CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS

K050202 · Beckman Coulter, Inc. · CGR · Feb 9, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050202
• Device Name: CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
• Applicant: Beckman Coulter, Inc.
• Product Code: CGR · Clinical Chemistry
• Decision Date: Feb 9, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1205
• Device Class: Class 2

Intended Use

The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in serum, plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

Device Story

Access Cortisol reagent system; utilizes rabbit anti-cortisol polyclonal antibody in R1b component; performs quantitative cortisol measurement in serum, plasma, and urine; used in clinical laboratory settings on Access Immunoassay Systems; provides diagnostic data for cortisol levels; modification involves new manufacturing lot of polyclonal antibody; fundamental scientific technology remains unchanged; clinical utility unaffected by antibody lot change.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and analytical performance comparisons.

Technological Characteristics

In vitro diagnostic immunoassay reagent; utilizes rabbit anti-cortisol polyclonal antibody; designed for use on Access Immunoassay Systems; fundamental technology unchanged from predicate; labeling updated for analytical specificity/interference and expected values for urine concentration.

Indications for Use

Indicated for the quantitative determination of cortisol in human serum, plasma, and urine on the Access Immunoassay Systems.

Regulatory Classification

Identification

A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

Predicate Devices

• Access Cortisol Assay Beckman Coulter, Inc. (k954733)

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 K050202

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.) k954733
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 a new manufacturing lot of rabbit anti-cortisol polyclonal antibody utilized in the R1b component of the Access Cortisol reagents.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics. Labeling changes were made in association with the above listed modification in the Analytical Specificity/Interference section and the Expected value section for urine concentration using extracted and unextracted methods. Also one editorial change was the removal of the reference to "step 1 of Procedure section" in the Procedural comment section.

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
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 or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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(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 device be determined substantially equivalent to the previously cleared (or their preamendment) device.