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

Indications for 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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SPECIAL 510(k): Device Modification
OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: K041322

VITROS Immunodiagnostic Products CEA Reagent Pack, Calibrators and Range Verifiers

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: VITROS Immunodiagnostic Products CEA Reagent Pack, Calibrators and Range Verifiers (k990943 and k990984)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED (page 12) along with the proposed labeling which includes instructions for use, package labeling.

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:
- a change in the number of calibrators from 3 to 2;
- calibrator #1 target value changed from 5 ng/mL to 3 ng/mL;
- change in calibrator and range verifiers formulation from current base matrix (liquid BSA) to newborn calf serum; and
- change in preservative in the calibrators and range verifiers from 2% Proclin 300 to 2% Kathon in the calibrators and range verifiers

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device included in addition to the changes listed in #3, labeling, intended use, and calibration range, sample type, antibodies, method principle, tracer, instrumentation, sample volume and incubation time and temperature.

5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis (pages 18 and 19). The risk analysis method used to assess the impact of the device modifications was a Failure Modes and Effects Analysis (FMEA).
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied (pages 18 and 19).
c) A declaration of conformity with design controls. The declaration of conformity should include:

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i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met (page 10), and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review (page 11).

6. A Truthful and Accurate Statement, a 510(k) Summary and the Indications for Use Enclosure.

The labeling for the modified subject devices has been reviewed to verify that the indication/intended use statements for the devices are unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the devices be determined substantially equivalent to the previously cleared devices.

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