LogoFDA 510(k) Search
K Number
K972391
Device Name
VISTA ANTIGEN SALMONELLA H B
Manufacturer
LEE LABORATORIES, INC.
Date Cleared
1997-08-25

(60 days)

Product Code
GNC
Regulation Number
866.3550
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

Device Description

Not Found

AI/ML Overview

This document (K972391) is a 510(k) clearance letter from the FDA for the VISTA™ Antigen Salmonella H b device. It states that the device is substantially equivalent to legally marketed predicate devices. However, the provided text does not contain the detailed study information, acceptance criteria, or performance data that would be required to answer your specific questions about the device's technical performance.

The letter focuses on the regulatory clearance of the device based on substantial equivalence, rather than a detailed technical report of its performance or the clinical study that led to its validation.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the regulatory clearance letter. The letter acknowledges the device's substantial equivalence but does not detail performance metrics or acceptance criteria.
  2. Sample sizes used for the test set and the data provenance: This information is not provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
  4. Adjudication method for the test set: This information is not provided.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not provided.
  6. If a standalone performance study was done: The document doesn't detail the studies performed, but rather the regulatory outcome based on submitted data.
  7. The type of ground truth used: This information is not provided.
  8. The sample size for the training set: This information is not provided.
  9. How the ground truth for the training set was established: This information is not provided.

The current document is a regulatory approval letter, not a clinical study report. To obtain the information you're asking for, you would typically need to refer to the 510(k) submission summary or the actual studies cited within the submission, which are not part of this letter.

§ 866.3550

Salmonella spp. serological reagents.(a)
Identification. Salmonella spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identifySalmonella spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifySalmonella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of salmonellosis caused by bacteria belonging to the genusSalmonella and provides epidemiological information on this disease. Salmonellosis is characterized by high grade fever (“enteric fever”), severe diarrhea, and cramps.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.