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SAS Salmonella O Group Y Factor 48 Antiserum

FDA 510(k)

Class II (US FDA 510(k))

510(k) K960129

by Sa Scientific, Inc.

Identifiers

510(k) Number
K960129 FDA 510(k)
FDA Product Code
GRM 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 Salmonella Antiserum, All Groups (GRM classification), designed for serological identification of Salmonella bacteria. It contains antibodies specific to Salmonella O Group Y and Factor 48, aiding in the differentiation of bacterial strains for diagnostic purposes in microbiology.

The antiserum is supplied as a liquid reagent for laboratory use, intended for single-use in agglutination tests. It is classified as a Class II medical device under FDA regulations and requires sterile conditions for handling. Storage and handling instructions are detailed in the accompanying documentation, and its regulatory status is confirmed by FDA 510(k) clearance (K960129).

Frequently asked questions

What is the primary use of the Salmonella O Group Y Factor 48 Antiserum in a clinical or laboratory setting?

This antiserum is specifically designed for serological identification of *Salmonella* bacteria in microbiology labs. It contains antibodies that help differentiate bacterial strains by detecting the presence of *Salmonella* O Group Y and Factor 48 antigens, aiding in accurate bacterial strain classification for diagnostic purposes.

How is the Salmonella O Group Y Factor 48 Antiserum supplied, and is it intended for single-use?

The antiserum is supplied as a liquid reagent, intended exclusively for single-use in agglutination tests. Since it is a sterile product, it should not be reused to maintain accuracy and prevent contamination.

What storage and handling precautions should be taken with this antiserum?

While specific storage instructions are detailed in the accompanying documentation, the antiserum requires sterile handling due to its classification as a sterile medical device. Proper storage conditions (e.g., refrigeration, protection from light) are critical to preserve its efficacy and prevent degradation.

How was the regulatory pathway for this device determined, and what does that mean for its use?

This device follows a Traditional 510(k) pathway with a Substantially Equivalent (SESE) determination by the FDA’s Microbiology Advisory Committee (MI). This means it was reviewed for safety and effectiveness against a legally marketed predicate device, confirming its compliance with FDA standards for serological reagents in microbiology.

Is this antiserum compatible with all agglutination testing methods, or are there specific protocols to follow?

The antiserum is designed for use in agglutination tests as specified in its description, but exact protocols (e.g., dilution ratios, incubation times) should be followed as outlined in the manufacturer’s instructions. Compatibility depends on adherence to the provided laboratory guidelines to ensure accurate results.

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 O GROUP Y FACTOR 48 ANTISERUM (K960129) — FDA 510 (k ..., PDF K960129 - Sas Salmonella O Group Y Factor 48 Antiserum, SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM 510 (k)… - FDA.report, Antisera, All Groups, Salmonella Spp. GRM - FDA.report, Sas Salmonella O Factor 4 Antiserum &/Or Sas Salmonella O Group B ...

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) K960129 24 fields · synced Sep 19, 2026