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K Number
K993812
Device Name
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
Manufacturer
HARDY DIAGNOSTICS
Date Cleared
1999-12-21

(41 days)

Product Code
JSM
Regulation Number
866.2390
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

§ 866.2390 Transport culture medium.

(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).