NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022

K040813 · Nichols Institute Diagnostics · CEW · Jun 8, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040813
• Device Name: NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022
• Applicant: Nichols Institute Diagnostics
• Product Code: CEW · Clinical Chemistry
• Decision Date: Jun 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended Use

The Nichols Advantage® Chemiluminescence Intact Parathyroid Hormone Immunoassay is intended for use with the Nichols Advantage® Specialty System for the quantitative determination of intact parathyroid hormone in human EDTA plasma, heparinized plasma and serum. 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. Measurements of intact parathyroid hormone levels are also used as an aid in monitoring therapeutic intervention of secondary hyperparathyroidism that frequently occurs in chronic kidney disease. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

Device Story

Two-site chemiluminometric immunoassay; measures intact parathyroid hormone (PTH) in serum, EDTA plasma, or heparinized plasma. Used with Nichols Advantage Specialty System; operated by laboratory personnel. Provides quantitative PTH levels to assist clinicians in diagnosing calcium metabolism disorders and monitoring secondary hyperparathyroidism in chronic kidney disease. Results interpreted alongside other clinical data to guide patient management.

Clinical Evidence

No clinical trials; bench testing only. Precision/reproducibility established via intra-assay (n=20) and inter-assay (n=20) studies. Method comparison (n=190) against IRMA predicate showed correlation (r=0.99, y=0.98x-0.3). Matrix comparison (n=47-48) evaluated serum, EDTA, and heparinized plasma; bias found within analytical variation. Stability studies confirmed sample integrity for up to 48 hours under specified storage conditions.

Technological Characteristics

Two-site chemiluminometric immunoassay. Analyte: Intact Parathyroid Hormone. Specimen types: serum, EDTA plasma, heparinized plasma. System: Nichols Advantage Specialty System. No change in core technology from predicate.

Indications for Use

Indicated for quantitative determination of intact parathyroid hormone in serum, EDTA plasma, and heparinized plasma to aid in differential diagnosis of hypercalcemia and hypocalcemia and monitoring secondary hyperparathyroidism in chronic kidney disease patients.

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

• Nichols Advantage® Chemiluminescence Intact Parathyroid Hormone (K962598)

Submission Summary (Full Text)

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#### 510(k) Summary 11.0

This summary of safety and effectiveness is being submitted in accordance with the requirement: of SMDA 1990 and 21 CFR 807.92.

## 1. Name of Manufacturer, Contact Person and Date Summary Prepared:

Nichols Institute Diagnostics 1311 Calle Batido San Clemente, CA 92673 Phone: [phone] FAX: [phone] Contact Person: Jimmy Wong, Manager of Clinical and Technical Affairs Date Prepared: March 25, 2004

### 2. Device Name:

| Trade/Proprietary Name: | Nichols Advantage® Chemiluminescence Intact Parathyroid<br>Hormone |
|-------------------------|----------------------------------------------------------------------------------|
| Common Name: | Radioimmunoassay, Parathyroid Hormone |
| Classification Name: | Parathyroid hormone test system |
| 3. Classification: | Class II<br>Regulation Number: 862.1545<br>Product Code: CEW, Clinical Chemistry |
| Predicate Device: | Nichols Advantage Chemiluminescence Intact Parathyroid<br>Hormone |

#### Device Description: 4.

The Nichols Advantage Intact PTH assay contains sufficient reagents for 100 tests. The assay is a two-site chemiluminometric assay specific for Intact PTH.

#### Indications for Use: 5.

"The Nichols Advantage® Chemiluminescence Intact Parathyroid Hormone Immunoassay is intended for use with the Nichols Advantage Specialty System for the quantitative determination of intact parathyroid hormone in serum, EDTA plasma, and heparinized 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. Measurements of intact parathyroid hormone levels are also used as an aid in monitoring therapeutic intervention of secondary hyperparathyroidism that frequently occurs in chronic kidney disease. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions."

### 6. Comparison to Predicate Device:

- Heparinized plasma was added to the specimen matrix for Intact PTH testing. .
- Use of 6 different blood collection tubes was compared for similarities and differences for . Intact PTH testing, and results of comparative testing yield essentially equivalent results.
- Specimen stabilities have been included in the new labeling for EDTA plasma, . Heparinized plasma, and serum testing.
- New labeling and scientific references supporting use of Intact PTH testing in patients . with chronic kidney diseases were added.

### 7. Similarities:

- There is no change in technology from the original device cleared under K962598. .
#### Additional Performance Characteristics 8.

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- Crossreactivity to human PTH 7-84 was determined to be equimolar in the assay. .
- Crossreactivity to human PTHrP 1-40 was determined to not cross react in the assay. .

Conclusions: The device with modified labeling is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

JUN = 8 2004

Mr. Jimmy Wong Manager, Clinical and Technical Affairs Nichols Institute Diagnostics 1311 Calle Batido San Clemente, California 92673

k040813 Re:

K040013
Trade/Device Name: Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW Dated: March 20, 2004 Received: March 30, 2004

Dear Mr. Wong:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaren by (a) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce pror to they 2011-11-11 in accordance with the provisions of the Federal Food, Drug, de necs that have been that do not require approval of a premarket approval application (PMA). and Coometier fore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrerers, mains 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 it may be subject to bach additions (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 1 Icase oc advised that I Driv issualite or our device complies with other requirements of the Act that I Dr has intact and regulations administered by other Federal agencies. You must or any I catal statutes and sequirements, 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oogin maketag your courselence of your dever to a legally premarket nothleation: "The PDA misms of basification 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, of If you desire specific information about and approvince of your device, please contact the Office of of questions on the promionon and Safety at [phone]. Also, please note the In Viro Diagnostic Device Evanances and season ... ... ... ... ... ... ... ... ... ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . regulation entitied, "Wilsonanaing of responsibilities under the Act from the You may of amall 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): K040813

Device Name: Nichols Advantage Chemiluminescence Intact Parathyroid Hormone

Indications For Use:

The Nichols Advantage® Chemiluminescence Intact Parathyroid Hormone The Nichols Advantage Shemilaninessenos intact Partially System for the immunuassay is intended for ass internethyroid hormone in human EDTA plasma, quantitative uctermination of intast psucements of parathyroid hormone levels are used nepannized plasma and soram mercalcemia (abnormally high levels of calcium in the in the unlerential diagnolo of hyporoulow.levels of calcium in the blood) resulting from blood) and flypodioomia (abhermants of intact parathyroid hormone levels disorucis or odicially and in monitoring therapeutic intervention of secondary are also used an an all infinently occurs in chronic kidney disease. Assay results nypelparathyroldent that took with other clinical data to assist the clinician in making individual patient management decisions.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alberto Cals

Division Sign-

Office of In Vitro Diagnos Device Evaluation and S

510(k) k040813

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