The STA® - Liatest® Free PS kits are intended for use with analyzers of the STA® line suitable with these reagents for the antigenic assay of free Protein S in plasma by the immuno-turbidimetric method.

Device Description

The STA® - Liatest® Free PS test kit is comprised of a suspension of latex microparticles coated with two (2) different mouse monoclonal anti-human free protein S antibodies stabilized with bovine albumin. Also in the test kit is an HEPES buffer. Testing is carried out in citrated human plasma via the immunoturbidimetric method utilizing external calibrator plasmas for the STA® - Liatest Free PS (the predicate device is pre-calibrated, not utilizing external calibrator plasmas).

AI/ML Overview

Here's an analysis of the provided text regarding the STA® - Liatest® Free PS device, focusing on acceptance criteria and study information.

It's important to note that the provided documents are a 510(k) Summary and an FDA clearance letter. These typically focus on demonstrating substantial equivalence to a predicate device rather than detailing specific de novo clinical study results, acceptance criteria, and performance for this specific device modification as if it were a new device. The provided text does not include detailed acceptance criteria or a dedicated study proving performance against such criteria in the way a clinical trial might for a novel device. Instead, it highlights the device's technological characteristics and argues for substantial equivalence to a previously cleared predicate device.

Therefore, the answers below are derived from the information available and will reflect the nature of a 510(k) submission, which often relies on comparison to a predicate rather than extensive new performance studies for minor modifications.

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not present specific, quantitative acceptance criteria (e.g., minimum sensitivity, specificity, accuracy targets) for the modified STA® - Liatest® Free PS device, nor do they report detailed performance results against such criteria. The primary "performance" being assessed here is its equivalence to the predicate device.

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantitative targets for the modified device. The submission focuses on demonstrating substantial equivalence to the predicate device (STA® - Liatest® Free Protein S, K010963) rather than proving performance against new, specific numerical thresholds.	Substantial Equivalence: The modified device (STA® - Liatest® Free PS) is deemed substantially equivalent to the predicate device in terms of indication/intended use, formulation/materials, technology, and safety. The primary difference (use of external calibrator vs. pre-calibrated) is accounted for in the procedure.
Technological characteristics matching predicate or being adequately addressed.	The modified device maintains the immuno-turbidimetric method using latex microparticles coated with anti-human free protein S antibodies. The change is in the calibration method.
Safety and Effectiveness (implied via equivalence).	The submission concludes "yielding no new questions in safety, effectiveness, or technology" compared to the predicate device.

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

The documents do not mention a specific "test set" and sample size for performance evaluation in the context of a new clinical study for this modified device. The determination of substantial equivalence relies on comparing the modified device's characteristics to those of the predicate device.

Sample Size for Test Set: Not specified.
Data Provenance: Not specified, as a new study with a specific data set for the modified device's performance is not detailed.

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

This information is not provided. Given that this is a 510(k) for a modification (calibration method) to an in-vitro diagnostic device, and not a de novo submission requiring extensive new clinical validation of diagnostic accuracy, expert consensus for ground truth on a new test set would not typically be a primary focus. The focus is on ensuring the calibration change does not negatively impact the performance established by the predicate.

4. Adjudication Method for the Test Set

Not applicable, as no new test set requiring expert adjudication for ground truth is described in the provided text.

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 device is an in-vitro diagnostic (IVD) kit for measuring Protein S in plasma using an automated analyzer (STA® line). It is not an AI-assisted diagnostic tool that involves human readers interpreting images or results, nor is it a device that would undergo an MRMC study.

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

This refers to an IVD device's standalone performance, which is inherent in its operation. The device is a "kit" that works with analyzers of the STA® line. Its performance would be based on its ability to accurately measure free Protein S. While the document asserts substantial equivalence, it doesn't detail a standalone performance study with specific metrics (e.g., precision, accuracy, linearity) for this specific modification's impact. Such studies would typically be part of the product development and validation for the modified device, but their results are summarized as "no new questions in safety, effectiveness, or technology" rather than presented in detail in the 510(k) summary.

