(11 days)
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No K/DEN numbers were found in the text.
No
The summary describes a microbiological specimen collection and transport medium, which is a chemical substance for preserving samples, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, image processing, or data analysis capabilities.
No
The device is a specimen collection and transport medium for microbiological samples, used to preserve microorganisms for diagnosis, not to treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section states: "The device aids in the diagnosis of disease caused by pathogenic microorganisms."
No
The device description clearly states it is a "Chlamydia Transport Medium," which is a physical substance used for specimen collection and transport, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is a "specimen collecting chamber 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." It also states that the device "aids in the diagnosis of disease caused by pathogenic microorganisms." This aligns directly with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description identifies it as a "Chlamydia Transport Medium," which is a substance used to transport biological specimens for laboratory analysis.
- Care Setting: The intended user is a "laboratory," which is where in vitro diagnostic testing is performed.
The information provided clearly indicates that this device is used to collect and transport specimens for laboratory testing to aid in the diagnosis of disease, which is the core function of an IVD.
N/A
Intended Use / 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.
Product codes
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Device Description
The CytoOuant™ Chlamydia Transport Medium is a microbiological specimen collection and transport device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Laboratory personnel (BioSafety Level II)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 study results for each lot are available on request.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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SAFETY & EFFECTIVENESS SUMMARY CYTOQUANT™ CHLAMYDIA 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 CytoOuant™ Chlamydia Transport Medium be handled at BioSafety Level II with the following precautions taken:
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- Access to the laboratory is limited .
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- All work surfaces are Decontaminated before and after each procedure.
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- Use of automatic pipetting devices is mandatory for all procedures mouth pipetting is prohibited.
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- Eating, drinking, smoking, and applying cosmetics is not permitted in the laboratory, nor is food stored in the lab areas.
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- Laboratory coats are worn in the laboratory and removed before leaving.
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- Hand washing is required before and after handling transport medium.
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- A class II laminar flow biological safety cabinet is used for all manipulations which may create aerosols whether or not the procedure requires sterility.
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- 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.
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- All contaminated materials are autoclaved before disposal.
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- 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.
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- Disposable latex gloves are worn when skin contact with infectious materials is unavoidable or at the ciscretion 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:
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Johnson, F. B. 1990. Transport of Viral Specimens. Clin. Micobiol. Rev. 3:120-131
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Schachter, J. 1986. Chlamydia, p.494. In: S Specter and G. J. Lancz. Clinical Virology Manual. Elsevier, New York.
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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.