The DiaSorin LIAISON® N-TACT® PTH Calibration Verifiers are assayed quality control materials intended for use in the quantitative verification of calibration and reportable range of the LIAISON® N-TACT® PTH Assay when performed on the LIAISON® Analyzer.

Device Description

The LIAISON® N-TACT® PTH Calibration Verifiers consist of four levels. Each vial contains Iyophilized pooled human plasma spiked with PTH. The calibration verifiers are reconstituted with 2.0 mL of deionized or distilled water, allowed to sit for 10 minutes, and mixed gently before use. The calibration verifier set is provided with targeted PTH concentrations of 20, 150, 350 and 1500 pg/mL. The four levels were chosen to incorporate the range of the LIAISON® N-TACT® PTH Assay and to challenge the decision points of clinical importance for PTH.

AI/ML Overview

The provided document describes a premarket notification for the DiaSorin LIAISON® N-TACT® PTH Calibration Verifiers. This device is an assayed quality control material, not an AI/ML powered device, and therefore the concepts of test sets, ground truth, expert adjudication, MRMC studies, or standalone performance do not apply. The document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance.

Here's an analysis based on the information provided, reinterpreting the "acceptance criteria" and "study" in the context of a quality control material seeking substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (calibration verifiers/quality control materials), the "acceptance criteria" revolve around demonstrating that the new device performs similarly to or meets the requirements for a quality control material and is substantially equivalent to an existing predicate device. The performance is assessed by comparing its characteristics and intended use to the predicate.

Acceptance Criteria (Inferred)	Reported Device Performance (LIAISON® N-TACT® PTH Calibration Verifiers)
Intended Use Equivalence: Must be intended for similar quality control/calibration verification in a PTH assay.	Assayed quality control samples for use in the quantitative verification of calibration and reportable range of the LIAISON® N-TACT® PTH Assay. (Similar purpose to predicate's "assayed quality control samples to monitor accuracy and precision").
Analyte Equivalence: Must measure the same analyte.	Parathyroid Hormone
Matrix Equivalence: Must have a similar biological matrix.	Pooled human plasma with stabilizers and 0.2% Proclin® 300
Format Equivalence: Must have a similar physical form.	Lyophilized
Storage Conditions Equivalence: Must have similar storage requirements.	2 - 8°C before reconstitution, -20°C after reconstitution
Handling Equivalence: Must have similar reconstitution and handling procedures.	Reconstitute with 2 mL deionized or distilled H2O, allow to dissolve on bench top for 10 minutes, mix thoroughly to ensure complete reconstitution
Volume Equivalence: Must have a similar final volume after reconstitution.	2.0 mL after reconstitution
Required Reagent Equivalence: Must be used with the same main assay.	LIAISON® N-TACT® PTH Assay
Processing Equivalence: Must be processed on the same instrument.	LIAISON® Analyzer
Appropriate Number of Levels: Must provide adequate levels for its intended use (calibration verification).	Four levels (20, 150, 350, 1500 pg/mL) chosen to incorporate the range of the LIAISON® N-TACT® PTH Assay and challenge decision points. (Predicate had two levels, new device has more, which is an improvement for calibration verification).

Study Proving Acceptance Criteria:

The "study" in this context is a substantial equivalence comparison to a legally marketed predicate device, the LIAISON® N-TACT® PTH Control Set (K033426). The provided text outlines this comparison, highlighting similarities and differences to demonstrate that the new device is as safe and effective as the predicate.

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

This concept is not applicable to this type of regulatory submission. There is no "test set" in the sense of patient data or algorithm performance evaluation. The "sample" here would refer to the characteristics of the calibration verifiers themselves, such as the different levels provided. The data provenance relates to the formulation of the human plasma, but not its origin in terms of "patient data."

Sample Size: The device consists of four levels of calibration verifiers.
Data Provenance: The matrix is "pooled human plasma." No specific country of origin or whether it's retrospective/prospective is detailed for the plasma source, as it's a raw material for a control.

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

This concept is not applicable. "Ground truth" in the context of AI/ML or diagnostic claim validation refers to an independent, highly accurate determination of a clinical condition. For a quality control material, the "truth" is the target concentration of PTH within the verifier, established during its manufacturing and assay. This is typically done through certified reference materials and established laboratory methods, not by clinical experts adjudicating cases.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This concept is not applicable. There is no "adjudication" of patient cases or diagnostic outputs for a quality control material.

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

This concept is not applicable. This device is a laboratory reagent (calibration verifier), not an AI-powered diagnostic tool used by human readers.

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

This concept is not applicable. This is a reagent, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the LIAISON® N-TACT® PTH Calibration Verifiers would be their assigned target PTH concentrations (20, 150, 350, 1500 pg/mL). These values are established during the manufacturing process using validated analytical methods and reference materials, ensuring the accuracy of the PTH concentration within each level of the verifier. It is not based on expert consensus, pathology, or outcomes data in a clinical sense, but rather on metrological traceability for an in-vitro diagnostic reagent.

