← Product Code [JSN](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSN) · K961756

# CYTOQUANT VIRAL TRANSPORT MEDIUM (K961756)

_Proteins Intl., Inc. · JSN · May 17, 1996 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSN/K961756

## Device Facts

- **Applicant:** Proteins Intl., Inc.
- **Product Code:** [JSN](/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSN.md)
- **Decision Date:** May 17, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.2390
- **Device Class:** Class 1
- **Review Panel:** Microbiology

## Indications for 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 Story

CytoQuant Viral Transport Medium (Tryptose Phosphate Broth) serves as a collection and transport vessel for clinical specimens; preserves viability/integrity of microorganisms during storage and transit from collection site to laboratory. Used by clinical laboratory personnel; requires BioSafety Level II handling precautions; includes mandatory use of automatic pipetting, laminar flow biological safety cabinets, and decontamination protocols. Medium formulation includes antibiotic/antimycotic agents. Device aids in diagnosis of diseases caused by pathogenic microorganisms by ensuring sample stability for subsequent laboratory analysis.

## Clinical Evidence

Bench testing only. Manufacturer performs lot-specific quality control testing for appearance, sterility, toxicity, and viral viability maintenance over time.

## Technological Characteristics

Tryptose Phosphate Broth-based medium; contains antibiotic/antimycotic agents. Class I microbiological specimen collection and transport device.

## Regulatory 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.

## Reference Devices

- Johnson, F. B. 1990. Transport of Viral Specimens. Clin. Micobiol. Rev. 3: 120-131
- Lennette, D. A. 1985. Collection and preparation of specimens for virological examination
- Madeley, C. F., D. A. Lennette and P Halonen. 1988. Specimen collection and transport

## Submission Summary (Full Text)

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K961756

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 Class I (general controls).

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

1. Access to the laboratory is limited.
2. All work surfaces are Decontaminated before and after each procedure.
3. Use of automatic pipetting devices is mandatory for all procedures - mouth pipetting is prohibited.
4. Eating, drinking, smoking, and applying cosmetics is not permitted in the laboratory, nor is food stored in the lab areas.
5. Laboratory coats are worn in the laboratory and removed before leaving.
6. Hand washing is required before and after handling transport medium.
7. A class II laminar flow biological safety cabinet is used for all manipulations which may create aerosols whether or not the procedure requires sterility.
8. Contaminated materials are placed in leakproof, autoclavable discard pans filled with distilled water. These pans are closed before removal from the cabinet.
9. 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.
10. All contaminated materials are autoclaved before disposal.
11. 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.
12. 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 QC/QA 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.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSN/K961756](https://fda.innolitics.com/submissions/MI/subpart-c%E2%80%94microbiology-devices/JSN/K961756)

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