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The PersonallAB™ Automated Micropiate Analyzer from BloCHEM IMMUNOSYSTEMS (U. S.), INC. of Allentown Pennsylvania is a fully automated microplate analyzer. The analyzer is used for the in vitro diagnostic processing of human and animal specimens with Immunoenzymatic techniques, developed on 96 well microplate formats, such as:

• E.I.A. (Enzyme Immuno Assay), and
• E.L.I.S.A. (Enzyme Linked Immuno Sorbent Assay).

The PersonalLAB™ Automated Microplate Analyzer is intended to duplicate the manual analytical procedures associated to an assay and the assay's reagents, by performing automatically the various steps identified in the assay manufacturer's Instructions For Use. The steps performed are as follows:

• Specimen handling and identification,
• Specimen pipetting and pre-dilution,
• Reagent distribution and pipetting.
• Washing of the microplates.
• Incubation of the microplates,
• Photometric reading of the microplates,
• Data analysis -- both quantitative and qualitative,
• Data management - displaying, printing and archiving, and
• Waste management.

The PersonalLAB™ Automated Microplate Analyzer is used for the in vitro diagnostic processing of various specimen types, as define by the assay manufacturer's instructions for use. Examples of specimen types are as follows:

• Whole blood,
• Serum.
• Plasma.
• Urine,
• Stool.
• Spinal fluid,
• Saliva, and
• Swabs from antigen sites.

The PersonallAB™ Automated Micropiate Analyzer from BloCHEM IMMUNOSYSTEMS (U. S.), INC. of Allentown Pennsylvania is a fully automated microplate analyzer. The analyzer is used for the in vitro diagnostic processing of human and animal specimens with Immunoenzymatic techniques, developed on 96 well microplate formats, such as: E.I.A. (Enzyme Immuno Assay), and E.L.I.S.A. (Enzyme Linked Immuno Sorbent Assay). The PersonalLAB™ Automated Microplate Analyzer is intended to duplicate the manual analytical procedures associated to an assay and the assay's reagents, by performing automatically the various steps identified in the assay manufacturer's Instructions For Use. The steps performed are as follows: Specimen handling and identification, Specimen pipetting and pre-dilution, Reagent distribution and pipetting. Washing of the microplates. Incubation of the microplates, Photometric reading of the microplates, Data analysis -- both quantitative and qualitative, Data management - displaying, printing and archiving, and Waste management. The PersonalLAB™ Automated Microplate Analyzer is used for the in vitro diagnostic processing of various specimen types, as define by the assay manufacturer's instructions for use. Examples of specimen types are as follows: Whole blood, Serum. Plasma. Urine, Stool. Spinal fluid, Saliva, and Swabs from antigen sites.

This document is a 510(k) premarket notification for the PersonalLAB™ Automated Microplate Analyzer. It describes the indications for use of the device but does not contain information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide details about sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval letter from the FDA, not a performance study report.

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