NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040

K033302 · Nichols Institute Diagnostics · CEW · Jan 26, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033302
• Device Name: NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040
• Applicant: Nichols Institute Diagnostics
• Product Code: CEW · Clinical Chemistry
• Decision Date: Jan 26, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended Use

The Nichols Advantage® Bio-Intact PTH (1-84) immunometric assay is intended for use with the Nichols Advantage® Specialty System to measure the levels of parathyroid hormone in serum and EDTA 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. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

Device Story

The Nichols Advantage Bio-Intact PTH (1-84) is an immunometric assay designed for use with the Nichols Advantage Specialty System. It quantifies parathyroid hormone (PTH) levels in human serum or EDTA plasma samples. The device operates as an automated immunoassay system in a clinical laboratory setting, managed by laboratory technicians or clinicians. The system transforms biochemical inputs into quantitative PTH concentration outputs. These results are provided to healthcare providers to assist in the differential diagnosis of calcium metabolism disorders, specifically hypercalcemia and hypocalcemia. By providing accurate PTH measurements, the device supports clinical decision-making regarding patient management. The device is intended for prescription use only.

Clinical Evidence

No new clinical trials; evidence consists of clinical correlation data regarding testing in patients with disorders of calcium metabolism and updated precision data analysis.

Technological Characteristics

Immunometric assay; utilizes established reagents and test protocols consistent with the previously cleared device. No changes to fundamental scientific technology or physical characteristics.

Indications for Use

Indicated for the measurement of Bio-Intact PTH (1-84) in adult patients, including those with disorders of calcium metabolism.

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 Bio-Intact PTH (1-84) (K033302)

Submission Summary (Full Text)

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K033302

## JAN 2 6 2004

Special 510(k) Nichols Advantage Bio-Intact PTH (1-84) Date Prepared: 1/23/04

#### Special 510k Summary 11.0

11.0 - Special 510K Summary
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

# of SMDA 1990 and 21 OF N 007.02.
1. Name of Manufacturer, Contact Person and Date Summary Prepared:

Nichols Institute Diagnostics 1311 Calle Batido San Clemente, CA 92673 Phone: [phone] FAX: [phone] FAX: [phone]
Contact Person: Jimmy Wong, Manager of Clinical and Technical Affairs Date Prepared: Jan. 23, 2004

### 2. Device Name:

Trade/Proprietary Name: Common Name: Classification Name: Classification: 3.

Nichols Advantage® Bio-Intact PTH (1-84) Parathyroid hormone immunoassay Radioimmunoassay, Parathyroid Hormone Class II Regulation Number: 862.1545 Product Code: CEW, Clinical Chemistry

- Nichols Advantage Bio-Intact PTH (1-84) K013992 Predicate Device: 4.
- Predicate Device: 5. Device Description. The Nierole Havemily in escence immunometric assay for quantifying PTH in human serum or plasma.
- PTH in human serum or plasma.
Intended Use: The Nichols Advantage® Bio-Intact PTH (1-84) immunometic assay is ్. Intended for use with the Nichols Advantage Specialty System to measure the levels of Intended for use will the Nielbis Advantage - Specifical of parathyroid hormone paratifying normone in Scrain and Leansis of hypercalcemia (abnormally high levels of levels are used in the unterentia (abnormally low levels of calcium in the blood) calcidin in the blood) and inypocalcem. Assay results should be used in conjunction resulting iron disorders of odloidin metalonion in making individual patient management decisions.
- 7 Conclusions: The Nichols Advantage Bio-Intact PTH (1-84) assay (FDA 510k K013992 Conclusions: The Nichols Auvantage Bio Intact The (de new information and labeling.

Changes to the Expected Values section were made in the labeling. A new reference range Oneliges to the Expoctod the results of that study were included in the new labeling. Study was performed, and the Nichols Bio-Intact PTH (1-84) assay are being Olimicians, and faberatery access that they can make informed decisions on how to conduct provided the new information of the such information can be used to interpret PTH ther own reliefice rango ottation and on original covariates that can affect calcium metabolism and results. New information is the brond hormone levels, and literature references that pertain to this topic.

The Special 510(k) includes new data on the clinical performance of the test performed on The Opeoful o ro(in) inola00 new clinical disorders of calcium metabolism. Serum calcium and PTH testing was performed on n=63 patients with surgically confirmed primary r TTT testing was porfernou "owith hypoparathyroidism, n=3 patients with hypercalcemia riyo mathyroldion, and n=276 normal individuals. By plotting the serum calcium (x-axis) uue to manghanty, and 11-270 normal scattergram was created. The scattergram serves versus the Bio into in the differential and hypocalcemia when both Bio-Intact PTH (1-84) and calcium testing are performed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 6 2004

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

k033302 Re:

Trade/Device Name: Nichols Advantage Bio-Intact PTH (1-84) Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW Dated: December 19, 2003 Received: December 31, 2003

Dear Mr. Wong:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon - 1 (x) pe instantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard) the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, in other with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (710t) that do not request to the general controls provisions of the Act. The I ou may, dicrerere, maines of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is classified (soral controls. Existing major regulations affecting your device can may be subject to such adultions retires in Regulations (CFR), Parts 800 to 895. In addition, FDA oe found in The 21, 21, 21, 2017 device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Drivisation of our device complies with other requirements of the Act that I DA has made a devel ministered by other Federal agencies. You must of any I cut all the Act's requirements, including, but not limited to: registration and listing (21 comply writtle and the 11th 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) This letter will anow you to oegin maing of substantial equivalence of your device to a legally prematics notification: "Tics Dr. I 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 you desire specific nevertising of your device, please contact the Office of of questions on the promote 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 Tou may oount oner getierers, 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.

Jean 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 Statement 3.0

### INDICATIONS FOR USE STATEMENT

510(k) Number:

Electrical (RTU 1 & 2)

Device Name:

Nichols Advantage Bio-Intact PTH (1-84)

3307

Indications for Use Statement: The Nichols Advantage® Bio-Intact PTH (1-84) immunometric assay is intended for use with the Nichols Advantage® Specialty System thindhomethous of parathyroid hormone in serum and EDTA plasma. to measurements of parathyroid hormone levels are used in the differential diagnosis of Mcasarements of parathylord northerels of calcium in the blood) and hypocalcemia nyporcalcomia (abnormally in the blood) resulting from disorders of calcium (abmornially low levelo 'er bandle be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

(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
(Optional Format 1-2-96)

Carol C Benson for Jean Cooper, DUM
Division Sign-Off

Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K033302 SPECIAL

Date Printed: 10/10/2003 Created by Jimmy Wong