ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647

K072612 · Beckman Coulter, Inc. · MOI · Oct 26, 2007 · Immunology

Device Facts

• Record ID: K072612
• Device Name: ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
• Applicant: Beckman Coulter, Inc.
• Product Code: MOI · Immunology
• Decision Date: Oct 26, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

The Access BR Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 15-3 antigen to aid in the management of breast cancer patients. Serial testing for patient CA 15-3 antigen concentrations should be used in conjunction with other clinical methods for monitoring breast cancer. The Access BR Monitor Calibrators are intended to calibrate the Access BR Monitor assay for the quantitative determination of CA 15-3 antigen levels in human serum and plasma using the Access Immunoassay Systems.

Device Story

Access BR Monitor is a two-site immunoenzymatic (sandwich) assay for CA 15-3 antigen quantification in human serum and plasma. System utilizes paramagnetic particles as solid support and chemiluminescent substrate for detection. Operated on Access Immunoassay Systems; intended for clinical laboratory use. Input is patient serum/plasma sample; output is quantitative CA 15-3 concentration (U/mL). Healthcare providers use serial measurements to monitor breast cancer management alongside other clinical methods. Modification to original device involved updating imprecision specifications for concentrations >500 U/mL.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to assess impact of assay imprecision modifications. Results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Two-site immunoenzymatic (sandwich) immunoassay. Solid support: paramagnetic particles. Detection: chemiluminescent substrate. Analytical range: 0.5-1000 U/mL. Calibrators: six levels (0, 10, 50, 100, 500, 1000 U/mL) in buffered BSA matrix.

Indications for Use

Indicated for use as an in vitro diagnostic assay for the quantitative measurement of CA 15-3 antigen in human serum and plasma to be used as an aid in the management of patients with breast 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

• Beckman Coulter Access BR Monitor (K033036)

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 K072612

This 510(k) submission contains information/data on modifications made to the SUBMITTERS 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 SUBMITTERS previously cleared device. (For a preamendments device, a statement to this effect has been provided.) Beckman Coulter Access BR Monitor (k033036)
2. Submitters 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, users 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 changes in assay imprecision.
4. Comparison Information (similarities and differences) to applicants legally marketed predicate device including, labeling, intended use, physical characteristics, and performance information on the change in imprecision.
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 (Failure Mode Effects Analysis)
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 modification 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.