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Salmonella E, N, X Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K955214

by Sa Scientific, Inc.

Identifiers

510(k) Number
K955214 FDA 510(k)
FDA Product Code
GNC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3550 FDA 510(k)
Regulation Number
866.3550 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an Antigens, Febrile, Slide and Tube for Salmonella species, classified under FDA regulation 866.3550. It is designed as a diagnostic aid to identify Salmonella bacteria (serotypes E, N, and X) in clinical specimens, supporting the identification of salmonellosis and epidemiological tracking of the pathogen. The antiserum facilitates serological testing to differentiate bacterial strains based on their antigenic properties.

The Salmonella E, N, X Antiserum is supplied as a single-use diagnostic reagent for microbiological laboratories, intended for use in slide agglutination and tube agglutination tests. It is sterile and requires proper storage as specified by the manufacturer to maintain efficacy. Authorized under FDA 510(k) clearance (K955214) with a Class II designation, this device adheres to microbiology-specific regulatory standards. No MRI safety or reusable components are indicated in the specifications.

Frequently asked questions

What types of tests can this antiserum be used for in a clinical setting?

This Salmonella E, N, X Antiserum is specifically designed for use in slide agglutination and tube agglutination tests. These methods help microbiology labs identify *Salmonella* bacteria (serotypes E, N, and X) in clinical specimens by detecting antigenic reactions, which aids in diagnosing salmonellosis and tracking outbreaks.

Is this product single-use or reusable, and how should it be stored?

The Salmonella E, N, X Antiserum is intended for single-use only as a diagnostic reagent. To maintain its efficacy, it must be stored according to the manufacturer’s instructions, as sterility and stability are critical for accurate serological testing. Improper storage could compromise results.

What regulatory pathway was followed for FDA clearance, and what class designation does this device hold?

This device received FDA 510(k) clearance (K955214) under the Traditional 510(k) review pathway, with a Class II designation. The submission was reviewed by the Microbiology (MI) Advisory Committee, and the device was determined to be substantially equivalent to a predicate product, ensuring compliance with microbiology-specific regulatory standards.

Does this antiserum require any special handling beyond standard microbiology lab procedures?

Beyond standard microbiology lab practices, this antiserum is sterile and must be handled with care to prevent contamination. Since it is a single-use reagent, it should be stored securely (as per manufacturer guidelines) and not reused, as reuse could introduce errors or cross-contamination in serological testing.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SAS SALMONELLA E,N,X ANTISERUM (K955214) - FDA 510 (k), SAS SALMONELLA E,N,X ANTISERUM by SA SCIENTIFIC, INC. | FDA 510 (k) Summary, Sas Salmonella E,n,x Antiserum 510 (k) FDA Premarket Notification ..., PDF K955214 SAS SALMONELLA E,N,X ANTISERUM - 510kdatabase.net, Sas Salmonella 0 Group E Factors 1,3,10,15,19,34 Antiserum

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sa Scientific, Inc.

Sources (1)

  • FDA 510(k) K955214 24 fields · synced Sep 19, 2026