LIAISON 25 OH VITAMIN D

K032844 · DiaSorin, Inc. · MRG · Feb 12, 2004 · Clinical Chemistry

Device Facts

• Record ID: K032844
• Device Name: LIAISON 25 OH VITAMIN D
• Applicant: DiaSorin, Inc.
• Product Code: MRG · Clinical Chemistry
• Decision Date: Feb 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1825
• Device Class: Class 2

Intended Use

The LIAISON® 25 OH Vitamin D Assay uses chemiluminescent immunoassay (CLIA) technology intended for the quantitative determination of 25hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population

Device Story

LIAISON® 25 OH Vitamin D Assay is an automated chemiluminescent immunoassay (CLIA) for quantitative measurement of 25-hydroxyvitamin D in human serum or plasma. Input: patient serum/plasma samples. Principle: competitive immunoassay; specific antibody-coated magnetic particles compete with isoluminol-labeled Vitamin D for binding sites. Output: light signal (relative light units) measured by photomultiplier, inversely proportional to analyte concentration. Used in clinical laboratories; operated by laboratory technicians. Results assist clinicians in assessing vitamin D sufficiency and managing adult patients. Benefits: provides automated, standardized quantitative assessment of vitamin D status compared to manual RIA methods.

Clinical Evidence

Bench testing only. Performance evaluated via analytical sensitivity (<2.0 ng/mL), functional sensitivity (7.0 ng/mL), and total precision (6-13% CV). Linearity confirmed (r=0.98). Interference testing showed no significant impact from bilirubin, hemoglobin, cholesterol, or triglycerides. Method comparison with predicate RIA yielded a correlation coefficient of 0.88. Reference range established using 98 healthy volunteers (9.5-52.0 ng/mL). No clinical outcome studies provided.

Technological Characteristics

Chemiluminescent immunoassay (CLIA); magnetic particle solid phase; isoluminol derivative (ABEI) tracer; photomultiplier detection. Automated platform. Sample types: serum and EDTA plasma. Reagents: polyclonal antibody specific for 25-(OH)-D2/D3. Stored master curve calibration.

Indications for Use

Indicated for quantitative determination of 25-hydroxyvitamin D and other hydroxylated vitamin D metabolites in human serum or plasma to assess vitamin D sufficiency in adult populations.

Regulatory Classification

Identification

A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.

Special Controls

*Classification.* Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and (2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.

Predicate Devices

• DiaSorin 25-Hydroxyvitamin D 1231 RIA

Submission Summary (Full Text)

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FEB 1 2 2004

# 510(k) Summary

SUBMITTED BY:

David Ikeda DiaSorin Inc. 1951 Northwestern Ave. P.O. Box 285 Stillwater, MN 55082-0285 651.351.5592 Voice 651.351.5669 Fax May 05, 2003

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

NAME OF DEVICE: Trade Name Common Names/Descriptions:

Classification Name:

LIAISON® 25 OH Vitamin D Assay Automated chemiluminescent immunoassay for the quantitative determination of 25 OH Vitamin D Vitamin D Test System

PREDICATE DEVICE:

DiaSorin 25-Hydroxyvitamin D 1231 RIA

INTENDED USE: The LIAISON® 25 OH Vitamin D Assay uses chemiluminescent immunoassay (CLIA) technology intended for the quantitative determination of 25hydroxyvitamin D (25-OH-D) and other hydroxylated vitamin D metabolites in human serum or plasma to be used in the assessment of vitamin D sufficiency. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions in an adult population

DEVICE DESCRIPTION: The method for quantitative determination of 25 OH Vitamin D is a direct, competitive chemiluminescence immunoassay (CLIA). Specific antibody to Vitamin D is used for coating magnetic particles (solid phase) and Vitamin D is linked to an isoluminol derivative. During the incubation, 25 OH Vitamin D is dissociated from its binding protein, and competes with labeled Vitamin D for binding sites on the antibody. After the incubation, the unbound material is removed with a wash cycle, Subsequently, the starter reagents are added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is inversely proportional to the concentration of 25 OH Vitamin D present in calibrators, controls, or samples.

