LIAISON N-TACT PTH

K033426 · DiaSorin, Inc. · CEW · Feb 12, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033426
• Device Name: LIAISON N-TACT PTH
• Applicant: DiaSorin, Inc.
• Product Code: CEW · Clinical Chemistry
• Decision Date: Feb 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended Use

The LIAISON® N-tact™ PTH Assay is a chemiluminescent immunoassay to be used with the LIAISON® Analyzer for the quantitative determination of intact human parathyroid hormone in serum or EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions. The LIAISON® N-tact™ PTH Control Set is intended for use as an assayed quality control sample to monitor the accuracy and precision of the DiaSorin LIAISON® N-tact™ PTH immunoassay.

Device Story

Automated chemiluminescent immunoassay (CLIA) for quantitative measurement of intact human parathyroid hormone (PTH) in serum or EDTA plasma. Operates on LIAISON® Analyzer. Principle: direct, two-site sandwich immunoassay; solid phase coated with affinity-purified antibody (39-84 sequence); second antibody (1-34 region) conjugated to isoluminol derivative. Sample incubation allows PTH binding to solid phase and conjugated antibody; wash cycle removes unbound material; starter reagents initiate flash chemiluminescent reaction. Photomultiplier measures light signal (RLU) proportional to PTH concentration. Used in clinical laboratories; results assist clinicians in differential diagnosis of hypercalcemia and hypocalcemia and patient management decisions.

Clinical Evidence

Bench testing only. Analytical sensitivity ≤ 1.0 pg/mL; functional sensitivity 2.1 pg/mL. Assay range 2.5–2000.0 pg/mL. Total precision < 10% CV (35–1289 pg/mL). Recovery 100.5% ± 7.3%. Linearity r=0.98. Correlation with predicate r=0.992 (p=0.172). No significant interference from hemoglobin; <15% interference from triglycerides or bilirubin. Freeze/thaw stability confirmed (p=0.968).

Technological Characteristics

Chemiluminescent immunoassay (CLIA). Solid phase: affinity-purified antibody (39-84). Tracer: isoluminol-labeled polyclonal antibody (1-34). Energy source: LIAISON® Analyzer (photomultiplier detection). Sample types: serum, EDTA plasma. Calibration: stored master curve (10 points).

Indications for Use

Indicated for quantitative determination of intact human parathyroid hormone (PTH) in serum or EDTA plasma to aid in differential diagnosis of hypercalcemia and hypocalcemia related to calcium metabolism disorders. For use by clinicians in conjunction with other clinical/laboratory data.

Regulatory Classification

Identification

A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Predicate Devices

• DPC Coat-A-Count® Intact PTH IRMA

Submission Summary (Full Text)

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K0334-26

DiaSorin LIAISON® N-tact™ PTH 510(k) Premarket Notification

FEB 1 2 2004

## 510(k) SUMMARY

SUBMITTED BY:

David M. Ikeda DiaSorin, Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 651.351.5592 Voice 651.351.5669 Fax October 22, 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:<br>Trade Name: | LIAISON® N-tact™ PTH Assay<br>LIAISON® N-tact™ PTH Control Set |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Common Names/Descriptions: | Automated chemiluminescent<br>immunoassay for the quantitative<br>determination of human parathyroid<br>hormone (PTH) in serum or plasma. |
| Classification Name: | Parathyroid hormone test system |

PREDICATE DEVICE:

DPC Coat-A-Count® Intact PTH IRMA

INTENDED USE: The LIAISON® N-tact™ PTH Assay is a chemiluminescent immunoassay to be used with the LIAISON® Analyzer for the quantitative determination of intact human parathyroid hormone in serum or EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.

The LIAISON® N-tact™ PTH Control Set is intended for use as an assayed quality control sample to monitor the accuracy and precision of the DiaSorin LIAISON® N-tact™ PTH immunoassay.

98

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DEVICE DESCRIPTION: The method for quantitative determination of PTH is a direct, two site, sandwich type chemiluminescence immunoassay (CLIA). Affinity-purified antibody to the 39-84 amino acid sequence of PTH is coated to the solid phase. The second affinity-purified antibody to the 1-34 region is conjugated to an isoluminol derivative. During the incubation, PTH binds to the solid phase, and is subsequently bound by the isolumino! conjugated antibody. After the incubation, the unbound material is removed with a wash cycle. The starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of PTH present in calibrators, controls, or samples.

| Assay /<br>Feature | DPC | Coat-A-Count® PTH<br>Assay* | LIAISON® N-tact™ PTH Assay |
|--------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyte | Human Parathyroid Hormone | Human Parathyroid Hormone | Human Parathyroid Hormone |
| Intended<br>Use | | FOR <i>IN VITRO</i> DIAGNOSTIC<br>USE.<br>Coat-A-Count® Intact PTH IRMA<br>is an immunoradiometric assay<br>designed for the quantitative<br>measurement of intact<br>parathyroid hormone<br>(parathyrin, PTH) in serum. It is<br>intended strictly for <i>in vitro</i><br>diagnostic use as an aid in the<br>differential diagnosis of<br>hypercalcemia and<br>hypocalcemia | FOR <i>IN VITRO</i> DIAGNOSTIC<br>USE.<br>The LIAISON® N-tact™ PTH<br>Assay is a chemiluminescent<br>immunoassay to be used with<br>the LIAISON® Analyzer for the<br>quantitative determination of<br>intact human parathyroid<br>hormone in serum or EDTA<br>plasma. Measurements of<br>parathyroid hormone levels are<br>used in the differential<br>diagnosis of hypercalcemia and<br>hypocalcemia resulting from<br>disorders of calcium<br>metabolism. Assay results<br>should be used in conjunction<br>with other clinical and<br>laboratory data to assist the<br>clinician in making individual<br>patient management decisions |

