VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS

K041322 · Ortho-Clinical Diagnostics, Inc. · DHX · Jun 17, 2004 · Immunology

Device Facts

• Record ID: K041322
• Device Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK/CALIBRATOR/RANGE VERIFIERS
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: DHX · Immunology
• Decision Date: Jun 17, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

VITROS Immunodiagnostic Products CEA Reagent Pack For in vitro diagnostic use only. The VITROS CEA Reagent Pack quantitatively measures carcinoembryonic antigen (CEA) concentration in human serum and plasma to aid in the prognosis and management of cancer patients in whom changing concentrations of CEA are observed. VITROS Immunodiagnostic Products CEA Calibrators For in vitro use in the calibration of the VITROS Immunodiagnostic System for the quantitative measurement of CEA in serum and plasma (EDTA or heparin). VITROS Immunodiagnostic Products CEA Range Verifiers For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of CEA.

Device Story

The VITROS Immunodiagnostic System is an automated laboratory instrument for semi-quantitative immunoassay analysis. It utilizes coated microwells as a solid-phase separation system. The device processes human serum or plasma samples (20μL) using a mouse monoclonal anti-CEA antibody (biotinylated) and an enzyme-labeled tracer. The system performs a 30-minute incubation at 37°C, followed by luminescence-based signal detection. The system is operated by laboratory personnel in a clinical setting. The output is a quantitative CEA concentration value, which clinicians use to monitor disease progression or treatment response in cancer patients. The system integrates reagent packs, calibrators, and range verifiers to ensure measurement accuracy within a 0 to 400 ng/mL range.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing, design control activities, and risk analysis (FMEA) demonstrating that modifications did not alter the fundamental scientific technology or performance characteristics of the device.

Technological Characteristics

Solid-phase immunoassay using luminescence detection. Instrumentation: VITROS Immunodiagnostic System. Reagents: Mouse monoclonal anti-CEA antibody (biotinylated), enzyme-labeled tracer. Calibrators/Verifiers: New Born Calf Serum matrix with Kathon preservative. Sample volume: 20μL. Incubation: 30 minutes at 37°C. Calibration range: 0-400 ng/mL.

Indications for Use

Indicated for the quantitative in vitro determination of carcinoembryonic antigen (CEA) in human serum and plasma to aid in the management of cancer patients.

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

• VITROS Immunodiagnostic Products CEA Reagent Pack, Calibrators and Range Verifiers (k990943)
• VITROS Immunodiagnostic Products CEA Reagent Pack, Calibrators and Range Verifiers (k990984)

Submission Summary (Full Text)

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#### JUN 1 7 2004

### Section 1: Summary Information 510(k) Summary

This summary of 510(k) safety and effectiveness information is being This Summary of 510(tr) Sales) a requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K041332

- Ortho-Clinical Diagnostics, Inc. 1. Submitter Mail Stop 881 name, address, 100 Indigo Creek Drive contact Rochester, New York 14626-5101 [phone]
Sarah CV Parsons, RAC Contact Person:

- Date Special 510(k) prepared: May 17, 2004 Preparation 2. date
- Trade or Proprietary Name: 3. Device
- VITROS Immunodiagnostic Products CEA Reagent Pack name VITROS Immunodiagnostic Products CEA Calibrator VITROS Immunodiagnostic Products CEA Range Verifiers

: VITROS CEA assay Common Name Classification Name: Tumor associated antigen immunological test system (21 CFR 866.6010).

- The VITROS Immunodiagnostic Products CEA Reagent Pack, VITROS 4. Predicate Immunodiagnostic Products CEA Calibrators (new formulation) and VITROS device Immunodiagnostic Products CEA Range Verifiers (new formulation) are substantially equivalent to the VITROS Immunodiagnostic Products CEA Reagent Pack and VITROS Immunodiagnostic Products CEA Calibrators (original formulation) and VITROS Immunodiagnostic Products CEA Range Verifiers (original formulation).
Continued on next page

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### 510(k) Summary, Continued

- The VITROS Immunodiagnostic System uses luminescence as the signal in 5. Device The TITCOS intitutive and semi-quantitative determination of selected analytes in description the qualititude to and believe and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:

- The VITROS Immunodiagnostic Products range of immunoassay . products (in this case VITROS Immunodiagnostic Products CEA Reagent Pack, VITROS Immunodiagnostic Products CEA Calibrators (both cleared under K990943), and VITROS Immunodiagnostic (bodi ctoal CEA Range Verifiers (K990984) which are combined by the VITROS Immunodiagnostic System to perform the VITROS CEA 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).
- Common reagents used by the VITROS System in each assay include . the VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent which were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

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

Continued on next page

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## 510(k) Summary, Continued

.

