ELECSYS PARATHYROID HORMONE TEST SYSTEM

K992680 · Roche Diagnostics Corp. · CEW · Sep 28, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992680
• Device Name: ELECSYS PARATHYROID HORMONE TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: CEW · Clinical Chemistry
• Decision Date: Sep 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended Use

For the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia.

Device Story

The ELECSYS® Parathyroid Hormone Test System is an in vitro diagnostic immunoassay used for the quantitative measurement of parathyroid hormone (PTH) in human serum and plasma. The device utilizes a two-step sandwich immunoassay principle incorporating streptavidin-coated microparticles and electrochemiluminescence detection. It is designed for use on ELECSYS® 2010 and 1010 immunoassay analyzers. The system generates results using a 2-point calibration curve and a master curve provided via reagent bar code. The device is intended for use by clinical laboratory professionals to aid in the differential diagnosis of calcium metabolism disorders, specifically hypercalcemia and hypocalcemia. By providing accurate PTH levels, the system assists clinicians in evaluating parathyroid function and managing patients with abnormal calcium levels.

Clinical Evidence

Bench testing only. Performance characteristics compared to the predicate include within-run precision (3.4%–5.8% CV), total precision (4.3%–7.1% CV), and analytical sensitivity (1.20 pg/mL). Interference studies confirmed no significant impact from bilirubin, hemoglobin, intralipid, biotin, or rheumatoid factor at specified concentrations. No high-dose hook effect observed up to 17,000 U/mL.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection; streptavidin microparticles. Analyzers: ELECSYS® 2010 and 1010. Measuring range: 1.20-5000 pg/mL. Calibration: 2-point calibration with master curve via bar code. Connectivity: Integrated with ELECSYS® analyzers.

Indications for Use

Indicated for the quantitative determination of intact parathyroid hormone in human serum and plasma to assist in the differential diagnosis of hypercalcemia and hypocalcemia.

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 Intact Parathyroid Hormone (PTH) Immunoassay (K954418)

Submission Summary (Full Text)

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# 510(k) Summary

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics Corporation<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Priscilla A Hamill |
| | Date prepared: August 9, 1999 |
| Predicate device | The ELECSYS® Parathyroid Hormone Test System is equivalent to other devices legally marketed in the United States. We claim equivalence to the Nichols RIA test for Parathyroid Hormone (K954418). |
| Device Name | Proprietary name: ELECSYS® Parathyroid Hormone Test System |
| | Common name: Parathyroid Hormone Test |
| | Classification name: Radioimmunoassay, Parathyroid Hormone |
| Device description | The ELECSYS® Parathyroid Hormone Test System is based on a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. |
| | Results are determined usin a calibration curve that is generated specifically on each instrument by a 2-point calibration and a master curve provided with the reagent bar code. |

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| Intended use | For the quantitative determination of parathyroid hormone in human serum<br>and plasma. |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>use | For differential diagnosis of hypercalcemia and hypocalcemia. |
| Substantial<br>equivalence | The ELECSYS® Parathyroid Hormone Test System is equivalent to other<br>devices legally marketed in the United States. We claim equivalence to the<br>Nichols Intact Parathyroid Hormone (PTH) Immunoassay (K954418). |
| Substantial<br>equivalence -<br>similarities | The following table compares the ELECSYS® Parathyroid Hormone Test<br>System, with the predicate device. |

| Feature | ELECSYS® Parathyroid<br>Hormone Test System | Predicate Device |
|--------------------|---------------------------------------------------------------------|-----------------------------------------------------------------|
| Intended use | for the quantitative<br>determination of<br>parathyroid hormone | for the quantitative<br>determination of<br>parathyroid hormone |
| Indication for use | For differential diagnosis of<br>hypercalcemia and<br>hypocalcemia. | An aid in the assessment of<br>calcium metabolism<br>disorders. |
| Sample type | Human serum and plasma | Human serum and plasma |

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Substantial equivalence differences

The following table compares the ELECSYS® Parathyroid Hormone Test System, with the predicate device.

