthcare Diagnostics c/o Clare Santulli 511 Benedict Avenue Tarrytown. NY 10591 USA

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Re: K102904

Trade Name: ADVIA Centaur Enhanced Estradiol (eE2) Master Curve Material Regulation Number: 21 CFR 862.1660. Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, Reserved Product Codes: JJX NOV 2 3 2010 Dated: November 5, 2010 Received: November 8, 2010

Dear Ms. Santulli:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

G.C.

Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

NOV 2 3 2010

510(k) Number (if known) K 1029DY

Device Name: ADVIA Centaur® Enhanced Estradiol (eE2) Master Curve Material

Indication For Use:

Prescription Use _ V (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)

Division Sign Off

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

510(k) K102904

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.