LogoFDA 510(k) Search
K Number
K961756
Device Name
CYTOQUANT VIRAL TRANSPORT MEDIUM
Manufacturer
PROTEINS INTL., INC.
Date Cleared
1996-05-17

(11 days)

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

microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms.

Device Description

microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory.

AI/ML Overview

This document does not contain the information required to complete the request. The provided text is a "Safety & Effectiveness Summary" for a Viral Transport Medium, which focuses on regulatory classification, safety precautions for handling the product, and general statements about its effectiveness based on published literature and internal quality control.

Here's why the specific questions cannot be answered from the provided text:

  • Acceptance Criteria and Reported Device Performance (Table): The document states "Proteins International conducts its own studies on each lot of Viral Transport Medium manufactured, using the following criteria: appearance, sterility, toxicity, and ability of the medium to maintain virus viability over time." However, it does not provide specific numerical acceptance criteria for these attributes (e.g., "maintain virus viability for X hours at Y temperature with Z% recovery") nor does it report the specific performance results against these criteria for any particular study. It only states that "Complete study results for each lot are available on request."
  • Sample Size (Test Set), Data Provenance: No details about a specific test set, its sample size, or data provenance (e.g., country, retrospective/prospective) are mentioned.
  • Number of Experts, Qualifications: Not applicable as no expert-based ground truth establishment is described.
  • Adjudication Method: Not applicable.
  • MRMC Comparative Effectiveness Study: No mention of a multi-reader, multi-case study comparing human readers with and without AI assistance.
  • Standalone Performance: No standalone algorithm performance is described as this is a physical medical device (viral transport medium), not an AI algorithm.
  • Type of Ground Truth: The "effectiveness" mentioned refers to maintaining virus viability, which implies laboratory assays rather than expert consensus, pathology, or outcomes data in the context of an AI device.
  • Sample Size (Training Set): No training set information is applicable or provided, as this is not an AI/machine learning device.
  • Ground Truth (Training Set): Not applicable for the same reason.

In summary, the document describes a viral transport medium and its general safety and effectiveness, but it does not detail a specific study with acceptance criteria and results in a format applicable to evaluating a diagnostic device or AI algorithm's performance. It refers to internal quality control studies for each manufacturing lot, but doesn't provide the specifics of those studies.

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MAY 17 1996

SAFETY & EFFECTIVENESS SUMMARY CytoQuant™ VIRAL TRANSPORT MEDIUM

A. SAFETY

According to 21 CFR 866.2900, microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms. These devices are classified as (lass I (general controls).

Proteins International recommends that the Cyto()uant™ Viral Transport Medium be handled at BioSafety Level II with the following precautions taken:

  • 1 . Access to the laboratory is limited .
    1. All work surfaces are Decontaminated before and after each procedure.
    1. Use of automatic pipetting devices is mandatory for all procedures - mouth pipetting is prohibited.
    1. Eating, drinking, smoking, and applying cosmetics is not permitted in the laboratory, nor is food stored in the lab areas.
  • ട. Laboratory coats are worn in the laboratory and removed before leaving.
    1. Hand washing is required before and after handling transport medium.
    1. A class II laminar flow biological safety cabinet is used for all manipulations which may create aerosols whether or not the procedure requires sterility.
    1. Contaminated materials are placed in leakproof, autoclavable discard pans filled with distilled water.
    • These pans are closed before removal from the cabinet.
    1. Larger plasticware, such as a tissue culture flask, which does not fit in a discard pan, is to be closed and placed in an autoclave bag.
    1. All contaminated materials are aut oclaved before disposal.
    1. Contaminated liquid media collected by vacuum aspiration is inactivated by the addition of bleach to make a 1:15 bleach to media solution, and then discarded.
    1. Disposable latex gloves are worn when skin contact with infectious materials is unavoidable or at the discretion of the operator.

Proteins International also has available on request a copy of the MSDS for any antibiotic or antimycotic agent used in the formulation of the medium.

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B. EFFECTIVENESS

The CytoQuant™ Viral Transport Medium (Tryptose Phosphate Broth) is widely recognized as an effective medium for transport of viruses. 1, 2, 3

Additionally, Proteins International conducts its own studies on each lot of Viral Transport Medium manufactured, using the following criteria: appearance, sterility, toxicity, and ability of the medium to maintain virus viability over time. Complete study results for each lot are available on request, as well as suggested OC/OA procedures for those users wishing to perform their own quality testing.

References:

  1. Johnson, F. B. 1990. Transport of Viral Specimens. Clin. Micobiol. Rev. 3: 120-131

  2. Lennette, D. A. 1985. Collection and preparation of specimens for virological examination, p 687-693. In E. H. Lennette, A. Balows, W. J. Housler, Jr. and H. J. Shadomy (Eds), Manual of clinical microbiology, 4th ed. American Society for Microbiology, Washington, D. C.

  3. Madeley, C. F., D. A. Lennette and P Halonen. 1988. Specimen collection and transport, p.7-11. IN E. H. Lennettee, P. Halonen and F. A. Murphy (Eds), Laboratory diagnosis of infectious diseases, principles and practice, vol 2. Springer Verlag, New York.

§ 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).