VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY

K983031 · Ortho-Clinical Diagnostics, Inc. · LOJ · Dec 18, 1998 · Immunology

Device Facts

• Record ID: K983031
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAY
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: LOJ · Immunology
• Decision Date: Dec 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

VITROS AFP Reagent Pack - For the in vitro quantitative measurement of alpha-fetoprotein (AFP) in human serum to aid in the management of patients with non-seminomatous testicular cancer. VITROS AFP Calibrators - For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of AFP in human serum.

Device Story

VITROS AFP assay is an in vitro diagnostic test for quantitative measurement of alpha-fetoprotein (AFP) in human serum. Used as an aid in managing patients with non-seminomatous testicular cancer. System utilizes coated microwells as solid phase separation and luminescence as signal detection. Input is human serum sample (25 µL); processed via automated VITROS Immunodiagnostic System instrumentation. Assay involves two 16-minute incubations at 37°C with shaking. Employs sheep polyclonal anti-AFP antibody (biotinylated) and mouse monoclonal anti-AFP antibody (enzyme-labeled). Output is quantitative AFP concentration (IU/mL or ng/mL). Used in clinical laboratory settings by trained personnel. Results assist clinicians in monitoring disease progression or treatment response in testicular cancer patients.

Clinical Evidence

Clinical performance evaluated using samples from serially monitored patients diagnosed and treated for testicular cancer. Comparison to predicate device via Deming's Regression showed correlation coefficient of 0.991. Additional testing included analytical sensitivity, specificity, precision, dilution, and expected values in healthy individuals, cancer patients, and patients with non-malignant diseases. Results showed distribution patterns paralleling expected clinical outcomes.

Technological Characteristics

Solid-phase immunoassay using coated microwells. Detection via luminescence. Reagents include biotinylated sheep polyclonal anti-AFP and enzyme-labeled mouse monoclonal anti-AFP. Sample volume: 25 µL. Incubation: 2x 16 minutes at 37°C. Automated instrumentation (VITROS Immunodiagnostic System).

Indications for Use

Indicated for in vitro quantitative measurement of alpha-fetoprotein (AFP) in human serum to aid in the management of patients with non-seminomatous testicular 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

• Abbott AxSYM System AFP (P820060S8)

Submission Summary (Full Text)

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VITROS AFP assay

#### ADMINISTRATIVE 1

#### 510(k) Summary 1.1

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: 1983031

## 1. Submitter name, address, contact

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

Contact Person: Charles Morganson

Date 510(k) prepared: August 27, 1998

### 2. Device Name

Trade or Proprietary Name: VITROS Immunodiagnostic Products AFP assay Common Name: Alpha-Fetoprotein assay Classification Name: Alpha-Fetoprotein test kit for testicular cancer

## 3. Predicate Device

The VITROS Immunodiagnostic Products AFP assay is substantially equivalent to the Abbott AxSYM System AFP (P820060S8).

#### 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. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

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

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).

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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 AFP assay is intended for the in vitro quantitative measurement of albhafetoprotein (AFP) in human serum, to aid in the management of patients with non-seminomatous testicular cancer.

### 6. Comparison to Predicate Device

The VITROS Immunodiagnostic Products AFP assay is substantially equivalent to Abbott AxSYM System AFP (predicate device), which was approved by FDA (P820060S8) for IVD use.

The relationship between the VITROS AFP assay and the predicate device, determined by Deming's Regression, is:

VITROS AFP assay = 0.889 x [AxSYM AFP assay] + 2.60 (IU/mL), with a correlation coefficient of 0.991.

Comparisons of the VITROS AFP assay and the predicate device were performed with samples from serially monitored patients diagnosed and treated for testicular cancer.

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

Table 1 lists the similarities and differences of the device characteristics between the VITROS AFP assay with the predicate device. Abbott AxSYM AFP assay:

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Table 1 List of the assay characteristics

| Device<br>Characteristic | VITROS AFP assay | Predicate<br>Device |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Calibration range | 0 - 500 IU/mL (1st IRP<br>72/225)<br>0 - 520 ng/mL | 0 - 350 ng/mL |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | VITROS<br>Immunodiagnostic System | Abbott AxSYM System |
| Sample type | Serum | Serum, plasma (heparin, citrate or EDTA) |
| Antibody | 1) Sheep polyclonal anti-<br>AFP antibody in<br>biotinylated antibody<br>reagent<br><br>2) Mouse monoclonal anti-<br>AFP antibody in conjugate<br>reagent | 1) mouse monoclonal<br>anti-AFP antibody coated<br>onto microparticles<br><br>2) mouse monoclonal<br>anti-AFP antibody in<br>conjugate |
| Sample volume | 25 µL | 150 µL |
| Incubation time and<br>temperature | First incubation 16<br>minutes at 37°C with<br>shaking<br>Second incubation 16<br>minutes at 37°C with<br>shaking | Details not listed in<br>package insert |

## 7. Conclusions

The data presented in the premarket notification demonstrate that the VITROS AFP assay performs substantially equivalent to the predicate device, for which there is an approved PMA.

Equivalence was demonstrated using currently commercially available reagents along with patient specimens covering the normal, therapeutic and diagnostic range. In clinical studies of apparently healthy individuals, patients with cancer and patients with a variety of non-malignant diseases, the VITROS AFP assay exhibited distribution results that parallel expected distributions for these patient types.

The serial monitoring study demonstrated the clinical utility of the VITROS AFP assay as an aid in the management of patients with non-seminomatous testicular cancer.

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

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2098 Gaither Road Rockville MD 20850

Food and Drug Administration

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of an eagle or bird, with three curved lines forming its body and wings. The logo is in black and white.

# DEC 18 1998

Ortho-Clinical Diagnostics, Inc. C/O Mr. Charles Morganson, Jr. Requlatory Affairs Associate Requlatory Affairs MC00882 100 Indigo Creek Drive Rochester, New York 14626

K983031 Re:

> Vitros Immunodiagnostic Products AFP Reagent Pack Trade Name: Regulatory Class: Product Code: LOJ Dated: Auqust 27, 1998 Received: August 31, 1998

Dear Mr. Morqanson:

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 reqistration, 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 Requlations, 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 Requlation (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 obliqation 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

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 requlation 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 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 -

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#### 1 .3 Indications For Use Statement

## Page 1 of 1

| 510(k) Number (if known): | K983031 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Immunodiagnostic Products AFP Reagent Pack<br>VITROS Immunodiagnostic Products AFP Calibrators |
| Indications for Use: | VITROS AFP Reagent Pack - For the in vitro quantitative<br>measurement of alpha-fetoprotein (AFP) in human serum to aid<br>in the management of patients with non-seminomatous testicular<br>cancer. |
| | VITROS AFP Calibrators - For in vitro use in the calibration of<br>the VITROS Immunodiagnostic System for the quantitative<br>measurement of AFP in human serum. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K983031 |

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">OR</div> | Over-The-Counter Use |
|------------------------------------------|------------------------------------------|----------------------|
| <div>✓</div> | | |

(Optional Format 1-2-96)