ELECSYS PTH TEST SYSTEM

K070391 · Roche Diagnostics Corp. · CEW · Mar 20, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070391
• Device Name: ELECSYS PTH TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: CEW · Clinical Chemistry
• Decision Date: Mar 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended Use

The Elecsys PTH assay is an in vitro immunoassay for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on Roche Elecsys and cobas e analyzers.

Device Story

Elecsys PTH test system; immunoassay for quantitative intact PTH measurement in human serum/plasma. Modification: separation of 9-minute (Elecsys PTH STAT) and 18-minute (Elecsys PTH) application kits; expansion of 9-minute application to Elecsys 2010 and cobas e411 analyzers; reduction of hemoglobin interference limit from 1.5 g/dL to 0.25 g/dL. Used in clinical laboratory settings by trained technicians. Output: quantitative PTH concentration. Clinical decision-making: aids diagnosis/monitoring of parathyroid disorders. Benefit: faster turnaround time for STAT applications.

Clinical Evidence

Bench testing only. Design control activities, including FMEA and verification/validation testing, were performed to assess the impact of modifications (packaging, analyzer compatibility, and interference limit changes).

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection; streptavidin-coated microparticles; biotinylated capture antibody; ruthenium-labeled detection antibody. Analyzers: Elecsys 1010, 2010, cobas e 411, E170, cobas e 601. Sample: human serum/plasma (K3-EDTA). Calibration: 2-point calibration with master curve via reagent barcode.

Indications for Use

Indicated for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma to aid in the diagnosis and monitoring of patients with parathyroid disorders.

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

• Roche Elecsys PTH test system and Elecsys PTH CalSet (K992680)

Submission Summary (Full Text)

{0}------------------------------------------------

K07039/

| | 510(k) Summary - Elecsys PTH Test System |
|--|------------------------------------------|
|--|------------------------------------------|

MAR 2 0 2007

| 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<br>9115 Hague Rd<br>Indianapolis IN 46250<br>[phone] |
| | Contact person: Kay A. Taylor |
| | Date prepared: February 8, 2007 |
| Device name | |
| | Proprietary name: Elecsys PTH Immunoassay<br>Elecsys PTH CalSet |
| | Common name: Parathyroid Hormone Assay<br>Calibrator |
| | Classification name: Radioimmunoassay, Parathyroid Hormone<br>Calibrator, Secondary |
| Device description | (1) The Elecsys PTH STAT Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using 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.<br>(2) The Elecsys PTH STAT CalSet is a lyophilized product consisting of human serum with added synthetic PTH in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. |

.

{1}------------------------------------------------

| Intended use | (1) Immunoassay is for the in vitro quantitative determination of intact<br>parathyroid hormone in human serum and plasma for the differential<br>diagnosis of hypercalcemia and hypocalcemia.<br><br>(2) Used for calibrating the quantitative Elecsys PTH STAT assay for intact<br>PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay<br>analyzers. |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial<br>Equivalence | The Elecsys PTH STAT Test System (modified) is substantially equivalent to<br>other devices legally marketed in the United States. The Elecsys PTH STAT<br>Test System (modified) is equivalent to the Elecsys PTH System (K992680). |
| Device<br>Comparison | The following table compares the Elecsys PTH STAT Test System (modified)<br>and the predicate device. The predicate labeling used as the source document<br>for the comparison is from that provided to FDA in K961481/A003. |

#### Feature Predicate Device Modified Device Elecsys PTH Assay Elecsys PTH STAT 9 minute application Reagent Immunoassay for the in vitro Same Intended quantitative determination of intact Use/Indications parathyroid hormone in human for Use serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. Calibrator Elecsys PTH CalSet is used for Elecsys PTH CalSet STAT is used for Intended Use calibrating the quantitative Elecsys calibrating the quantitative Elecsys PTH PTH assay for intact PTH STAT assay for intact PTH (parathyroid (parathyroid hormone) on the hormone) on the Elecsys and cobas e Elecsys immunoassay analyzers immunoassay analyzers Platform(s) Elecsys 1010, Elecsys 2010, Elecsys 1010, Elecsys 2010, cobas e 411 MODULAR ANALYTICS E170, analyzers cobas e 411 and cobas e 601 analyzers.

