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The IMMULITE® 2000 Allergen-Specific IgE and specific allergens are for in vitro diagnostic use with the IMMULITE® 2000 Analyzer - for the measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

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The provided text is a 510(k) clearance letter from the FDA for the IMMULITE® 2000 Specific Allergens device. It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, the letter does not contain the detailed information required to answer your questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) submission itself, which is a much more extensive document than the clearance letter.

Therefore, based only on the provided text, I cannot complete the table or answer most of your specific questions.

Here's what I can infer from the document:

• Device Name: IMMULITE® 2000 Specific Allergens
• Intended Use: For in vitro diagnostic use with the IMMULITE® 2000 Analyzer for the measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE-mediated allergic disorders.
• Regulatory Class: Class II
• Regulatory Number: 21 CFR § 866.5750 (Radioallergosorbent (RAST) Immunological Test System)
• Product Code: DHB
• Type of Study (Implied): A study demonstrating substantial equivalence to a predicate device was conducted, but details are not provided. This would have involved comparing performance metrics.

To answer your questions comprehensively, you would need access to the full 510(k) submission document (K021206).

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