CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM

K961755 · Proteins Intl., Inc. · JSN · May 17, 1996 · Microbiology

Device Facts

• Record ID: K961755
• Device Name: CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM
• Applicant: Proteins Intl., Inc.
• Product Code: JSN · Microbiology
• Decision Date: May 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2390
• Device Class: Class 1

Indications for Use

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.

Device Story

CytoQuant™ Chlamydia Transport Medium (2SP) serves as a specimen collection and transport device; preserves viability/integrity of Chlamydia microorganisms during storage and transport from collection site to laboratory. Used by clinical laboratory personnel; requires BioSafety Level II handling precautions. Device aids in diagnosis of disease caused by pathogenic microorganisms. Effectiveness supported by established literature and lot-specific quality control testing (appearance, sterility, toxicity, viability maintenance).

Clinical Evidence

Bench testing only. Manufacturer conducts lot-specific quality control testing for appearance, sterility, toxicity, and viability maintenance of Chlamydia over time. Effectiveness is supported by recognized clinical microbiology literature.

Technological Characteristics

Microbiological specimen collection and transport medium (2SP formulation). Contains antibiotic/antimycotic agents. Requires BioSafety Level II handling, including use of laminar flow biological safety cabinets and autoclaving of contaminated materials.

Indications for Use

Indicated for the collection and transport of clinical specimens to preserve the viability of Chlamydia microorganisms for laboratory diagnosis.

Regulatory Classification

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
• Schachter, J. 1986. Chlamydia, p.494. In: S Specter and G. J. Lancz. Clinical Virology Manual. Elsevier, New York.
• Vera, H. D. and D. A. Power. 1980. Culture media, p 978. In E. H. Lennette, A. Balows, W. J. Housler, Jr. and J. P. Truant (Eds). Manual of Clinical Microbiology, 3d Ed. American Society for Microbiology, Washington, D. C.

Submission Summary (Full Text)

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K961755

# SAFETY & EFFECTIVENESS SUMMARY CYTOQUANT™ CHLAMYDIA TRANSPORT MEDIUM

MAY 17 1996

## 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™ Chlamydia 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.

## B. EFFECTIVENESS

The CytoQuant™ Chlamydia Transport Medium (2SP) is widely recognized as an effective medium for chlamydia transport (1, 2, 3)

Additionally, Proteins International conducts its own studies on each lot of Chlamydia Transport Medium manufactured, using the following criteria: appearance, sterility, toxicity, and ability of the medium to maintain chlamydia viability over time. Complete

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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. Schachter, J. 1986. Chlamydia, p.494. In: S Specter and G. J. Lancz. Clinical Virology Manual. Elsevier, New York.
3. Vera, H. D. and D. A. Power. 1980. Culture media, p 978. In E. H. Lennette, A. Balows, W. J. Housler, Jr. and J. P. Truant (Eds). Manual of Clinical Microbiology, 3d Ed. American Society for Microbiology, Washington, D. C.