LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913

K093498 · DiaSorin, Inc. · JJX · Dec 14, 2009 · Clinical Chemistry

Device Facts

• Record ID: K093498
• Device Name: LIAISON N-TACT PTH CALIBRATION VERIFIERS MODEL 310913
• Applicant: DiaSorin, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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 Story

LIAISON® N-TACT® PTH Calibration Verifiers are quality control materials used to verify calibration and reportable range of LIAISON® N-TACT® PTH Assay. Product consists of four levels of lyophilized pooled human plasma spiked with PTH and preservatives. Used in clinical laboratory settings on LIAISON Analyzer. Healthcare providers use output to verify assay performance and ensure accuracy of patient PTH measurements. Benefits include improved confidence in clinical decision-making regarding parathyroid hormone levels.

Clinical Evidence

No clinical data. Bench testing only. Precision/reproducibility studies conducted over 20 days and 5 days using multiple LIAISON analyzers and assay lots. Results demonstrated acceptable SD and %CV across four concentration levels (17.4 to 1303.5 pg/mL). Stability studies confirmed shelf-life, open-vial, and freeze-thaw performance.

Technological Characteristics

Lyophilized pooled human plasma spiked with PTH; contains stabilizers and 0.2% Proclin® 300. Four levels (20, 150, 350, 1500 pg/mL). Reconstituted with 2.0 mL deionized/distilled water. Analyzed via LIAISON® Analyzer. Storage: 2-8°C (pre-reconstitution), -20°C (post-reconstitution).

Indications for Use

Indicated for use as assayed quality control materials to verify calibration and reportable range of the LIAISON® N-TACT® PTH Assay on the LIAISON® Analyzer. No specific patient population, age, or gender is defined as this is an in vitro diagnostic control material.

Regulatory Classification

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.

Predicate Devices

• LIAISON® N-TACT® PTH Control Set (k033426)

Submission Summary (Full Text)

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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 [phone] Fax [phone] Email: [e-mail]

### 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:

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.

#### KIT 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.

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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 Device<br>LIAISON® N-TACT® PTH<br>Control Set K033426 | New Device<br>LIAISON® N-TACT® PTH<br>Calibration Verifiers |
| Intended Use | Assayed quality control samples to<br>monitor the accuracy and precision<br>of the LIAISON® N-TACT® PTH<br>Assay | Assayed quality control samples<br>for use in the quantitative<br>verification of calibration and<br>reportable range of the LIAISON®<br>N-TACT® PTH Assay |
| Analyte | Parathyroid Hormone | Parathyroid Hormone |
| Matrix | Pooled human plasma with<br>stabilizers and 0.2% Proclin® 300 | Pooled human plasma with<br>stabilizers and 0.2% Proclin® 300 |
| Format | Lyophilized | Lyophilized |
| Product<br>Storage | 2 - 8°C before reconstitution<br>-20°C after reconstitution | 2 - 8°C before reconstitution<br>-20°C after reconstitution |
| Product<br>Handling | Reconstitute with 2 mL deionized<br>or distilled H2O, allow to dissolve<br>on bench top for 10 minutes, mix<br>thoroughly to ensure complete<br>reconstitution | Reconstitute with 2 mL deionized<br>or distilled H2O, allow to dissolve<br>on bench top for 10 minutes, mix<br>thoroughly to ensure complete<br>reconstitution |
| Volume | 2.0 mL after reconstitution | 2.0 mL after reconstitution |
| Required<br>Reagent | LIAISON® N-TACT® PTH Assay | LIAISON® N-TACT® PTH Assay |
| Processing | LIAISON® Analyzer | LIAISON® Analyzer |

| Table 5: Table of Differences | | |
|-------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------|
| Characteristic | Predicate Device<br>LIAISON® N-TACT® PTH<br>Control Set K033426 | New Device<br>LIAISON® N-TACT® PTH<br>Calibration 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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- 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 [phone]. 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 [phone]. 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 [phone] 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