IMMUNOCAP THYRLOBULIN IMMUNOCAP

K072661 · Phadia US, Inc. · JNL · Nov 20, 2007 · Immunology

Device Facts

• Record ID: K072661
• Device Name: IMMUNOCAP THYRLOBULIN IMMUNOCAP
• Applicant: Phadia US, Inc.
• Product Code: JNL · Immunology
• Decision Date: Nov 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5870
• Device Class: Class 2

Indications for Use

ImmunoCAP Thyrodlobulin is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin (TG) in human serum and plasma. ImmunoCAP Thyroglobulin is intended to be used with the ImmunoCAP 100° and ImmunoCAP 250 instruments. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis and Graves' disease, and is to be used in clinical laboratories, as well as physicians office laboratories. ImmunoCAP Thyroid Peroxidase is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroid Peroxidase (TPO) in human serum and plasma. ImmunoCAP Thyroid Peroxidase is intended to be used with the ImmunoCAP 100C and ImmunoCAP 250 instruments. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis, Graves' disease and is to be used in clinical laboratories, as well as physicians office laboratories. ImmunoCAP Thyroglobulin IgG Antibodies Controls NLH are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of specific IgG Thyroglobulin antibodies in human serum. ImmunoCAP Thyroglobulin IgG Antibodies Controls are intended to be used with the instrument ImmunoCAP 100° and ImmunoCAP 250. ImmunoCAP Thyroid Peroxidase IgG Antibodies Controls NLH are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of specific IgG Thyroid Peroxidase antibodies in human serum. ImmunoCAP Thyroid Peroxidase IgG Antibodies Controls are intended to be used with the instrument ImmunoCAP 100€ and ImmunoCAP 250.

Device Story

ImmunoCAP Thyroglobulin and Thyroid Peroxidase ImmunoCAP are in vitro diagnostic assays for detecting IgG antibodies. Modifications include rebranding from UniCAP to ImmunoCAP, updated sample diluent containing a blocking agent to reduce non-specific binding, and expanded compatibility for use on both ImmunoCAP 100 and ImmunoCAP 250 instruments. The system utilizes automated immunoassay technology to measure antibody levels in patient samples. Results are used by clinicians to aid in the diagnosis of thyroid-related autoimmune conditions. The device provides quantitative outputs compared against established cut-off values to categorize results as normal, equivocal, or positive.

Clinical Evidence

Validation study performed with n=100 samples for both Thyroglobulin and TPO assays. Results established new expected values and cut-offs: Thyroglobulin normal <280 IU/mL, equivocal 280-344 IU/mL, positive >344 IU/mL; TPO normal <60 IU/mL, equivocal 60-100 IU/mL, positive >100 IU/mL. Comparison made against predicate device data (n=60).

Technological Characteristics

Non-competitive solid phase fluorescence-immunoassay (EIA). Conjugate: mouse anti-human IgG beta-galactosidase. Substrate: 4-Methylumbelliferyl-ßD-Galactoside. Fully automated system (ImmunoCAP 100/250). Calibration: six WHO-standardized IgG calibrators; curve stored up to 28 days. Software-based result evaluation.

Indications for Use

Indicated for in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin (TG) or Thyroid Peroxidase (TPO) in human serum/plasma to aid in diagnosis of autoimmune thyroiditis and Graves' disease. Used in clinical/physician office laboratories.

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

• UniCAP Thyroglobulin (k981559)
• UniCAP Thyroid Peroxidase (k981930)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum

To: THE FILE

RE: k072661

ImmunoCAP™ Thyroglobulin ImmunoCAP

ImmunoCAP™ Thyroid Peroxidase ImmunoCAP

Autoimmunity Specific IgG Sample Diluent

ImmunoCAP™ Thyroglobulin IgG Antibodies Controls NLH

ImmunoCAP™ Thyroglobulin ImmunoCAP

ImmunoCAP™ Thyroid Peroxidase IgG Antibodies Controls NLH

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. UniCAP Thyroglobulin (k981559) and UniCAP Thyroid Peroxidase (k981930)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED (page 4) along with the proposed labeling which includes instructions for use, package labeling.
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.

The change involves the following:

- Change of product name from UniCAP to ImmunoCAP
- Change sample diluent which contains a blocking agent that binds unspecific binding antibodies
- Option to use ImmunoCAP 100 as well as ImmunoCAP 250

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device included the following:

| Topic | ImmunoCAP™ Thyroglobulin ImmunoCAP
ImmunoCAP™ Thyroid Peroxidase
ImmunoCAP
Autoimmunity Specific IgG Sample Diluent
ImmunoCAP™ Thyroglobulin IgG
Antibodies Controls NLH
ImmunoCAP™ Thyroid Peroxidase IgG
Antibodies Controls NLH | UniCAP Thyroglobulin (k981559)
UniCAP Thyroid Peroxidase (k981930) |
| --- | --- | --- |
| Format | Thyroglobulin and Thyroid peroxidase controls
NLH sold separately | Sample diluent and controls are kit components |
| Expected values (Data of Validation study included) | ImmunoCAP Thyroglobulin
(n=100) <280 IU/mL
ImmunoCAP TPO
(n=100) <60 IU/mL | UniCAP Thyroglobulin
(n=60) <220 IU/mL
UniCAP TPO
(n=60) <24 IU/mL |
| Suggested Cut-off | ImmunoCAP Thyroglobulin
Normal <280 IU/mL
Equivocal Zone 280-344 IU/mL
Positive >344 IU/mL
ImmunoCAP TPO
Normal <60 IU/mL
Equivocal Zone 60-100 IU/mL
Positive >100 IU/mL | UniCAP Thyroglobulin
Normal <172 IU/mL
Equivocal Zone 172-344 IU/mL
Positive >344 IU/mL
ImmunoCAP TPO
Normal <60 IU/mL
Equivocal Zone 60-100 IU/mL
Positive >100 IU/mL |
| Conversion Factor | Included in software | UniCAP Thyroglobulin |

{1}

2

| | | 1 mg_{A}/L = 86 IU/mL
UniCAP TPO
1 mg_{A}/L = 10 IU/mL |
| --- | --- | --- |

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. The risk analysis method used to assess the impact of the device modification was *Failure Mode and Effect Analysis (FMEA)* procedure (Pages 1-8)

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 attachment).

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 (page 38) 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 (page 38).

5. 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 modifications 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 device.