PROG CAL is a single analyte, liquid, frozen, product containing progesterone and preservatives in a human serum base, for in vitro diagnostic use. Contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2), as well as for Hepatitis B surface Antigen and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive). Because no testing can offer complete assurance that these or other infectious agents are absent, this material should be handled using good laboratory practice to avoid skin contact and ingestion. The kit consists of ten vials, two each of five levels containing 1 mL per vial.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device (Siemens Healthcare Diagnostics Dimension Vista® Progesterone Calibrator) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found in clinical performance studies. The document primarily details the device's technical specifications, intended use, and a comparison to a similar, already-marketed device for the purpose of regulatory clearance.

Therefore, many of the requested details, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, are not applicable or not mentioned in this regulatory submission for a calibrator.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format for device performance in the way a clinical study would. The primary "performance" discussed relates to stability and value assignment, which are confirmed to meet "defined acceptance criteria" without specifying the exact criteria or the numerical results of those criteria in detail.

Acceptance Criteria Category	Reported Device Performance
Stability (Frozen: -15C to -25C)	Real-time calibrator shelf life determined by comparing results of calibrator levels stored at -15C and -25C with control calibrators stored at -70C. Recovery versus time monitored, and percent change over time determined. "Defined acceptance criteria were met at all conditions."
Stability (Opened/Thawed: 2-8°C)	Real-time testing after thawing at 2-8°C for 15 days. "Defined acceptance criteria were met at all conditions." Assigned values are stable for 15 days when recapped immediately and stored at 2-8°C. Assigned values are stable for 15 days when stored on board the Dimension Vista System after vial puncture.
Value Assignment	Values for each level of calibrator assigned using multiple Dimension Vista instruments and multiple reagent lots. Traceable to the Progesterone reference method (ID/GC/MS). The bottle value for each level is the mean of 45 replicates. "Defined acceptance criteria were met at all conditions."

2. Sample Size for Test Set and Data Provenance:

Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of clinical performance. For value assignment, "45 replicates" were used for each calibrator level to determine the mean bottle value. For stability, multiple calibrator levels were tested over time.
Data Provenance: Not specified. Likely internal laboratory data from Siemens Healthcare Diagnostics. Given it's a calibrator, the "data" would be analytical measurements rather than patient data.
Retrospective/Prospective: Not explicitly stated. Stability studies generally imply a prospective monitoring over time.

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

Not applicable in the context of calibrator performance. Ground truth for progesterone concentration is established through a reference method (ID/GC/MS), not expert consensus.

4. Adjudication Method for the Test Set:

Not applicable. The ground truth is based on an analytical reference method (ID/GC/MS) rather than subjective interpretation requiring adjudication.

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

No. This is a calibrator, not an AI-assisted diagnostic device that would involve human readers interpreting images or results. Therefore, an MRMC study is not relevant.

6. Standalone Performance Study:

Yes, indirectly. The stability testing and value assignment studies describe the performance of the calibrator itself (algorithm/device only in this context) to ensure it performs as expected over time and accurately assigns progesterone values. These studies confirm its analytical performance in a standalone capacity.

7. Type of Ground Truth Used:

Reference Method Traceability: The "ground truth" for the progesterone concentrations in the calibrator levels is established through traceability to the Isotope Dilution Gas Chromatography Mass Spectrometry (ID/GC/MS) reference measurement procedure.

8. Sample Size for the Training Set:

Not applicable. This is a calibrator, not a machine learning algorithm that requires a "training set" in the conventional sense. Its values are assigned based on measurements, not learning from data.

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

Not applicable, as there is no "training set" for a calibrator. The accuracy of the calibrator's assigned values is rooted in its traceability to the ID/GC/MS reference method.

Summary

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Siemens Healthcare Diagnostics Dimension Vista® Progesterone Calibrator

APR 0 5 2013

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
  Manufacturer:

Siemens Healthcare Diagnostics Inc. 500 GBC Dr., M/S 514 P.O. Box 6101 Newark, DE 19714

Contact Information:

Siemens Healthcare Diagnostics Inc. 500 GBC Dr., M/S 514 P.O. Box 6101 Newark, DE 19714 Attn: Anna Marie Kathleen Ennis Tel: 302-631-9352 FAX # 302-631-6299

Date of Preparation:

April 5, 2013

Device Name Proprietary Name

. Dimension Vista® Progesterone Calibrator (PROG CAL)

Common Name

Calibrator �

FDA Classification

Calibrator, Secondary ●
Class II .
Code JIT .
21CFR§862.1150 .

3. Identification of the Predicate Device

. Siemens Healthcare Diagnostics Dimension Vista® LOCl 9 Calibrator - K113373
Calibrator Secondary .
Class II .
. Code JIT
21CFR§862.1150 .

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Siemens Healthcare Diagnostics Dimension Vista® Progesterone Calibrator K#130698

FDA Guidance Document(s): 4.

"Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators ", . February 22, 1999.
"Refuse to Accept Policy for 510(k)s", December 31, 2012. .
"eCopy Program for Medical Device Submissions", December 31, 2012 .

5. Device Description(s):

Calibrator

PROG CAL is a single analyte, liquid, frozen, product containing progesterone and preservatives in a human serum base, for in vitro diagnostic use.

