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The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (TPOAb) levels in human serum and plasma using the Access Immunoassay Systems. The detection of TPOAb is an aid in the diagnosis of thyroid autoimmune disorders.

The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (TPO Ab) levels in human serum and plasma using the Access Immunoassay Systems. The Access TPO Antibody Calibrators are intended to calibrate the Access TPO Antibody assay for the quantitative determination of TPO Antibody levels in human serum and plasma using the Access Immunoassay Systems. The Access TPO Antibody assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with paramagnetic particles coated with thyroperoxidase protein. The serum or plasma TPO Ab binds to the thyroperoxidase. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.

The Access Thyroglobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goter, and Graves' disease.

The Access Thyroqlobulin Antibody II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of Hashimoto's disease, nontoxic goiter, and Graves' disease. The Access Thyroglobulin Antibody II assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffers. The assay is run on Access 2 Immunoassay Analyzers. The device modifications described in this submission impact the Access Thyroqlobulin Antibody II reagent pack only; they do not impact or change the other components that are used with this reagent pack. The modification does not affect the intended use or indications of the device or alter the fundamental scientific technology of the device. A description of the reagent pack is provided below. | Well | Ingredients | |------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | R1a: | Dynabeads* paramagnetic particles coated with streptavidin and<br>coupled to biotinylated human thyroglobulin, suspended in a TRIS<br>buffer with protein (bovine), < 0.1% sodium azide, and 0.1%<br>ProClin** 300. | | R1b: | Human thyroglobulin-alkaline phosphatase (bovine) conjugate in a<br>TRIS buffer with protein (bovine), < 0.1% sodium azide, and 0.1%<br>ProClin 300. | | R1c: | TRIS buffer with protein (bovine), < 0.1% sodium azide and 0.1%<br>ProClin 300. | | R1d: | TRIS buffer with blocking polymer, < 0.1% sodium azide and 0.1%<br>ProClin 300. |

Immunoassay for the in vitro quantitative determination of antibodies to thyroglobulin in human serum and plasma. The anti-Tg autoantibodies determination is used as an aid in the detection of autoimmune thyroid diseases in conjunction with other laboratory and clinical findings. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzer.

The Elecsys Anti-Tg immunoassay makes use of a competitive test principle using biotinylated human antigen and monoclonal human anti-Tg antibodies labeled with a ruthenium complex. The Elecsys Anti-Tg immunoassay is intended for the quantitative determination of antibodies to thyroglobulin in human serum and plasma. It is intended for use on the cobas e immunoassay analyzers. Results are determined via a calibration curve which is instrument-specifically generated by 2 point calibration and a master curve provided via the reagent barcode or e barcode.

Immunoassay for the in vitro quantitation of autoantibodies to thyroid stimulating hormone (TSH) receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients suspected of Graves' disease (autoimmune hyperthyroidism). The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e 601 immunoassay analyzers.

The Elecsys Anti-TSHR is used for the in vitro quantitative determination of autoantibodies to TSHR receptor in human serum using a human thyroid stimulating monoclonal antibody. It is intended for use on the cobas e 601 immunoassay analyzer. The cobas e family of analyzers uses electrochemiluminescence immunoassay "ECLIA" technology.

EliA anti-TG Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroglobulin (TG) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TG uses the EliA IgG method on the instrument Phadia 250. EliA anti-TG Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroglobulin (TG) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TG uses the EliA IgG method on the instrument Phadia 2500/5000. EliA anti-TPO Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroid peroxidase (TPO) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TPO uses the EliA IgG method on the instrument Phadia 250. EliA anti-TPO Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroid peroxidase (TPO) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TPO uses the EliA IgG method on the instrument Phadia 2500/5000. EliA Thyroid Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies against thyroid peroxidase (TPO) and thyroglobulin (TG) with Phadia 250 using the EliA IgG method. EliA Thyroid Positive Control 2500/5000 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies against thyroid peroxidase (TPO) and thyroglobulin (TG) with Phadia 2500/5000 using the EliA IgG method.

The method specific reagents on Phadia® 250 and Phadia® 2500/5000 are identical: they are only filled in different containers. Each device consists of: - EliA anti-TG wells are coated with a human thyroglobulin antigen 4 carriers (16 wells each), ready to use; or EliA anti-TPO wells are coated with a human recombinant thyroid peroxidase - antigen 4 carriers (16 wells each), ready to use; EliA Sample Diluent: PBS containing BSA, detergent and 0.095% sodium azide - 6 bottles, 48 mL each, ready to use; or 6 bottles, 400 mL each, ready to use; - -EliA IgG Conjugate 50 or 200: ß-Galactosidase labeled anti-IgG (mouse monoclonal antibodies) in PBS containing BSA and 0.06% sodium azide - 6 wedge shaped bottles, 5 mL each, ready to use; or 6 wedge shaped bottles, 19 mL each, ready to use - -EliA Thyroid Positive Control 250 or 2500/5000: Human serum containing IqG antibodies to TG and TPO in PBS containing BSA, detergent and 0.095% sodium azide - 6 single use vials, 0.3 mL each, ready to use; - EliA Negative Control 250 or 2500/5000: Human sera from healthy donors in -PBS containing BSA, detergent and 0.095% sodium azide - 6 single-use vials, 0.3 mL each, ready to use; - -EliA IgG Calibrator Strips: Human IqG (0, 4, 10, 20, 100, 600 µq/L) in PBS containing BSA, detergent and 0.095% sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use; - -EliA IgG Curve Control Strips: Human IgG (20 µg/L) in PBS containing BSA, detergent and 0.095% sodium azide - 5 strips, 6 single-use vials per strip, 0.3 mL each, ready to use; - -EliA IqG Calibrator Well: Coated with mouse monoclonal antibodies - 4 carriers (12 wells each), ready to use. The Phadia EliA Immunodiagnostic System is an automated system for immunodiagnostic testing. The EliA reagents are available as modular packages, each purchased separately. All packages except the positive and negative controls are required to carry out an EliA anti-TG or anti-TPO test.