7. The Type of Ground Truth Used

For an IVD device like this, "ground truth" typically refers to:

Accurate analyte concentrations: Established through reference methods, certified calibrators, or internal validation processes.
Clinical outcomes: Correlating measurements with patient disease status (e.g., deficiency vs. normal).

The document implies that the ground truth for establishing the performance of the predicate device (which the modified device is compared to) would have involved such methods. For the modified device, the "ground truth" for demonstrating equivalence would revolve around showing that the new calibration method yields results consistent with the predicate device and accurately reflects the concentration of Free Protein S. The mention of "external calibrator plasmas" for the modified device suggests that its calibration curve is established against known concentrations using these calibrators.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily relevant for machine learning or AI-driven devices. This IVD kit does not involve a machine learning algorithm that is "trained" on a dataset in the conventional sense. Its "training" involves the use of calibrators to establish a standard curve for quantitative measurement, but this is a different paradigm from AI training. Therefore, a "training set sample size" as commonly understood in AI/ML is not applicable.

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

As explained above, there is no "training set" in the AI/ML sense. For the calibration process, the "ground truth" is established by the Diagnostica Stago's STA® - Free PS Calibrator which are presumably plasmas with known, verified concentrations of free Protein S. The process of how those calibrator values were established (e.g., against a recognized reference method or material) is not detailed in these documents but would be part of the manufacturer's quality system and product development.

Summary

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Attachment - 5

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

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

Contact Person: Umberto V. Parrotta

Date Prepared: July 17, 2009

Name of Device and Name/Address of Sponsor:

STA® - Liatest® Free PS

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

Common or Usual Name:

Free Protein S IVD Device. .
IVD Factor Deficiency Test.

Classification Name:

Factor Deficiency Test. t

Predicate Device:

STA® Liatest® Free Protein S (K010963). .

Purpose of the Special 510(k) Notice:

STA® Liatest® Free PS is a modification of the Company's previously FDA . cleared device, STA® - Liatest® Free Protein S. Specifically, the currently marketed product (predicate device) is pre-calibrated, whereas the calibration for the modified device (the subject of this submission) is performed with a set of calibrator plasmas (Diagnostica Stago's STA® - Free PS Calibrator)
File: DSI-STA-LiatestFreeProteinS-Attachment-05v2-510(k)Summary.doc

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CONFIDENTIAL

Attachment - 5

510(k) SUMMARY

Indication/Intended Use:

Technological Characteristics:

Substantial Equivalence:

The STA® - Liatest® Free PS and the predicate device, STA® - Liatest® Free Protein S (K010963) are identical products regarding indication/intended use, formulation or materials of construction, technology, and safety. The primary difference between the subject product and predicate device is the use of an external calibrator for the subject product of this submission versus precalibration for the predicate device. This difference is accounted in the procedure section of the package insert. Based upon the aforementioned comparisons and those designated in the SE Comparison Chart, the product, STA® - Liatest Free PS and the predicate device, STA - Liatest - Free Protein S are similar in indication/intended use, technology, principles of operation, and application of use (with IVD medical devices) thus yielding no new questions in safety. effectiveness, or technology. Therefore, this concludes the product STA Liatest Free PS is substantially equivalent to the predicate device, STA® -Liatest® Free Protein S (K010963).

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DEC 2 2 2009

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

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

Re: K092170

Trade/Device Name: STA® Liatest® Free PS Regulation Number: 21 CFR 864.7290 Regulation Name: Factor Deficiency Test Regulatory Class: Class II Product Code: GGP Dated: November 25, 2009 Received: November 27, 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

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Page 2 -Mr. Parrotta

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 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,

ia m chor

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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CONFIDENTIAL

Attachment - 1

Indications for Use

510(k) Number (if known):

Device Name: STA®- Liatest® Free PS.

Indication 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 (OIVD) (

Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K092170

File: DSI-STA-LiatestFreeProteinS-Attachment-01-IndicationsForUseStatementForm.doc Page 1 of l

Regulation Number and Section

§ 864.7290 Factor deficiency test.

(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).