| Feature | ELECSYS® Parathyroid<br>Hormone Test System | Predicate Device |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Assay principle | Electrochemiluminescence<br>immunoassay employing<br>the sandwich principle. | Two-site<br>immunoradiometric assay<br>(IRMA) |
| Instrument | ELECSYS® 2010 and 1010<br>Immunassay analyzers | Gamma counter |
| Measuring range | 1.20-5000 pg/mL (0.127-<br>530 pmol/L) | 1.0pg/mL-highest calibrator |
| Expected values | 15-65 pg/mL (1.6-6.9<br>pmol/L) | 10-65 pg/mL |
| Traceability | Traceable to a<br>commercially available RIA<br>PTH test | No information in package<br>insert |
| Analytical<br>specificity | No detection of β -<br>CrossLaps, osteocalcin,<br>Human PTH-fragment 1-37<br>and bone-specific alkaline<br>phosphatase; | No detection of Human<br>PTH fragments 1-34, 39-68,<br>53-84, 44-68, and 39-84 |

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Substantial equivalence performance characteristics The performance characteristics of the ELECSYS® Parathyroid Hormone Test System and the predicate device are compared in the table below.

| Feature | ELECSYS® Parathyroid<br>Hormone Test System | Predicate Device |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Within-Run<br>precision (%CV) | 5.4% at 30.0 pg/mL<br>4.0% at 62.2 pg/mL<br>4.0% at 271 pg/mL<br>5.8% at 44.3 pg/mL<br>3.4% at 161 pg/mL<br>3.9% at 702 pg/mL | 3.4% at 40 pg/mL<br>1.8% at 266 pg/mL |
| Total precision<br>(%CV) | 5.9% at 30.0 pg/mL<br>4.3% at 62.2 pg/mL<br>4.3% at 271 pg/mL<br>7.1% at 44.3 pg/mL<br>5.0% at 161 pg/mL<br>5.4% at 702 pg/mL | 6.6% at 38 pg/mL<br>6.1% at 277 pg/mL |
| Analytical<br>sensitivity | 1.20 pg/mL | 1 pg/mL |

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Substantial equivalence performance characteristics, continued

The performance characteristics of the ELECSYS® Parathyroid Hormone Test System and the predicate device are compared in the table below.

| Feature | ELECSYS® Parathyroid<br>Hormone Test System | Predicate Device |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Limitations | No interference from<br>bilirubin up to 65 mg/dL No interference from<br>hemoglobin up to 1.5 g/dL No interference from<br>intralipid up to 1500<br>mg/dL No interference from<br>biotin up to 50 ng/mL No interference from<br>rheumatoid factor up to<br>1500 U/mL No high dose hook effect<br>up to 17,000 U/mL | No high dose hook effect<br>up to 100,000 pg/mL |
| Open vial<br>stability | Open vial - 12 weeks (2-8° C) | Reconstituted - 6 weeks<br>(2-8° C) |
| On-board<br>stability | ELECSYS® 2010: 8 weeks<br>ELECSYS® 1010: 4 weeks<br>(stored alternately in<br>refrigerator and analyzer at<br>ambient temperature 20-25 C)<br>Up to 20 hr. opened in total | NA |
| Calibration<br>frequency | ELECSYS® 2010:<br>After 1 month (same lot) after 7 days - same kit ELECSYS® 1010 with every reagent kit after 7 days (20-25° C) after 3 days (25-32° C) | Assay calibrators with<br>each run |

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SEP 2 8 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

Re: K992680

> Trade Name: ELECSYS® Parathyroid Hormone Test System Regulatory Class: II Product Code: CEW Dated: August 9, 1999 Received: August 10, 1999

Dear Ms. Hamill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):-NHA-

K992680

Device Name: ELECSYS® Parathyroid Hormone Test System

Indications For Use: For the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia.

San Cooper

(Division Sign Off)
Division of Clinical Laboratory Devices

1.80 K Upg 51 k) Number .

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | |
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| Over-The-Counter Use | |
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