IMMULITE 2500 OM-MA, MODEL L5KOP

K072794 · Siemens Medical Solutions Diagnostics · LTK · Nov 5, 2007 · Immunology

Device Facts

• Record ID: K072794
• Device Name: IMMULITE 2500 OM-MA, MODEL L5KOP
• Applicant: Siemens Medical Solutions Diagnostics
• Product Code: LTK · Immunology
• Decision Date: Nov 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

The IMMULITE 2500 OM-MA is intended for in vitro diagnostic use with the IMMULITE 2500 analyzer - for the quantitative measurement of CA125 antigen in serum, as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer, and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures.

Device Story

The IMMULITE 2500 OM-MA is a solid-phase, two-site, chemiluminescent immunometric assay designed for use on the IMMULITE 2500 Automated Analyzer. It processes human serum samples to measure CA125 antigen levels. The analyzer performs the immunochemical reaction and detects chemiluminescent signals to quantify the antigen concentration. Used in clinical laboratory settings by trained technicians, the output provides quantitative data to clinicians. This information assists in monitoring therapeutic response and detecting residual disease in epithelial ovarian cancer patients, potentially guiding clinical decisions regarding second-look diagnostic procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on analytical performance comparisons between the subject device and the predicate.

Technological Characteristics

Solid-phase, two-site, chemiluminescent immunometric assay. Designed for use on the IMMULITE 2500 Automated Analyzer. In vitro diagnostic reagent system.

Indications for Use

Indicated for quantitative measurement of CA125 antigen in human serum to monitor therapy response in patients with epithelial ovarian cancer and to detect residual disease in patients post-first-line therapy considered for second-look procedures.

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

• Immulite 2000 OM-MA (K983391)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K072794

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

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) Immulite 2000 OM-MA (K983391)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

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 _the addition of a new instrument family member (Immulite 2500) and change in assay incubation time_

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and analytical performance characteristics

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 Modified Failure Mode Effects and Criticality Analysis (FMECA)

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

c) A declaration of conformity with design controls. The declaration of conformity should include:

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, 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.

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

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modifications 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 device be determined substantially equivalent to the previously cleared (or their preamendment) device.