ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY

K020217 · Bayer Diagnostics Corp. · JJX · Mar 15, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020217
• Device Name: ACS:180 AND ADVIA CENTAUR IPTH IMMUNOASSAY
• Applicant: Bayer Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The ACS:180 and ADVIA Centaur Intact PTH Immunoassay is intended for the quantitative determination of intact parathyroid hormone in human EDTA plasma on the automated analyzers marketed by Bayer Corporation. Measurements of intact PTH levels are used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.

Device Story

Two-site sandwich immunoassay; uses chemiluminometric technology. Input: human EDTA plasma samples. Process: sample incubated with Lite Reagent (LR) containing N-terminal (1-34) acridinium ester-labeled antibody and C-terminal (39-84) biotin-labeled antibody; immuno-complex captured by streptavidin-coated paramagnetic particles in Solid Phase (SP) reagent; unbound conjugates washed away. Output: relative light units (RLUs) measured in luminometer; signal directly proportional to intact PTH concentration. Used in clinical laboratories on automated analyzers (ACS:180 or ADVIA Centaur). Operated by laboratory technicians. Results used by physicians to aid in differential diagnosis of parathyroid-related disorders.

Clinical Evidence

Method comparison study using 100 EDTA plasma samples (range 5.4–1969 pg/mL) compared the ACS:180 iPTH to the predicate Nichols IRMA kit, yielding a correlation coefficient (r) of 0.985 and linear regression y = 0.976x - 17. A separate transference study compared ADVIA Centaur iPTH to ACS:180 iPTH using 268 samples (range 9.3–1981 pg/mL), yielding r=0.994.

Technological Characteristics

Two-site sandwich immunoassay; chemiluminometric detection using acridinium ester-labeled antibody and biotin-labeled antibody; streptavidin-coated paramagnetic particles for solid-phase capture. Automated analyzer platform. Replaces manual radiolabeled antibody method with chemiluminogenic label. Incubation time 7.5 minutes.

Indications for Use

Indicated for the quantitative determination of intact parathyroid hormone in human EDTA plasma to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH) kit / Nichols IRMA Intact PTH (K954418)

Submission Summary (Full Text)

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

# MAR 1 5 2002

#### Bayer Diagnostics ASC:180 Intact Parathyroid Hormone (iPTH) Immunoassay Section 2: Summary of Safety and Effectiveness

K020217

This Summary of Safety and Effectiveness has been prepared in accordance with the requirements of 21 CFR 807.92.

#### 1. Submitter Information

| Contact person: | Kenneth T. Edds, Ph.D. |
|------------------------|-------------------------------------------------------------------------------|
| Address: | Bayer Diagnostics Corporation<br>511 Benedict Ave.<br>Tarrytown, NY 10591 |
| | Phone: [phone]<br>FAX: [phone]<br>e-mail: [e-mail] |
| Date Summary Prepared: | January 9, 2002 |

2. Device Information

| Proprietary Name: | ACS:180 and ADVIA Centaur Intact PTH<br>Immunoassay |
|-------------------|-----------------------------------------------------|
| Common Name: | iPTH |
| Classification: | immunological test system |

Classification: Class: CFR: Product Code:

immunological test system Class II Device 21 CFR 862.1545 CEW

### 3. Predicate Device Information

Name:

Manufacturer:

Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH) kit / Nichols IRMA Intact PTH

Nichols Institute Diagnostics 33608 Ortega Highway San Juan Capistrano, Ca

510(k) Number:

K954418

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

#### 4. Device Description

The ACS:180 Intact PTH assay is a two-site "sandwich" immunoassay using direct, chemiluminometric technology, which uses two affinity purified goat polyclonal antibodies specific for the PTH molecules. The first antibody is directed toward the N-terminal (1-34) antigenic PTH domain and is labeled with acridinium ester (AE). The second antibody is directed toward the C-terminal (39-84) antigenic domain and is labeled with biotin. Patient sample (calibrator or control material) is incubated, for 5 minutes at 37°C with the Lite Reagent (LR) material that contains both the capture and tracer antibody conjugates. An immuno-complex is formed between the intact PTH in the sample and the two antibody conjugates. Subsequently, Solid Phase (SP) reagent is added and incubated for 2.5 minutes at 37°C. The immuno-complex molecule is captured by the streptavidim coated paramagnetic particles in the SP. Following incubation the unbound antibody conjugates are washed away. The chemiluminescent of the immuno-complex signal is measured in a luminometer. A sample with low intact PTH will have a minimum amount of bound AE label, while samples containing high levels of intact PTH will have maximum label complex bound. Thus, a direct relationship exists between the amount of intact PTH present in the sample and the amount of relative light units (RLUs) detected by the system.

