The ADVIA® Centaur (DHEAS) Master Curve Material are for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA Centaur® Systems Dehydroepiandrosterone sulfate (DHEAS) assay.

Device Description

The ADVIA® Centaur DHEAS Master Curve Material are 5 levels of varying concentrations of DHEAS in delipidated, steroid stripped, human defribrinated plasma with preservative. The MCM Master Curve Materials have expected values (lot specific) of 0, 60, 300, 900 and 1500 ug/dL.

The MCM Master Curve Material (1.0 mL/vial) are liquid and ready to use. Storage is at 2 - 8ºC.

AI/ML Overview

The provided text is a 510(k) summary for the ADVIA® Centaur DHEAS Master Curve Material. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics for the new device. Therefore, much of the requested information about device performance and study design (especially for AI/standalone studies, expert involvement, and ground truth establishment) cannot be extracted from this summary.

Here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state quantitative acceptance criteria for the ADVIA® Centaur DHEAS Master Curve Material. Instead, it asserts that the product's performance has been validated and is "substantially equivalent to currently marketed devices with similar intended uses."

Characteristic	Acceptance Criteria (Not Explicitly Stated as Quantitative Criteria)	Reported Device Performance
Traceability	Implied: Must be traceable to established standards.	Validated following Siemens Healthcare Diagnostics procedures.
Value Assignment	Implied: Values must be accurately assigned.	Validated following Siemens Healthcare Diagnostics procedures.
Stability	Implied: Must maintain performance over specified storage and open-vial duration.	Unopened: stable until expiration date. Opened: stable for 60 days.
Intended Use	Must verify calibration and reportable range for DHEAS assay on ADVIA® Centaur Systems.	"for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA® Centaur Systems DHEAS assay." (Statement of Intended Use)

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical or laboratory testing that would have a sample size for performance evaluation. The "Master Curve Material" itself is the product being evaluated, and its performance (traceability, value assignment, stability) was internally validated. The "5 levels of varying concentrations of DHEAS" are part of the product and its stated characteristics, not a test set for performance evaluation in the typical sense of a diagnostic device.

There is no mention of data provenance (e.g., country of origin, retrospective/prospective) for a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The DHEAS Master Curve Material is a quality control product, and its "ground truth" would be established through a process of value assignment against reference materials or methods, not typically by expert consensus in a clinical image or diagnostic context.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set requiring adjudication in this technical summary.

5. 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 a 510(k) for an in vitro diagnostic quality control material, not an AI-powered diagnostic device, so MRMC studies or AI involvement are outside the scope of this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

For the DHEAS Master Curve Material, the "ground truth" (i.e., the assigned values and verification of performance) is established through:

Reference Methods/Materials: The document states "The traceability, value assignment, and stability of the ADVIA® Centaur DHEAS Master Curve Materials have been validated following procedures of Siemens Healthcare Diagnostics." This implies that the assigned values for DHEAS concentration are derived from reference materials or methods within their internal validation processes.
Stated Concentrations: The MCM Master Curve Materials have expected values (lot-specific) of 0, 60, 300, 900, and 1500 ug/dL. These are the target "true" values for the material.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set mentioned.

Summary

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K091123

510(k) Summary

Submitter informationContact person:	Clare SantulliSr. Regulatory Technical Specialist
Address:	Siemens Healthcare Diagnostics511 Benedict AvenueTarrytown, NY 10591-5097		AUG 1 4 2009
Phone:	914-524-2701914-524-3579 (fax)
Date summary prepared:		June 11, 2009
Device Trade or Proprietary Name:		ADVIA® Centaur DHEAS Master CurveMaterial
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: K091123

Predicate Devices:

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

Siemens Healthcare Diagnostics ADVIA Centaur DHEAS Master Curve Materials Premarket Notification - Abbreviated 510(K) 510(k) Summary

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Device Description:

The MCM Master Curve Material (1.0 mL/vial) are liquid and ready to use. Storage is at 2 - 8ºC.

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 (HBsAg), 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 labor atory practices.

Statement of Intended Use:

The ADVIA® Centaur DHEAS Master Curve Material are for in vitro diagnostic use in the verification of calibration and reportable range in the ADVIA® Centaur Systems Dehydroepiandrosterone sulfate (DHEAS) assay.

Performance:

The traceability, value assignment, and stability of the ADVIA® Centaur DHEAS Master Curve Materials have been validated following procedures of Siemens Healthcare Diagnostics. These DHEAS 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:

Item	Device	Predicate
	ADVIA® DHEAS Master CurveMaterial	Maine Standards CompanyVALIDATE Thyroid CalibrationVerification Test Set(K062501)
Intended Use	The ADVIA® Centaur DHEASMaster Curve Material are for in vitro diagnostic use in theverification of calibration andreportable range in the ADVIACentaur® SystemsDehydroepiandrosteronesulfate (DHEAS) 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	Liquid	Liquid
Analytes	DHEAS only	Multiple analytes includingTriiodothyronine (Ta), Thyroxineff4), human Thyroid StimulatingHormone (TSH), and Cortisol
Storage	2°C to 8°C	-10°C to -20°C
Stability	Unopened - until expiration dateon the vial labelOpened - 60 days	Unopened - until expiration dateon storage container when storedas directed
Differences	Verification of calibration andreportable range for the ADVIACentaur® DHEAS assay.	Verification of calibration,linearity, and reportable range formultiple assays (Triiodothyronine(Ta), Thyroxine ff4), humanThyroid Stimulating Hormone(TSH), and Cortisol).
Matrix	Human Plasma	Human Serum

Comparison Table*

From Instructions for Use

Conclusions:

The ADVIA® Centaur DHEAS 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, matrix, and stability.

Siemens Healthcare Diagnostics ADVIA Centaur DHEAS Master Curve Materials Premarket Notification - Abbreviated 510(k) 510(k) Summary

Page 3 of 3

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an emblem that resembles a stylized caduceus, featuring a staff with a snake winding around it.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

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

AUG 1 4 2009

K091123 Re:

Trade/Device Name: ADVIA Centaur DHEAS Master Curve Materials Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I (Reserved) Product Code: JJX Dated: June 11, 2009 Received: June 16, 2009

Dear Clare 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 11 your as not 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 I toase of actived that I Drivination that your device complies with other requirements of the Act that + 21 there l 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 devicerelated 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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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 (301) 796-5450. Also, please note the regulation entitled, 'Misbranding by reference to premarket notification" (21 CFR 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 (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

G. C. H

Courtney C. Harper, Ph.D. Acting 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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Indications for Use

510(k) Number (if known): K091123

ADVIA CENTAUR® DHEAS Master Curve Material Device Name(s):

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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signature

Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510(k) K091123

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.