### Comparison Table

{2}------------------------------------------------

| Comparison Table | | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Predicate Device<br>Elecsys PTH Assay | Modified Device<br>Elecsys PTH STAT<br>9 minute application |
| Assay Protocol | Sandwich assay | Same |
| Detection | Electrochemiluminescent | Same |
| Total Assay<br>Duration | Elecsys 1010: 9 minute application<br>Elecsys 2010, cobas e 411 E170,<br>and cobas e 601: 18 minute<br>application | 9 minute application only |
| Sample Type | Human serum and plasma treated<br>with K3-EDTA. | Same |
| Calibrator | Elecsys PTH CalSet | Elecsys PTH STAT CalSet |
| CalSet Levels | Two | Same |
| Measuring<br>Range | 1.20 – 5,000 pg/mL | Same |
| Analytical<br>sensitivity | 1.20 pg/mL<br>(0.127 pmol/L) | Same |
| CalSet Matrix | Human serum w/ synthetic PTH | Same |
| CalSet Storage | Lyophilized | Same |
| CalSet Target<br>Conc. | Cal 1: ~0.05 pg/mL<br>Cal 2: ~4500 pg/mL | Same |
| Traceability /<br>Standardization | Standardized against a<br>commercially available PTH test<br>(RIA). | Standardized against Elecsys PTH (Cat.<br>No. 11972103). This in turn was<br>Standardized against a commercial PTH<br>test (RIA). |
| Hook Effect | No high dose hook effect at PTH<br>concentrations up to 17,000 pg/mL. | Same |
| Analytical<br>Specificity | For the monoclonal antibodies used,<br>the following cross-reactivities were<br>found: Osteocalcin, PTH fragment<br>1-37, bone-specific alkaline<br>phosphatase, and β-Crosslaps: no<br>cross-reactivity detectable. | Same – reworded to be more clear<br><br>No cross-reactivities were found for:<br>Osteocalcin, PTH fragment 1-37,<br>bone-specific alkaline phosphatase, and<br>β-CrossLaps. |
| Comparison Table | | |
| Feature | Predicate Device<br>Elecsys PTH Assay | Modified Device<br>Elecsys PTH STAT<br>9 minute application |
| Reagent Stability | Unopened:<br>2-8°C -- Up to the stated expiration date<br>Opened:<br>2-8°C – 12 weeks<br>On the E170/cobas e 601 and<br>Elecsys 2010/cobas e 411:<br>8 weeks<br>On the Elecsys 1010:<br>4 weeks (stored alternately in the<br>refrigerator and on the analyzer- ambient temperature 20-25°C; up to 20 hours opened in total.) | Same<br><br>Opened:<br>2-8°C – 12 weeks<br>On Elecsys 2010/cobas e 411: 8 weeks<br>On the Elecsys 1010:<br>4 weeks (stored alternately in the refrigerator and on the analyzer- ambient temperature 20-25°C; up to 20 hours opened in total.) |
| Calibration<br>Interval | Calibration must be performed once per reagent lot using fresh reagent (i.e. not more than 24 hours since the reagent kit was registered on the analyzer). | Same |
| Calibration<br>Interval,<br>continued | Renewed calibration is recommended as follows:<br>E170/cobas e 601 and Elecsys 2010/cobas e 411:<br>After 1 month (28 days) when using the same reagent lot.<br>After 7 days (when using the same reagent kit on the analyzer).<br><br>Elecsys 1010:<br>With every reagent kit.<br>After 7 days (20-25°C).<br>After 3 days (25-32°C). | Elecsys 2010/cobas e 411:<br>After 1 month (28 days) when using the same reagent lot.<br>After 7 days (when using the same reagent kit on the analyzer).<br><br>Elecsys 1010:<br>With every reagent kit.<br>After 7 days (20-25°C).<br>After 3 days (25-32°C). |
| Feature | Predicate Device<br>Elecsys PTH Assay | Modified Device<br>Elecsys PTH STAT<br>9 minute application |
| Precision | Elecsys 1010/ 2010:<br>Within-run<br>5.4% CV @ 30.0 pg/mL<br>4.0% CV @ 62.2 pg/mL<br>4.0% CV @ 271 pg/mL<br>5.8% CV @ 44.3 pg/mL<br>3.4% CV @ 161 pg/mL<br>3.9% CV @ 702 pg/mL<br><br>Total<br>5.9% CV @ 30.0 pg/mL<br>4.3% CV @ 62.2 pg/mL<br>4.3% CV @ 271 pg/mL<br>7.1% CV @ 44.3 pg/mL<br>5.0% CV @ 161 pg/mL<br>5.4% CV @ 702 pg/mL<br><br>E170:<br>Within-run<br>2.0% CV @ 25.0 pg/mL<br>1.2% CV @ 39.8 pg/mL<br>1.1% CV @ 139 pg/mL<br>2.2% CV @ 82.2 pg/mL<br>2.8% CV @ 265 pg/mL<br>0.6% CV @ 1,215 pg/mL<br><br>Total<br>3.4% CV @ 26.4 pg/mL<br>2.5% CV @ 91.5 pg/mL<br>2.8% CV @ 269 pg/mL<br>1.7% CV @ 82.7 pg/mL<br>1.6% CV @ 267 pg/mL<br>1.6% CV @ 1,222 pg/mL | Elecsys 1010:<br>Same<br><br>Same<br><br>Elecsys 2010/cobas e411<br>Within-run<br>2.1% CV @ 53.4 pg/mL<br>1.7% CV @ 215 pg/mL<br>1.7% CV @ 980 pg/mL<br>1.6% CV @ 52.6 pg/mL<br>2.0% CV @ 182 pg/mL<br>1.8% CV @ 744 pg/mL<br><br>Total<br>3.8% CV @ 53.4 pg/mL<br>2.8% CV @ 215 pg/mL<br>2.5% CV @ 980 pg/mL<br>1.9% CV @ 52.6 pg/mL<br>2.5% CV @ 182 pg/mL<br>2.2% CV @ 744 pg/mL<br><br>E170:<br>Not applicable |
| Feature | Predicate Device<br>Elecsys PTH Assay | Modified Device<br>Elecsys PTH STAT<br>9 minute application |
| Limitations | The assay is unaffected by:<br>Icterus (bilirubin <1,112 µmol/L or <65 mg/dL,<br>Hemolysis (Hb < 0.932 mmol/L or < 1.5 g/dL),<br>Lipemia (Intralipid < 1,500 mg/dL)<br>Biotin (<205 nmol/L or < 50 ng/mL)<br>No interference was observed from rheumatoid factors up to a concentration of 1,500 IU/mL In patients receiving therapy with high biotin doses (i.e > 5 mg/day), no sample should be taken until at least 8 hours after the last biotin administration In vitro tests were performed on 16 commonly used pharmaceuticals. No interference with the assay was found. As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been tested with monoclonal mouse antibodies or have received them for diagnostic purposes. In rare cases, interference due to extremely high titers of antibodies to ruthenium can occur. | Same except,<br>Hemolysis (Hb < 0.155 mmol/L or < 0.25 g/dL; do not analyze samples that show visible signs of hemolysis) |
| Feature | Predicate Device<br>Elecsys PTH Assay | Modified Device<br>Elecsys PTH STAT<br>9 minute application |
| Limitations,<br>continued | As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. In rare cases, interference due to extremely high titers of antibodies to ruthenium can occur. The test contains additives which minimize these effects. Extremely high titers of antibodies to streptavidin can occur in isolated cases and cause interference. For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical exam and other findings | Same |

