ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET

K052982 · Roche Diagnostics · JIT · Oct 28, 2005 · Clinical Chemistry

Device Facts

• Record ID: K052982
• Device Name: ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET
• Applicant: Roche Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Oct 28, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Elecsys Prolactin II CalSet is used for the calibration of the Elecsys Prolactin assay on the Elecsys and cobas e immunoassay analyzers.

Device Story

The cobas Elecsys Prolactin II CalSet is a secondary calibrator used to calibrate the quantitative Elecsys Prolactin II assay on Elecsys immunoassay systems. The device consists of a lyophilized buffered equine serum matrix containing recombinant prolactin at two concentration levels (low and high). It is intended for professional use in clinical laboratory settings. By providing known concentration values, the calibrator allows the immunoassay system to establish a calibration curve, enabling the accurate quantification of prolactin in patient samples. This process ensures the analytical performance of the assay, supporting clinical decision-making related to prolactin levels.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized buffered equine serum matrix; contains recombinant prolactin; two concentration levels (approx. 2 µIU/mL and 2,000 µIU/mL); standardized to 3rd IRP WHO Reference Standard 84/500; intended for use on Elecsys immunoassay systems.

Indications for Use

Indicated for the calibration of the Elecsys Prolactin assay on Elecsys and cobas e immunoassay analyzers.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Elecsys Prolactin CalSet (K964748)

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 K052982

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.)
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 Elecsys Prolactin II CalSet (previously Prolactin CalSet) to change to a buffered equine serum as the matrix (from the original buffer/protein matrix) and to change to a lyophilized storage form (from the original liquid storage).

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, levels, stability, storage form, and matrix.
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.