Captia Hsv 1 Igg Type Specific Elisa Kit

510(k) Number

K033105 ↗

FDA Product Code

MXJ

Device Class

Class II

Regulation

21 CFR Part 866.3305

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the primary clinical purpose of the Captia HSV-1 IgG Type Specific ELISA Kit, and how does it differ from testing for HSV-2?

  The Captia HSV-1 IgG Type Specific ELISA Kit is designed to qualitatively detect IgG antibodies specific to Herpes Simplex Virus Type 1 (HSV-1) in human serum. Unlike general HSV testing, this kit helps differentiate HSV-1 antibodies from those of HSV-2, enabling laboratories to confirm HSV-1 infections specifically. This distinction is critical for accurate diagnosis and patient management, as HSV-1 and HSV-2 infections have different clinical implications and treatment considerations.

• Is this kit intended for single-use, or can it be reused across multiple tests?

  The Captia HSV-1 IgG Type Specific ELISA Kit is explicitly labeled as a single-use diagnostic reagent. This means each kit is designed for one assay cycle and should not be reused, as reuse could compromise accuracy, sterility, or performance. The manufacturer’s instructions align with standard in vitro diagnostic protocols, which emphasize single-use for diagnostic assays to ensure reliable results.

• What type of sample does this ELISA kit require, and are there any special handling or storage requirements?

  The kit requires human serum samples for testing. Storage and handling follow standard protocols for in vitro diagnostic assays, though specific details like temperature ranges or expiration are not provided in the data. Generally, ELISA kits like this are stored at 2–8°C (36–46°F) until use, protected from light and moisture. Always refer to the included instructions for the manufacturer’s precise storage guidelines to maintain assay integrity.

• How is this device classified under FDA regulations, and what does that mean for its use in clinical settings?

  The Captia HSV-1 IgG Type Specific ELISA Kit is classified as a Class II medical device under FDA regulations (21 CFR 866.3305). This classification indicates it poses moderate risk and requires premarket notification (510(k)) clearance to demonstrate substantial equivalence to a predicate device. Clinically, this means it has undergone FDA review for safety and effectiveness, ensuring it meets performance standards for diagnosing HSV-1 infections in laboratory settings. The clearance (K033105) confirms its compliance with regulatory requirements.

• Are there different sizes or models of this kit, or is it supplied as a single standardized version?

  The provided data does not specify multiple sizes or models for the Captia HSV-1 IgG Type Specific ELISA Kit. It is described as a single standardized kit for qualitative detection of HSV-1 IgG antibodies. If variations exist (e.g., different reagent volumes or test strip quantities), they are not detailed in the available information. Always verify the exact contents of the kit with the manufacturer’s documentation or packaging.