| 6. Device<br>intended<br>use | VITROS Immunodiagnostic Products CEA Reagent Pack<br>For in vitro diagnostic use only.<br>The VITROS CEA Reagent Pack quantitatively measures carcinoembryonic<br>antigen (CEA) concentration in human serum and plasma to aid in the<br>prognosis and management of cancer patients in whom changing<br>concentrations of CEA are observed. |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | VITROS Immunodiagnostic Products CEA Calibrators<br>For in vitro use in the calibration of the VITROS Immunodiagnostic System<br>for the quantitative measurement of CEA in serum and plasma (EDTA or<br>heparin). |
| | VITROS Immunodiagnostic Products CEA Range Verifiers<br>For in vitro use in verifying the calibration range of the VITROS<br>Immunodiagnostic System when used for the measurement of CEA. |
| 7. Comparison<br>to predicate<br>device | The VITROS Immunodiagnostic Products CEA Reagent Pack, the VITROS<br>Immunodiagnostic Products CEA Calibrators (new formulation) and the<br>VITROS Immunodiagnostic Products CEA Range Verifiers (new formulation)<br>are substantially equivalent to VITROS Immunodiagnostic Products CEA<br>Reagent Pack and VITROS Immunodiagnostic Products CEA Calibrators<br>(K990943) and VITROS Immunodiagnostic Products CEA Range Verifiers<br>(K990984) cleared by the FDA for in vitro diagnostic use. |
| | Table 1 lists the characteristics of the VITROS CEA assay (new formulation)<br>and the VITROS CEA Assay (original formulation). |

Continued on next page

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### 510(k) Summary, Continued

| Device<br>Characteristic | Predicate Device<br>VITROS CEA assay<br>(Current) | New Device<br>VITROS CEA assay<br>(Modified) |
|--------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Number of Calibrators | 3 | 2 |
| Nominal Calibrator values | 0, 5 and 250 ng/mL | 3 & 250 ng/mL |
| Calibration range | 0 to 400 ng/mL | 0 to 400 ng/mL |
| Sample type | Serum and plasma (EDTA or<br>heparin). | Serum and plasma (EDTA or<br>heparin). |
| Antibody | Mouse monoclonal anti-CEA<br>antibody in biotinylated<br>antibody reagent | Mouse monoclonal anti-CEA<br>antibody in biotinylated<br>antibody reagent |
| Base Matrix: Calibrators and<br>Range Verifiers | Liquid BSA | New Born Calf Serum |
| Preservative: Calibrators and<br>Range Verifiers | Proclin | Kathon |
| Basic principle | Solid phase immunoassay | Solid phase immunoassay |
| Tracer | Enzyme labeled | Enzyme labeled |
| Instrumentation | VITROS Immunodiagnostic<br>System | VITROS Immunodiagnostic<br>System |
| Sample volume | 20μL | 20μL |
| Incubation time and<br>temperature | 30 minutes at 37°C | 30 minutes at 37°C |

### Table 1 List of Assay Characteristics: Comparison to Predicate Device

- The information presented in the pre-market notification demonstrates that the 8. Conclusions performance of the VITROS Immunodiagnostic Products CEA assay (new formulation) is substantially equivalent to the cleared predicate device.
Equivalent performance was demonstrated using manufactured reagents, positive and negative controls and testing human samples near the low end of the assay range.

The information presented in the premarket notification provide a reasonable assurance that the VITROS CEA Assay is safe and effective for the stated intended use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three parallel lines forming its body and wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. The text is in uppercase letters and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Sarah Parsons, RAC Regulatory Affairs Associate Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101

JUN 1 7 2004

k041322 Re:

Trade/Device Name: VITROS Immunodiagnostic Products CEA Reagent Pack VITROS Immunodiagnostic Products CEA Calibrators VITROS Immunodiagnostic Products CEA Range Verifiers Regulation Number: 21 CFR § 866.6010 Regulation Name: Carcinoembryonic Antigen (CEA) Immunological Test System Regulatory Class: II Product Code: DHX, JJX Dated: May 17, 2004 Received: May 18, 2004

Dear Ms. Parsons:

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). 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.

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Page 2

If you desire specific information about the application of labeling requirements to your device, IT you desire specific mornitures as advertising of your device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the vitro Diagnounding by reference to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the Tou may oount other geleral missational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker Jr.

Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Statement of Intended Use

Page 1 of 1

| 510(k) Number (if known): | K041322 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | VITROS Immunodiagnostic Products CEA Reagent Pack<br>VITROS Immunodiagnostic Products CEA Calibrators<br>VITROS Immunodiagnostic Products CEA Range Verifiers |
| Indications for Use: | VITROS Immunodiagnostic Products CEA Reagent Pack<br>For in vitro diagnostic use only.<br>The VITROS CEA Reagent Pack quantitatively measures<br>carcinoembryonic antigen (CEA) concentration in human serum<br>and plasma to aid in the prognosis and management of cancer<br>patients in whom changing concentrations of CEA are observed.<br>VITROS Immunodiagnostic Products CEA Calibrators<br>For in vitro use in the calibration of the VITROS<br>Immunodiagnostic System for the quantitative measurement of<br>CEA in serum and plasma (EDTA or heparin).<br>VITROS Immunodiagnostic Products CEA Range Verifiers<br>For in vitro use in verifying the calibration range of the VITROS<br>Immunodiagnostic System when used for the measurement of<br>CEA. |

Prescription Use _____________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21CFR807 Subpart C) (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety

| 510(k) | K041322 |
|--------|---------|
|--------|---------|

Ortho-Clinical DiagnosticsPage 7 of 56

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Ortho-Clinical Dragnostic Products CEA Reagent Pack, Calibrator, Range Verifier