VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK

K984289 · Ortho-Clinical Diagnostics, Inc. · LTJ · Mar 12, 1999 · Immunology

Device Facts

• Record ID: K984289
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT PACK
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: LTJ · Immunology
• Decision Date: Mar 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

The Vitros® PSA is an in vitro assay intended for the quantitative measurement of prostate specific antigen (PSA) in human serum or plasma (EDTA or heparin) to aid in the management of patients with prostate cancer.

Device Story

VITROS PSA assay is an in vitro diagnostic test for quantitative measurement of prostate specific antigen (PSA) in human serum or plasma. The device utilizes the VITROS Immunodiagnostic System, which employs luminescence as a signal for detection. The system uses coated microwells as a solid phase separation system. The assay involves two mouse monoclonal anti-PSA antibodies in a biotinylated reagent and a goat polyclonal anti-PSA antibody in a conjugate reagent. The system automates the immunoassay process, providing quantitative results to clinicians. These results aid in the management of patients with prostate cancer, including serial monitoring of patients previously treated for the disease. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Clinical performance was evaluated by comparing the VITROS PSA assay to the predicate device using patient specimens from normal individuals, patients with malignant disease, and patients with non-malignant diseases. Results showed distribution patterns paralleling expected clinical outcomes. A serial monitoring study confirmed equivalence in patients previously treated for prostate cancer. Analytical performance metrics included analytical sensitivity (0.02 ng/mL), precision, and dilution studies. Regression analysis against the predicate yielded a correlation coefficient of 0.989.

Technological Characteristics

Solid phase immunoassay using luminescence signal detection. Employs coated microwells as solid phase. Reagents include two mouse monoclonal anti-PSA antibodies (biotinylated) and goat polyclonal anti-PSA antibody (conjugate). Sample volume: 15 uL. Analytical sensitivity: 0.02 ng/mL. Calibration range: 0-100 ng/mL. System is automated via VITROS Immunodiagnostic System instrumentation.

Indications for Use

Indicated for the quantitative measurement of prostate specific antigen (PSA) in human serum or plasma (EDTA or heparin) to aid in the management of patients with prostate cancer.

Regulatory Classification

Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Predicate Devices

• Hybritech Tandem®-R PSA (P850048)

Submission Summary (Full Text)

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#### ADMINISTRATIVE 1

#### 1.1 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is: K984889

### 1. Submitter name, address, contact

Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 [phone]

Contact Person: Anne Zavertnik

Date 510(k) prepared: November 30, 1998

### 2. Device Name

Trade or Proprietary Name: VITROS® Immunodiagnostic Products PSA Calibrators VITROS® Immunodiagnostic Products PSA Reagent Pack

Common Name: PSA assay

Classification Name: test for the in vitro quantitative determination of prostate specific antigen in serum or plasma.

## 3. Predicate Device

The VITROS Immunodiagnostic Products PSA assay is substantially equivalent to the Hybritech Tandem®-R PSA (P850048).

# 4. Device Description

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma or urine. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

- 1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products PSA Reagent Pack, VITROS Immunodiagnostic Products PSA Calibrators, which are combined by the VITROS Immunodiagnostic System to perform the VITROS PSA assay).

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- 2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).
- 3. Common reagents used by the VITROS System in each assay. The VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 510(k) pre-market notification (K984310).

The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.

## 5. Device Intended Use

The Vitros® PSA is an in vitro assay intended for the quantitative measurement of prostate specific antigen (PSA) in human serum or plasma (EDTA or heparin) to aid in the management of patients with prostate cancer.

## 6. Comparison to Predicate Device

The VITROS Immunodiagnostic Products PSA assay is substantially equivalent to Hybritech Tandem-R PSA (predicate device), which was approved by FDA (P850048) for IVD use.

The relationship between the VITROS PSA assay and the predicate device, determined by Bablock Passing, is:

VITROS PSA assay = 1.028 x [the Tandem-R PSA assay] -- 0.089 (ng/mL), with a correlation coefficient of 0.989.

Comparisons of the VITROS PSA assay and the predicate device were performed with samples from a variety of clinical categories.

In addition to the studies mentioned above, tests were performed to obtain analytical sensitivity, specificity, precision, dilution and expected values. Refer to the VITROS PSA assay package insert for VITROS PSA assay results.

Table 1 lists the similarities and differences of the device characteristics between the VITROS PSA assay with the predicate device:

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| Device<br>Characteristic | VITROS PSA assay | Predicate<br>Device |
|--------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Calibration range | 0 - 100 ng/mL | 0 - 100 ng/mL |
| Basic principle | Solid phase immunoassay | Solid phase<br>immunoradiometric assay |
| Sample type | Serum, plasma (heparin or<br>EDTA) | Serum |
| Antibody | l) Two mouse monoclonal<br>anti-PSA antibodies in<br>biotinylated antibody<br>reagent | l) Mouse monoclonal<br>anti-PSA antibody coated<br>onto plastic beads |
| | 2) Goat polyclonal anti-<br>PSA antibody in conjugate<br>reagent | 2) Radiolabeled mouse<br>monoclonal anti-PSA in<br>protein matrix |
| Sample volume | 15 uL | 50 uL |
| Analytical sensitivity | 0.02 ng/mL | 0.1 ng/mL |

Table 1 List of the assay characteristics

# 7. Conclusions

The data presented in the premarket notification demonstrate that the VITROS PSA assay performs substantially equivalent to the approved predicate device.

Equivalence was demonstrated using currently commercially available reagents along with patient specimens from patients who are normal, undergoing therapeutic and/or undergoing diagnostic evaluation. In clinical studies of apparently healthy individuals, patients with malignant disease and patients with a variety of non-malignant diseases, the VITROS PSA assay exhibited distribution results that parallel expected distributions for these patient types.

The serial monitoring study demonstrated that the VITROS PSA assay is substantial equivalent to the predicate device in patients previously treated for prostate cancer.

The data presented in the premarket notification provide a reasonable assurance that the VITROS PSA assay is safe and effective for the stated intended use.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized figures that appear to be birds or abstract human figures. The figures are arranged in a vertical stack, with the top figure being the largest and the bottom figure being the smallest.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 2 1999

Anne Zavertnik Regulatory Affairs Associate Ortho-Clinical Diagnostics 100 Indigo Creek Drive Rochester NY 14626-5101

Re: K984289

> Trade Name: VITROS Immunodiagnostic Products PSA Calibrators VITROS Immunodiagnostic Products PSA Reagent Pack Regulatory Class: II Product Code: LTJ Dated: February 26, 1999 Received: March 1, 1999

Dear Ms. Zavertnik:

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 QS 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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## Page 2

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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Autman

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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Page 1 of 1

# 1.2 Indications For Use Statement

510(k) Number (if known):

Device Name:

VITROS Immunodiagnostic Products PSA Reagent Pack VITROS Immunodiagnostic Products PSA Calibrators

1484289

Indications for Use:

The Vitros® PSA is an in vitro assay intended for the quantitative measurement of prostate specific antigen (PSA) in human serum or plasma (EDTA or heparin) to aid in the management of patients with prostate cancer.

Tita E. Makeri
(Division Sign Off)

(Division Sign-Off) (Division Sign of Clinical Laboratory Dev 84289 510(k) Number

(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)