8. The Sample Size for the Training Set

This concept is not applicable. There is no "training set" for this type of device.

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

This concept is not applicable. There is no "training set" or corresponding "ground truth" in the AI/ML sense.

Summary

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L093498

DiaSorin LIAISON® N-TACT® PTH Calibration Verifiers Premarket Notification

DEC 1 4 2009

510(k) SUMMARY 5.0

SUBMITTED BY:

Carol A. DePouw Regulatory/Clinical Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 351-5850 Fax (651) 351-5669 Email: carol.depouw@diasorin.com

NAME OF DEVICE:

Trade Name:

Common Names/Descriptions:

Classification Names:

Classification Number:

Product Code:

PREDICATE DEVICES :

LIAISON® N-TACT® PTH Calibration Verifiers

Parathyroid Hormone Assayed Quality Control Materials

Single (Specified) Analyte Controls (Assayed and Unassayed)

21 CFR 862.1660

JJX

LIAISON® N-TACT® PTH Control Set Reference K033426

DEVICE DESCRIPTION:

INTENDED USE:

KIT DESCRIPTION:

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DiaSorin LIAISON® N-TACT® PTH Calibration Verifiers Premarket Notification

The calibration verifier set is provided with targeted PTH concentrations of 20, 150, 350 and 1500 pg/mL. The four levels were chosen to incorporate the range of the LIAISON® N-TACT® PTH Assay and to challenge the decision points of clinical importance for PTH.

COMPARISON TO PREDICATE DEVICE:

The following table compares the LIAISON® N-TACT® PTH Calibration Verifiers to LIAISON® N-TACT® PTH Control Set.

Table 4: Table of Similiarities
Characteristic	Predicate DeviceLIAISON® N-TACT® PTHControl Set K033426	New DeviceLIAISON® N-TACT® PTHCalibration Verifiers
Intended Use	Assayed quality control samples tomonitor the accuracy and precisionof the LIAISON® N-TACT® PTHAssay	Assayed quality control samplesfor use in the quantitativeverification of calibration andreportable range of the LIAISON®N-TACT® PTH Assay
Analyte	Parathyroid Hormone	Parathyroid Hormone
Matrix	Pooled human plasma withstabilizers and 0.2% Proclin® 300	Pooled human plasma withstabilizers and 0.2% Proclin® 300
Format	Lyophilized	Lyophilized
ProductStorage	2 - 8°C before reconstitution-20°C after reconstitution	2 - 8°C before reconstitution-20°C after reconstitution
ProductHandling	Reconstitute with 2 mL deionizedor distilled H2O, allow to dissolveon bench top for 10 minutes, mixthoroughly to ensure completereconstitution	Reconstitute with 2 mL deionizedor distilled H2O, allow to dissolveon bench top for 10 minutes, mixthoroughly to ensure completereconstitution
Volume	2.0 mL after reconstitution	2.0 mL after reconstitution
RequiredReagent	LIAISON® N-TACT® PTH Assay	LIAISON® N-TACT® PTH Assay
Processing	LIAISON® Analyzer	LIAISON® Analyzer

Table 5: Table of Differences
Characteristic	Predicate DeviceLIAISON® N-TACT® PTHControl Set K033426	New DeviceLIAISON® N-TACT® PTHCalibration Verifiers
Levels	Two	Four

CONCLUSION:

The material submitted in this premarket notification is complete and supports the substantial equivalence of the LIAISON® N-TACT® PTH Calibration Verifiers to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

DiaSorin, Inc. c/o Ms. Carol A. DePouw Regulatory/Clinical Affairs Specialist 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285

DEC 1 4 2009

K093498 Re:

Trade Name: Liaison® N-Tact® PTH Calibration Verifiers Regulation Number: 21 CFR §862.1660 Regulation Name: Assayed Quality Control Materials Regulatory Class: Class I Product Codes: JJX Dated: November 11, 2009 Received: November 12, 2009

Dear Ms. DePouw:

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

I 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 yours,

Signature

Courtney C. 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

510(k) Number (if known): K093498

LIAISON® N-TACT® PTH Calibration Verifiers Device Name:

Indication For Use:

The DiaSorin LIAISON® N-TACT® Calibration Verifiers are assayed quality control materials intended for use in the quantitative verification of calibration and reportable range of the LIAISON® N-TACT® PTH Assay when performed on the LIAISON® Analyzer.

Prescription Use _ X (21 CFR Part 801 Subpart D)

Over the Counter Use (21 CFR Part 801 Subpart C)

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

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

signature

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

510(k) 12093448

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.