Contains human source material. Each donor unit used in the preparation of this product was tested by FDA-approved methods for the presence of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2), as well as for Hepatitis B surface Antigen and antibody to Hepatitis C Virus (HCV), and found to be negative (not repeatedly reactive). Because no testing can offer complete assurance that these or other infectious agents are absent, this material should be handled using good laboratory practice to avoid skin contact and ingestion.

The kit consists of ten vials, two each of five levels containing 1 mL per vial.

The shelf life for Dimension Vista™ Progesterone Calibrator (PROG CAL) is 12 months. frozen at -15C to -25C by customers

For opened products:

Once the cap is removed, assigned values are stable for15 days, when recapped immediately after use and stored at 2-8°C.

Once the stopper of the vial is punctured by the Dimension Vista® System, assigned values are stable for 15 days when stored on board the Dimension Vista System.

Real time calibrator shelf life is determined by comparing results of the calibrator levels stored at -15C and -25C with control calibrators stored at -70C. The Dimension Vista instrument is calibrated at each test point with -70C control calibrator. The -15C and -25C calibrator values are recovered versus the control calibration. Recovery versus time is monitored and percent change over time is determined. In addition to frozen storage condition, the calibrator levels were tested, in real time, after thawing at 2- 8°C for 15 days to claim 15 days 2-8C stability. Defined acceptance criteria were met at all conditions.

Values for the each level of calibrator are assigned to using multiple Dimension Vista instruments and multiple reagent lots calibrated with master pools whose values are traceable to the Progesterone reference method, Isotope dilution Mass Spectrometry (ID/GC/MS). The bottle value for each level is the mean of 45 replicates.

Stability testing and value assignment studies were done using the Dimension Vista® 1500 Clinical Chemistry System.

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Siemens Healthcare Diagnostics Dimension Vista® Progesterone Calibrator K#130698

6: Device Intended Use:

Calibrator

The PROG CAL is an in vitro diagnostic product for the calibration of the Progesterone method on the Dimension Vista® System.

7. Medical device to which equivalence is claimed:

Substantial Equivalence:

The Dimension Vista® PROG CAL Calibrator (KC637) is substantially equivalent to the Dimension Vista® LOCI 9 Calibrator, (K113373) cat. # KC647.

Comparison to Predicate Device:

The proposed Siemens Healthcare Diagnostics Dimension Vista® Progesterone Calibrator (PROG CAL) and the predicate Dimension Vista® LOCI 9 Calibrator are both in vitro diagnostic products for the calibration of the Dimension Vista® Progesterone method on the Dimension Vista® System.

A comparison summary of the features of the products is included in the following table.

Calibrator:

Item	DeviceProgesterone Calibrator(PROG CAL)	PredicateLOCI 9 Calibrator((K113373))
Similarities
Intended Use	The PROG CAL is an in vitrodiagnostic product for thecalibration of the Progesteronemethod on the Dimension Vista®System.	The LOCI 9 CAL is an in vitrodiagnostic product for thecalibration of the progesterone(PROG) method on theDimension Vista® System.
Traceability	Isotope Dilution gaschromatography massspectrometry (ID/GC/MS)reference measurementprocedure	Isotope Dilution gaschromatography massspectrometry (ID/GC/MS)reference measurementprocedure
TargetConcentrations	Level A 0 ng/mLLevel B 1.00 ng/mLLevel C 8.00 ng/mLLevel D 20.0 ng/mLLevel E: 44.0 ng/mL	Level A 0 ng/mLLevel B 1.00 ng/mLLevel C 8.00 ng/mLLevel D 20.0 ng/mLLevel E: 44.0 ng/mL
Form	Frozen Liquid	Frozen Liquid
Differences
Matrix	human serum base	Bovine serum base

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Siemens Healthcare Diagnostics Dimension Vista® Progesterone Calibrator K#130698

Comments on Substantial Equivalence:

The Siemens Healthcare Diagnostics Dimension Vista® Progesterone Calibrator (PROG CAL) and Dimension Vista® LOCI 9 calibrator (LOCI 9 CAL) are both frozen liguid calibrators, traceable to the Isotope Dilution gas chromatography mass spectrometry (ID/GC/MS) reference measurement procedure for progesterone, for use in the calibration of the Dimension Vista® Progesterone assay (PROG) on the Dimension Vista® System

8. Conclusion:

The Siemens Healthcare Diagnostics Dimension Vista® Progesterone Calibrator (PROG CAL) and Dimension Vista® LOCI 9 calibrator (LOCI 9 CAL) are substantially equivalent in design and intended use.

Anna Marie Kathleen Ennis Regulatory Affairs Manager April 5, 2013

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or ribbons extending upwards.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 5, 2013

Siemens Healthcare Diagnostics, Inc. C/O Anna Marie Kathleen Ennis 500 GBC Dr., M/S 514 P. O. Box 6101 NEWARK DE 19714

Re: K130698

Trade/Device Name: Dimension Vista® Progesterone Calibrator (PROG CAL) Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: March 11, 2013 Received: March 18, 2013

Dear Ms. Ennis:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Carol C. Benson -S for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): ___K130698

Dimension Vista® Progesterone Calibrator (PROG CAL) Device Name: ____

Indications for Use. The PROG CAL is an in vitro diagnostic product for the calibration of the Progesterone (PROG) assay on the Dimension Vista® System.

AND/OR Over-The-Counter Use Prescription Use x (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Yung W. @han -S

Division Sign-Off Office of In Vitro Devices and Radiologic Health

K130698 510(k)

Page 1 of 1

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.