#### 5. Statement of Intended Use

The ACS:180 and ADVIA Centaur Intact PTH Immunoassay is intended for the quantitative determination of intact parathyroid hormone in human EDTA plasma on the automated analyzers marketed by Bayer Corporation. Measurements of intact PTH levels are used to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.

#### 6. Summary of Technological Characteristics

The ACS:180 Intact PTH immunoassay is similar to the predicate device Nichols IRMA Intact PTH Assay Kit in the assay principles and performance characteristics. The ACS:180 Intact PTH immunoassay differs from the predicate device in its intended use on an automated analyzer as compared to a manual coated tube technique. In the automated method a chemiluminogenic (acridinium ester) labeled antibody replaces the radiolabeled antibody in the manual method. The automated method also offers a shorter incubation time, 7.5 minutes compared to 22 hours.

#### 7. Method Comparison

The data represented in this document is organized into two components:

- 1. Comparison of the ACS:180 iPTH to the predicate device Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH) kit (K954418) results in section 4.
- Comparison of the ADVIA Centaur to the ACS:180 used transference. Transference is a method 2. recommended by NCCLS (C28-A, How to Define Reference Intervals in the Clinical Laboratory; Approved Guideline). This document discusses and provides guidelines for "transference of s reference interval for an analyte measured by a different analytical system, different method or different instrument. Results are in section 5.

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

# ACS:180 iPTH vs. Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH)

Substantial equivalence to the Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH) kit, cleared under K954418, is based on method comparison using 100 EDTA plasma samples in the range of 5.4 to 1969 pg/mL. The results using a linear regression are listed below:

y (ACS:180) = 0.976 x (Nichols IRMA) - 17 pg/mL Correlation coefficient ( r ) = 0.985 N = 100 Sy.x = 66

### ADVIA Centaur iPTH vs. ACS:180 iPTH

For 268 EDTA plasma samples in the range of 9.3 to 1981 pg/mL, the relationship between the ADVIA Centaur iPTH assay and the ACS:180 iPTH assay is described by the equation:

:

ADVIA Centaur iPTH = 1.03 (ACS:180 iPTH) + 3.36 pg/mL Correlation Coefficient ( r ) = 0.994 N = 252 Sy = 31

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

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 5 2002

Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

Re: k020217

Trade/Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur Intact PTH Assay Regulation Number: 21 CFR 862.1545; 21 CFR 862.1660; 21 CFR 862.1150 Regulation Name: Parathyroid hormone test system; Quality control Material (assayed and unassayed); Calibrator Regulatory Class: Class II; Class I, Class II Product Code: CEW; JJX; JIT Dated: January 18, 2002 Received: January 22, 2002

Dear Dr. Edds:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave and have 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 for ass stated in the encreat , 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 -

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 notification. The IDA inding of succeantly of 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 CFF Part 801 and 1 If you desire specific advice for your as ic devices), please contact the Office of Compliance at additionally 809.10 for in vito diagnostions on the promotion and advertising of your device, [phone]. Traditionally, 2011 proce at [phone]. Also, please note the regulation prease connact the Ornov or Somphises researce to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionals and Consumer Assistance at its toll-free number [phone] or Manufacturers International and Solasss "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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

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

Page i

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Bayer Diagnostics ACS:180 and ADVIA Centaur Intact PTH Assay

## Indications for Use:

The ACS:180 and ADVIA Centaur Intact PTH Immunoassay is intended for the quantitative determination of intact parathyroid hormone in human EDTA plasma on the automated ACS:180 and decemmation or maor paradifiere net.Raver Corporation. Intact PTH levels can be used to aide in the All VIA Cenada analyzolo marketed of Bosn, hypoparathyroidism, or hypercalcemia of malignancy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

OR

| Over-The-Counter Use<br>(Optional Format 1-2-96) | |
|--------------------------------------------------|--|
|--------------------------------------------------|--|

(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K020217 |
|---------------|---------|
|---------------|---------|