The IMMULITE® 2000 TSI (thyroid-stimulating immunoglobulins) Assay is an in vitro diagnostic immunoassay for the semi-quantitative determination of thyroid stimulating autoantibodies specific to thyroid stimulating hormone receptors (TSHR) in human serum (including Serum Separator tubes) or plasma (K2-EDTA or lithium heparin). The IMMULITE® 2000 TSI Assay is for use on the IMMULITE® 2000 system. The measurement of thyroid stimulating autoantibodies, in conjunction with other clinical and laboratory findings, is used as an aid in the diagnosis of patients suspected of having Graves' disease. The IMMULITE® TSI Calibration Verification Material (CVM) is for in vitro diagnostic use in the verification of calibration of the IMMULITE® TSI Assay on the IMMULITE® 2000 Systems.

The IMMULITE 2000 TSI assay kit consists of the following components: - TSI bead pack coated with MAb (3D7) anti-TSHR anchor antibody and hTSHR Capture Chimera - TSI reagent wedge containing hTSHR-Chimera alkaline phosphatase conjugate - TSI adjustors: low and high, containing TSI negative heat-inactivated bovine serum and thyroid stimulating human MAb (M22) - TSI controls: negative, low, and high, containing TSI negative human serum and thyroid stimulating MAb (M22) - Multi-Diluent 2

The Thyretain ™ TSI Reporter BioAssay is intended for the qualitative detection in serum of thyroid stimulating autoantibodies to the thyroid stimulating hormone (TSH) receptors (TSHRs) on the thyroid. The detection of these stimulating autoantibodies, in conjunction with other clinical and laboratory findings, may be useful as an aid in the differential diagnosis of patients with Graves' disease (GD).

The number of wells tested per Positive, Reference and Negative control has been reduced from three to two for each. The number of wells tested per patient specimen has been reduced from three to two.

The TheraTest EL-Anti-TPO™ is an enzyme immunoassay for the qualitative detection or quantitative determination of IgG class antibodies against thyroid peroxidase (TPO) in human serum. The TheraTest EL-Anti-TPO™ assay is intended for use as an aid in the diagnosis of autoimmune thyroid disorders in conjunction with other clinical and laboratory findings. The TheraTest EL-Anti-Thyroglobulin™ is an enzyme immunoassay for the qualitative detection or quantitative determination of IgG class antibodies against thyroglobulin in human serum. The TheraTest EL-Anti-ThyroglobulinTM assay is intended for use as an aid in the diagnosis of autoimmune thyroid disorders in conjunction with other clinical and laboratory findings.

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The Thyretain ™ TSI Reporter BioAssay is intended for the qualitative detection in serum of thyroid stimulating autoantibodies to the thyroid stimulating hormone (TSH) receptors (TSHRs) on the thyroid. The detection of these stimulating autoantibodies, in conjunction with other clinical and laboratory findings, may be useful as an aid in the differential diagnosis of patients with Graves' disease (GD).

The Thyretain ™ TSI Reporter BioAssay (TSI Reporter) utilizes a patented bioassay technology to detect thyroid stimulating immunoglobulin (TSI) in human serum. Genetically engineered Chinese hamster ovary (CHO) cells, expressing a chimeric form' of the human thyroid stimulating hormone receptor (TSHR) and a cyclic adenosine monophosphate (cAMP) induced luciferase reporter gene, are cryogenically preserved and provided in measured aliquots. The CHO Mc4 cell line has a nucleic acid sequence encoding a chimeric human TSH receptor, designed for reduced response to thyroid blocking immunoglobulin (TBI) activity. Thus, the hTSH receptor, comprised of 730 amino acids, has amino acid residues 262 to 335 replaced by the equivalently located 73 amino acid residues of the rat Luteinizing Hormone receptor to form the chimeric TSHR. This chimeric receptor is linked to a firefly luciferase reporter gene in operable combination with a glycoprotein hormone a-subunit promoter. The cells are seeded and grown for 15 to 18 hours to confluent monolayers in a 96-well plate. Patient sera, reference control, positive and normal controls and are diluted with a proprietary reaction buffer (RB), added to the cell monolayers and allowed to react with the cells for 3 hours. During this induction period TSI, if present in the patient serum, bind to the chimeric human TSHR on the cell surface. This binding event induces a signaling cascade resulting in increased production of intra-cellular cAMP. This increased production of cAMP is evidenced by increased production of luciferase. At the conclusion of the 3 hour induction period the cells are lysed. Luciferase levels are then measured using a luminometer. A significant increase in luminescence over the Reference Control indicates the presence of TSI antibodies in the sample.

(1) Elecsys Anti-TSHR immunoassay: Immunoassay for the in vitro quantitative determination of autoantibodies to TSH receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients with suspect Graves' disease (autoimmune hyperthyroidism). The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. (2) Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR immunoassay on the Elecsys and cobas e immunoassay analyzers.

(1) The Elecsys Anti-TSHR immunoassay is a three step competition principle immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. (2) The Elecsys PreciControl ThyroAB is a lyophilized product consisting of human serum with added Anti-TSHR antibody (human) in two concentration ranges. During manufacture, the antibody is spiked into the matrix at the desired concentration levels. Note: The reagent and quality control material are packaged separately.