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SAS Salmonella H L, Z40 Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K955202

by Sa Scientific, Inc.

Identifiers

510(k) Number
K955202 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 a Slide and Tube Antigen, Febrile, Salmonella spp. per FDA nomenclature (GNC product code), designed for serological testing to identify Salmonella bacteria. It functions as an antisera reagent, enabling agglutination reactions to detect specific somatic (O) and flagellar (H) antigens associated with Salmonella strains, aiding in microbiological identification and epidemiological studies.

The SAS Salmonella H L, Z40 Antiserum is supplied as a liquid reagent for laboratory use in slide or tube agglutination tests. It is intended for single-use and requires no sterilisation beyond standard aseptic handling procedures. The device is classified as Class II under FDA regulations (866.3550) and has received FDA 510(k) clearance (K955202) for substantial equivalence. Storage conditions are not specified but should follow standard laboratory protocols for antisera.

Frequently asked questions

What is the SAS Salmonella H L, Z40 Antiserum used for in a clinical or research setting?

The SAS Salmonella H L, Z40 Antiserum is designed for serological testing to detect *Salmonella* bacteria by identifying specific somatic (O) and flagellar (H) antigens. It works through agglutination reactions in slide or tube tests, helping microbiologists identify *Salmonella* strains and support epidemiological studies. It is not intended for direct patient treatment but for laboratory diagnostics.

How is the SAS Salmonella H L, Z40 Antiserum supplied, and what are its handling requirements?

This device is supplied as a liquid reagent for laboratory use in slide or tube agglutination tests. It is intended for single-use only and does not require additional sterilization beyond standard aseptic handling. Since it is a biological reagent, it should be stored according to general laboratory protocols for antisera to maintain integrity, though specific storage conditions (e.g., temperature) are not detailed in the data.

Is this product reusable, and if not, why is it designed for single-use?

The SAS Salmonella H L, Z40 Antiserum is explicitly labeled for single-use because it is a biological reagent used in diagnostic testing. Repeated use could compromise its effectiveness, introduce contamination risks, or alter the agglutination reaction accuracy. Single-use ensures reliable test results and reduces cross-contamination in microbiological workflows.

What regulatory pathway was followed for FDA clearance, and what does that mean for buyers?

The device underwent a traditional 510(k) review through the FDA’s Microbiology advisory committee (MI), with a decision of *substantial equivalence* (SESE) under product code GNC (Slide and Tube Antigens, Febrile, *Salmonella* spp.). This means Sa Scientific demonstrated the device is substantially equivalent to a legally marketed predicate device, confirming its safety and performance for the intended use in serological testing. Buyers can rely on this clearance for compliance with U.S. regulatory requirements.

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 H L,Z40 ANTISERUM (K955202) - FDA 510 (k), PDF K955202 - Sas Salmonella H L,Z40 Antiserum, PDF SalmonellaAntisera - Bio-Rad, SAS SALMONELLA H Z4, Z23 ANTISERUM - Innolitics

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) K955202 24 fields · synced Sep 19, 2026