FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral, chlamydial, and mycoplasmal agents including: Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Influenzae A. Influenzae B, Respiratory Synctial Virus (RSV), Echovirus, Adenovirous, Chlamydia trachomatis, C. pneumoniae, Mycoplasma hominis, M. pneumoniae and Ureaplasma urealvticum.

Viral Transport Media: CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents including: Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Respiratory Synctial Virus (RSV), Echovirus, and Adenovirous.

Device Description

CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral, chlamydial, and mycoplasmal agents.

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA to Hardy Diagnostics for their CVM Transport Media. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device and does not contain the detailed study information you've requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot extract the information required to populate the table and answer your questions directly from this document.

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K Number

K955451

Device Name

CVM TRANSPORT

Manufacturer

HARDY DIAGNOSTICS

Date Cleared

1996-07-22

(236 days)