ELECSYS TSH CALSET W/MODELS 04738551

K060754 · Roche Diagnostics Corp. · JIT · Apr 18, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060754
• Device Name: ELECSYS TSH CALSET W/MODELS 04738551
• Applicant: Roche Diagnostics Corp.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Elecsys TSH CalSet is used for calibrating the quantitative Elecsys TSH assay on the Elecsys immunoassay analyzers.

Device Story

Elecsys TSH CalSet; calibrator set for TSH immunoassays; used in clinical laboratory settings by laboratory professionals. Input: equine serum matrix (Cal 1) and human serum matrix with added human TSH (Cal 2). Output: calibration values for TSH assay quantification. Modification: transition from recombinant yeast-derived TSH to human-derived TSH; increased open-vial stability claim. Device supports clinical decision-making by ensuring accurate TSH measurement for thyroid function assessment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Calibrator set consisting of equine serum matrix (Cal 1) and human serum matrix with added human TSH (Cal 2). Used for immunoassay calibration. Stability claim increased for open-vial usage.

Indications for Use

Indicated for the calibration of quantitative Elecsys TSH assays on Elecsys immunoassay analyzers. No specific patient population, age, or disease state contraindications are defined for this calibrator product.

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 TSH CalSet (K961491)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K060754 Roche Diagnostics Corp.
ELECSYS TSH CALSET W/ MODELS 04738551

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.
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: The Elecsys TSH CalSet (modified) consists of equine serum matrix (Cal 1) and a human serum matrix with added human TSH (Cal 2) in two concentration ranges. The predicate device contained added recombinant (yeast-derived) TSH. The modified device has an increased open-vial stability claim.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, immunoassay technology, test protocol, performance, assay principle, cutoff level and reagents.

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.