TECHNOLOGICAL COMPARISON TO PREDICATE:

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| Antisera | Polyclonal specific for PTH (44- 84) | Polyclonal specific for PTH (39- 84) |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Tracer | 125I-labelled polyclonal antibody<br>to PTH (1-34) | Chemiluminescent ABEI<br>labeled polyclonal antibody to<br>PTH (1-34) |
| Standards | Seven lyophilized serum based<br>controls to be reconstituted in<br>water representing<br>concentrations from 0 to 3000<br>pg/mL | Stored Master Curve based on<br>10 points, derived from serum<br>based standards representing<br>concentrations from 2.5 to 2000<br>pg/mL. |
| Kit<br>Controls | Two concentrations of<br>lyophilized controls | Two concentrations of<br>lyophilized controls |

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

| Parameter | Performance Results |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Sensitivity (Analytical) | 1.0 pg/mL |
| Sensitivity (Functional) | 2.1 pg/mL |
| Assay Range | 2.5 - 2000.0 pg/mL |
| Total Precision (%CV) | < 10% in range from 35 - 1289 pg/mL |
| Recovery (Mean ± SD %) | 100.5% ± 7.3% |
| Linearity (Expected vs.<br>Observed) | y = 0.92x + 4.6; r = 0.98 |
| PTH Fragment Cross-reactivity | 1 - 34 < 0.1%   13 - 34 < 0.1%<br>39 - 68 < 0.1%   39 - 84 < 0.1%<br>44 - 68 < 0.1%   53 - 84 < 0.1%<br>7 - 84 90.5% |
| Endogenous Substance<br>Interferences | No significant interference observed from<br>hemoglobin; <15% interference from<br>triglycerides (800 mg/dL) or bilirubin (15<br>mg/dL). |
| Sample Types | Serum or EDTA Plasma |
| Reference Ranges | Normal: 7.0 - 82.0 pg/mL<br>Hypoparathyroidism: 0.0 - 21.0 pg/mL<br>Hyperparathyroidism: 48.6 - 368 pg/mL |

Analytical sensitivity was determined from the assessment of three lots of materials. Analytical sensitivity was defined as the concentration corresponding to the signal obtained at two standard deviations from the mean of the signal of the zero concentration samples. Analytical sensitivity determined by this method was ≤ 1.0 pg/mL for all lots. Functional sensitivity, determined as the mean concentration at which the mean imprecision, expressed as %CV, exceeds 20%, was determined from serial dilution to be 2.1 pg/mL. Linearity of dilution was demonstrated using nineteen samples and four lots of materials. The correlation

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coefficient of the linear regression of the Expected Concentration vs. Observed Concentration was 0.98. Inter-assay precision, expressed as %CV, was < 10% over a concentration range from 35 - 1290 pg/mL. Recovery was assessed by spiking synthetic PTH at known concentrations into serum samples. Mean percent recovery (± SD) was 100.5% ± 7.3%. Samples subjected to 4 freeze/thaw cycles gave results equivalent to fresh samples (paired t test p value of 0.968). No carryover was observed in testing low concentration samples directly after high concentration samples. The LIAISON® method correlated well with the predicate device (r = 0.992), giving equivalent values when evaluated by Student's t test (p = 0.172). The reference range established from a population of normal, apparently healthy volunteers (7.0 - 82.0 pg/mL) utilizing the 2.5th to 97.50 percentiles, was very similar to the predicate device (12 - 72 pg/mL). Reference ranges were also determined for subjects with an established diagnosis of either hypoparathroidism or hyperparathyroidsim, 0.0 – 21.0 pg/mL and 48.6 - 368 pg/mL respectively.

### CONCLUSIONS:

These data demonstrate the safety and effectiveness of the LIAISON® N-tact™ PTH Assay for its intended in vitro diagnostic use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

FEB 1 2 2004

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

Re: k033426

Trade/Device Name: Liaison® Control N-tact™ PTH Liaison® N-tact™ PTH Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW; 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 commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been rcclassified 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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#### Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) r no lotet 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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K033426 DiaSorin LIAISON® N-tact™ PTH Premarket Notification

# INDICATIONS FOR USE

510(k) Number (if known): K033426

Device Name:

LIAISON® Control N-tact™ PTH

Indications for Use:

The LIAISON® Control N-tact™ PTH is intended for use as assayed quality control The LIAIOON - oontrol N tax:
materials to monitor the accuracy and precision of the LIAISON® N-tact™ PTH immunoassay.

Carol Benam

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k033426

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use: ✓

OR Over-the-Counter Use:

(Per 21 CFR 801.109)

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## INDICATIONS FOR USE

510(k) Number (if known): 10334240

Device Name:

LIAISON® N-tact™ PTH

Indications for Use:

The LIAISON® N-tact™ PTH is a chemiluminescent immunoassay to be used with the LIAISON® Analyzer for the quantitative determination of intact human parathyroid hormone in serum or EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. Assay results should be used in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions.

Carol C Benson
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K033426

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use:

OR Over-the-Counter Use:

(Per 21 CFR 801.109)

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