ROCHE ELECSYS ANTI-TG

K053426 · Roche Diagnostics Corp. · JZO · Feb 7, 2006 · Immunology

Device Facts

• Record ID: K053426
• Device Name: ROCHE ELECSYS ANTI-TG
• Applicant: Roche Diagnostics Corp.
• Product Code: JZO · Immunology
• Decision Date: Feb 7, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Indications for Use

Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg determination is used as an aid in the detection of autoimmune thyroid diseases. The electrochemiluminescence Immunoassay “ECLIA” is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

Device Story

The Elecsys Anti-Thyroglobulin (Anti-Tg) Antibody Test System is an in vitro diagnostic assay used to measure anti-Tg antibodies in human serum and plasma. The device utilizes an electrochemiluminescence immunoassay (ECLIA) principle. Modifications to the predicate device include changing the calibrator form from liquid to lyophilized, adjusting reagent stability claims to six weeks, increasing the monoclonal anti-Tg antibody concentration in Reagent 2, and correcting the source of Anti-Tg antibodies in Calibrator 2. The device is intended for use by laboratory professionals. The output provides quantitative antibody levels, which assist clinicians in the assessment of thyroid-related conditions. The modifications do not alter the fundamental scientific technology of the assay.

Clinical Evidence

Bench testing only. The submission relies on design control activities, risk analysis, and verification/validation testing to demonstrate that modifications to the calibrators and reagents do not affect the performance or intended use of the device.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection; streptavidin microparticles; ruthenium-labeled monoclonal anti-Tg antibodies. Analyzers: Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170. Calibrators are lyophilized. Reagents and controls have harmonized stability claims.

Indications for Use

Indicated for the in vitro quantitative determination of anti-thyroglobulin antibodies in human serum and plasma.

Regulatory Classification

Identification

A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

Predicate Devices

• Elecsys Anti-Tg (K020672)

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 k053426

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. ELECSYS® Anti-Thyroglobulin (Anti-Tg) Antibody Test System (k020672)
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

1. Correct a typographical error of the source of the Anti-Tg antibodies in Cal 2 from human to sheep.
2. Change calibrator form from liquid to lyophilized.
3. Change the stability claims for calibrators to 6 weeks (2-8 °C) upon reconstitution.
4. Change the stability claims for all other reagents and controls to 6 weeks (2-8 °C) to harmonize to that of the calibrators.
5. Change the filling volume of the calibrators from 1.3 ml to 1.5 ml.
6. Change concentration of monoclonal anti-Tg antibodies (human) labeled with ruthenium complex from 0.52 mg/L to 0.62 mg/L.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, traceability/standardization, test principle, measuring range, and limitations:

| Item | K020672 (Predicate) | Modified Device |
| --- | --- | --- |
| Calibrators | Liquid | Lyophilized |
| Stability (Opened)
Reagents (M, R1, R2)
PC-A-Tg1, PC-A-Tg2 | up to twelve weeks, 2-8 °C
up to eight weeks, 2-8 °C | up to six weeks, 2-8 °C.
six weeks, 2-8 °C |
| Reagent 2 (R2) | 0.520 mg/L | 0.620 mg/L |
| Cal2 source | Typographical error listed as human | Sheep |
| Package Insert | | |
| Precautions and warnings | | Avoid the formation of foam with all reagents and sample types (specimens, calibrators, and controls). |
| Specimen collection and preparation | | The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in |

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2

| Item | K020672 (Predicate) | Modified Device |
| --- | --- | --- |
| | | some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer. |
| Calibration verification | Not necessary. The analyzer's software automatically checks the validity of the curve and draws attention to any deviations. | Deleted |
| Expected Values | | Reference to brochure "Reference Intervals for Children and Adults" added |
| References | | #5 added
#9 (data on file at Roche) deleted |
| "Limited License" & "Limited Warranty" | | Added |

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. (See "Risk Analysis Results," in Section IV, pg. 32-33.)

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. (See "Summary of Risk Analysis," in Section IV, pg. 31.)

c) A declaration of conformity (See Section IV, pg. 34) 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. (See Section II, pg. 22-23 & Section III, pg. 25)

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.