STA® - Free PS Calibrator kit is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents for the calibration of free protein S assays by the immuno-turbidimetric method, STA® - Liatest® Free PS.

Device Description

The STA® - Free PS Calibrator kit is a set of lyophilized human plasmas used to create the calibration curve on an IVD instrument performing the immunoturbidimetric method for free protein S assays, STA® - Liatest® Free PS. Such IVD instruments being the STA® product line of medical device analyzers such as STA-R® and STA Compact®.

In the lyophilized state and uncompromised primary packaging, the product calibrator plasmas remain stable for a period of 18 months from the date of manufacture when stored at 2 - 8°C. In the reconstituted state, STA® - Free PS Calibrator have demonstrated to be stable for 4 hours on board STA-R® and STA Compact®.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the STA® - Free PS Calibrator. While it details the device's intended use, technological characteristics, and substantial equivalence to a predicate device, it does not include a specific study or detailed data proving the device meets acceptance criteria.

The text states, "performance data enclosed in this notice further demonstrates suitability for the intended use," but this data is not present in the provided excerpts. As such, I cannot create a table of acceptance criteria and reported device performance, nor can I provide details on sample sizes, ground truth establishment, or specific study types.

However, based on the available information, I can address some of the requested points if such a study were described:

A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided text.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not present in the provided text.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided text.
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: This is a calibrator for an in-vitro diagnostic test, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be applicable to this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a calibrator, not an algorithm. Therefore, a standalone performance study in the context of "algorithm only" is not applicable. However, the text mentions "performance data enclosed in this notice further demonstrates suitability for the intended use," which would imply standalone performance data for the calibrator itself, likely focusing on its ability to establish a correct calibration curve and maintain stability. The specifics of this performance data are not provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a calibrator, the "ground truth" typically involves reference values or certified reference materials against which the calibrator's assigned values are validated. The text does not explicitly state how the ground truth for the performance data (mentioned but not included) was established, but it would involve comparing the calibrator's output to known, highly accurate reference standards.
The sample size for the training set: This is a calibrator device, not a machine learning algorithm that requires a "training set" in the conventional sense. Performance evaluation would involve evaluating the calibrator's characteristics (e.g., linearity, stability, accuracy of assigned values) using multiple lots, instruments, and potentially comparison to established reference methods or predicate devices. The relevant "sample size" for such an evaluation is not provided.
How the ground truth for the training set was established: As mentioned in point 8, a "training set" in the AI/ML context is not applicable. For a calibrator, its "ground truth" (i.e., its assigned values and performance characteristics) would be established through a rigorous process of metrological traceability, often involving primary reference materials or international standards for free protein S. The text does not detail this process for the STA® - Free PS Calibrator.

In summary, while the document confirms the device's intended use and the FDA's substantial equivalence determination, it does not provide the specific performance data or a detailed study description that would allow for the complete fulfillment of your request regarding acceptance criteria and their proof.

Summary

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92113

Attachment - 4

510(k) SUMMARY

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Umberto V. Parrotta Diagnostica Stago, Inc. Five Century Drive Parsippany, New Jersey 07054

NOV 1 8 2009

Phone: (973) 631-1200. x-2044 Facsimile: (973) 695-0095

Contact Person: Umberto V. Parrotta

Date Prepared: July 10, 2009

Name of Device and Name/Address of Sponsor:

STA® - Free PS Calibrator

Diagnostica Stago, Inc. Five Century Drive Parsippany, New Jersey 07054

Common or Usual Name:

Secondary Calibrator. .
IVD Calibrator.
IVD Coagulation Calibration Device.

Classification Name:

Calibrator, Secondary. .

Predicate Device:

HemosIL™ (K041905). .

Purpose of the Traditional 510(k) Notice:

The STA® Free PS Calibrator is a new calibration kit for Free Protein S . assays using the STA® product line of IVD analyzers (STA-R® and STA Compact®).

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510(k) SUMMARY

Indication/Intended Use:

Technological Characteristics:

Substantial Equivalence:

The product, STA® - Free PS Calibrator and the predicate device, HemosILTM Calibration plasma are similar in indication/intended use, technology, principles of operation, and application of use (with IVD medical device analyzers) thus yielding no new questions in safety, effectiveness, or technology. In addition, performance data enclosed in this notice further demonstrates suitability for the intended use. Therefore, this concludes the product STA® Free PS Calibrator is substantially equivalent to the predicate device, HemosIL™ Calibration plasma.

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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 eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Diagnostica Stago, Inc. c/o Mr. Umberto V. Parrotta Director of Regulatory Affairs and Quality Assurance 5 Century Drive Parsippany, NJ 07054

Re: K092113

NOV 1 3 2009

Trade/Device Name: STA - Free PS Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: October 8, 2009 Received: October 9, 2009

Dear Mr. Parrotta:

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 class II (Special Controls), 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). This letter

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Page 2 - Mr. Parrotta

will allow you to begin marketing your device as described in your Section 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 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,

Qeena Philip

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Attachment - 1

Indications for Use

510(k) Number (if known):

K092113

Device Name:

STA® - Free PS Calibrator Kit

Indications for Use:

Prescription Use X ' (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 (OVD)

Reena Philip

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

510(k) k 092113

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.