#### mparison Tahle ﺮ ﺍﻟﻤﺮﺍﺟﻊ

.

{3}------------------------------------------------

:

{4}------------------------------------------------

______________________________________________________________________________________________________________________________________________________________________________

——

#### mnarison Tahla ﺗ

{5}------------------------------------------------

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{6}------------------------------------------------

:

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Roche Diagnostics Corp. Ms. Kay Taylor, MT (ASCP), RAC 9115 Hague Road Indianapolis, IN 46250-0457

MAR 2 0 2007

k070391 Trade/Device Name: Elecsys Parathyroid Hormone Test System Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Codes: CEW, JIT Dated: March 05, 2007 Received: March 06, 2007

Dear Ms. Taylor:

Re:

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 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 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).

{8}------------------------------------------------

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Jéan M. Cooper, M.S., 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

{9}------------------------------------------------

## Indications for Use

510(k) Number (if known): K070391

Device Name: Elecsys PTH Test System

Indications For Use:

### Elecsys PTH Immunoassay (18 minute application) Elecsys PTH STAT Immunoassay (9 minute application)

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

The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

### Elecsys PTH STAT CalSet

Elecsys PTH CalSet STAT is used for calibrating the quantitative Elecsys PTH STAT assay for intact PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay analyzers.

### Elecsys PTH CalSet

Elecsys PTH CalSet is used for calibrating the quantitative Elecsys PTH assay for intact PTH (parathyroid hormone) on the Elecsys and cobas e immunoassay analyzers

Prescription Use XXXX (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)

Division Sign-Off

Office of In Vitro Diagnostic Device

Evaluation and Safety

| | Page 1 of 1 |
|--|-------------|
|--|-------------|

c070391

25