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| Feature | 25 OH Vitamin D RIA | LIAISON® 25 OH Vitamin D Assay |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte | 25-(OH)-D2/D3 | 25-(OH)-D2/D3 |
| Intended<br>Use | FOR <i>IN VITRO</i> DIAGNOSTIC USE.<br>This kit is intended for the quantitative<br>determination of 25-hydroxyvitamin D<br>(25-OH-D) and other hydroxylated<br>vitamin D metabolites in human serum or<br>plasma to be used in the assessment of<br>vitamin D sufficiency. Assay results<br>should be used in conjunction with other<br>clinical and laboratory data to assist the<br>clinician in making individual patient<br>management decisions in an adult<br>population | FOR <i>IN VITRO</i> DIAGNOSTIC USE.<br>The LIAISON® 25 OH Vitamin D Assay<br>uses chemiluminescent immunoassay<br>(CLIA) technology for the quantitative<br>determination of 25-hydroxyvitamin D<br>(25-OH-D) and other hydroxylated<br>vitamin D metabolites in human serum or<br>plasma to be used in the assessment of<br>vitamin D sufficiency. Assay results<br>should be used in conjunction with other<br>clinical and laboratory data to assist the<br>clinician in making individual patient<br>management decisions in an adult<br>population |
| Antisera | Polyclonal specific for 25-(OH)-D2/D3 | Polyclonal specific for 25-(OH)-D2/D3 |
| Tracer | 125I radiolabeled 25-(OH)-D analog | Chemiluminescent ABEI labeled 25-<br>(OH)-D analog |
| Standards | Five concentrations, human serum based,<br>extracted identically to controls and<br>patient samples | Stored Master Curve based on 10 points,<br>derived from serum based standards<br>extracted identically to controls and<br>patient samples |
| Kit | Two levels, human serum based,<br>extracted identically to standards and<br>patient samples | Two levels, horse serum based, extracted<br>identically to patient samples |
| Controls | Two levels, human serum based,<br>extracted identically to standards and<br>patient samples | Two levels, horse serum based, extracted<br>identically to patient samples |

# TECHNOLOGICAL COMPARISON TO PREDICATE:

PERFORMANCE DATA: A summary of performance data is shown below.

| Parameter | Performance Results |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitivity (analytical) | < 2.0 ng/mL |
| Sensitivity (Functional) | 7.0 ng/mL |
| Total Precision (%CV) | 6% - 13% |
| Recovery (mean) | 109% ± 18% |
| Linearity | $y = 0.98x + 4.1; r = 0.98$ |
| Endogenous Substance Interference | No significant interference observed at the following concentrations: Bilirubin (30 mg/dL); hemoglobin (250 mg/dL); Cholesterol (125 mg/dL); Triglycerides (1000 mg/dL) |
| Sample Types | Serum and EDTA Plasma are equivalent |
| Reference Range | 9.5 to 52.0 ng/mL |

Analytical sensitivity was tested for three lots of materials, giving values less than 2.0 ng/mL for each lot (1.7 ng/mL; 1.6 ng/mL; and 1.5 ng/mL respectively). Functional sensitivity was determined from serial dilutions as 7.0 ng/mL. Total precision was determined to be 6% to 13%CV across the range of the assay according to NCCLS

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### Addendum to DiaSorin LIAISON® 25 OH Vitamin D 510(k) Premarket Notification K032844

guidelines. Samples diluted linearly with a correlation coefficient of 0.98. Serum and EDTA plasma matrices gave equivalent results. The 25 OH Vitamin D in samples stored at 2°C - 8°C for up to 5 days gave equivalent results to fresh samples. Samples subjected to up to 5 freeze/thaw cycles also gave equivalent results to fresh samples. No carry-over was observed in testing low concentration samples directly after high concentration samples. The LIAISON® method correlated well with the DiaSorin RIA method, with a correlation coefficient of 0.88. The reference range established using 98 samples from apparently healthy normal volunteers, collected in the southwestern United States in late autumn, was 9.5 ng/mL to 52.0 ng/mL (2.5th to 97.5tt percentiles)

CONCLUSIONS: These data demonstrate the safety and effectiveness of the LIAISON® 25 OH Vitamin D Assay for its intended in vitro diagnostic use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized representation of three overlapping, curved lines, which are meant to symbolize growth and progress.

Public Health Service

FEB 1 2 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. David M. Ikeda Manager, Regulatory Affairs & Quality Systems Diasorin, Inc. 1951 Northwestern Aveneu P.O. Box 285 Stillwater, MN 55082-0285

k032844 Re:

K0326 11
Trade/Device Name: Liaison® 25-OH Vitamin D Kit Liaison® Control 25-OH Vitamin D Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Code: MRG; JJX Dated: January 6, 2004 Received: January 7, 2004

Dear Mr. Ikeda:

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 for use stated in the 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 I·DA'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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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 [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. 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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### INDICATIONS FOR USE

510(k) Number (if known):

LIAISON® Control 25 OH Vitamin D Device Name:

K032844

Indications for Use:

The LIAISON® Control 25 OH Vitamin D Set is intended for use as assayed quality The LIAISON - Ochtrol 26 OFF accuracy and precision of the LIAISON® 25 OH Vitamin D immunoassay.

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

Concurrence of CDRH, Office of Device Evaluation

Division Sign-Of

| Prescription Use: | ✓ |
|--------------------------|---|
| OR Over-the-Counter Use: | |

(Per 21 CFR 801.109)

Office of In Vitro Diagnostic Device Evaluation and Safety

Page

510(k) K032844

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| | Indications for Use |
|---------------------------|---------------------|
| 510(k) Number (if known): | K03 2844 |

Device Name:

LIAISON® 25-OH Vitamin D Kit

Indications For Use:

This kit is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-This kit is intended 101 the qualinazires in human serum or plasma to be used in D) and other nythoxyrated framing is now. Assay results should be used in conjunction the assessment of Viammir D barreter of assist the clinician in making individual patient management decisions in an adult population.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

OR

Over-The-Counter Use:

Carl Benam
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k032844

LS-25D-072 Rev D

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