(35 days)
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No
The device description focuses on the physical components and mechanism for collecting and transporting microbiological specimens, with no mention of AI or ML capabilities.
No
This device is intended for the collection, preservation, and transportation of microbiological specimens, not for therapeutic purposes.
No
This device is intended for the collection, preservation, and transportation of microbiological specimens to the laboratory for analysis, which is a precursor to diagnosis, not a diagnostic act itself.
No
The device description clearly outlines physical components (plastic parts, swabs, brush, media) and a physical mechanism for media release, indicating it is a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "collection, preservation, and transportation of microbiological specimens." These specimens are then transported to a laboratory for "microbiological analysis." This analysis is performed in vitro (outside of the living body) to diagnose or detect conditions.
- Device Description: The device is designed to collect and preserve biological samples (microbiological specimens) for subsequent testing. The transport media is crucial for maintaining the viability of the microorganisms during transport to the lab for analysis.
- Context of Use: The device is used to collect samples from anatomical sites (male urethral or nasopharyngeal specimens) that are then analyzed in a laboratory setting. This is a typical workflow for IVD devices used in microbiology.
While the device itself doesn't perform the diagnostic test, it is an essential component of the overall in vitro diagnostic process by providing the means to collect and transport the sample for analysis.
N/A
Intended Use / Indications for Use
Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Modified Amies Transport Media, is intended for use as a disposable, sterile culture collection device for use in the collection, preservation, and transportation of microbiological specimens.
Product codes
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Device Description
Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System. Modified Amies Transport Media, is substantially equivalent to Medical Packaging Corporation's Culture Collection and Transport Device (K881105), and CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K936078) and ( K932337/S1). Listed devices are intended to collect, preserve, and transport clinical specimens to the laboratory for microbiological analysis. Devices are composed of two plastic parts:
- . The top plastic part holds 0.4 mL of clinical transport media and a plastic shaft, Rayon® tipped swab. Configuration of the CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, will also provide two plastic shaft, Rayon® tipped swabs; an aluminum shaft, Rayon® Mini-Tip swab for collection of either male urethral or nasopharyngeal specimens; or a CytoSoft™ cytology brush.
- The bottom plastic part protects the swab(s) or brush ( hereafter referred to . as: collection device ) and fits tightly into the top plastic part. The CULTURE-PAK™ and the Culture Collection and Transport Device are packaged sterile. Sterilization is conducted at SteriGenics, International, Inc., and validated by North American Science Associates, Inc. for both devices.
The methods for use are similar for the CULTURE-PAK™ and the Culture Collection and Transport Device. The two plastic parts are pulled apart, exposing the swab(s) or brush. After the culture is collected, the bottom is refitted into the top. The media seal is broken and the fluid is forced into the bottom extrusion to keep the collection device moist for up to 48 hours at room temperature.
The primary differences between Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System and the Culture Collection and Transport Device are how the media is contained, how to free the media so it will flow down into the bottom plastic part, and the provision of additional specimen collection devices as configured. The CULTURE-PAK™ has a plastic plug that holds the media in the top part. The top is bent 45 ° to break the plug allowing the media to flow into the bottom. The Culture Collection and Transport Device has a glass ampule that holds the media in the top plastic part. The top is squeezed to crush the ampule allowing the media to flow into the bottom. The CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media will also be available with an aluminum shaft Rayon® Mini-Tip rayon swab and a CytoSoft™ cytology brush.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safe Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.
DATE OF SUMMARY PREPARATION: 17 November, 1996
| COMPANY: | Medical Packaging Corporation
941 Avenida Acaso
Camarillo, CA 93012-8700
Phone: 805-388-2383
Fax: 805-388-5531 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Patricia V. Willis |
| DEVICE NAME: | CULTURE-PAK™
Collection and Transport System,
Modified Amies Transport Media |
| DEVICE CLASSIFICATION: | Class I, General Controls |
| COMMON NAME: | Microbiological specimen collection and
transport device |
| PREDICATE DEVICE(S): | Culture Collection and Transport
Device (K881105), CULTURE-PAK™
Collection and Transport System, Modified
Stuart's Media (K932337/S1 and K936078
Medical Packaging Corporation
Camarillo, CA |
Intended Use
Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System, with Modified Amies Transport Media, is intended for use as a disposable, sterile culture collection device for use in the collection, preservation, and transportation of microbiological specimens.
1
510(k) Notification . 17 November, 1996 Medical Packaging Corporation CULTURE-PAK™ Collection and Transport System with Modified Amies Media
Substantial Equivalence
Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System. Modified Amies Transport Media, is substantially equivalent to Medical Packaging Corporation's Culture Collection and Transport Device (K881105), and CULTURE-PAK™ Collection and Transport System, Modified Stuart's Media (K936078) and ( K932337/S1). Listed devices are intended to collect, preserve, and transport clinical specimens to the laboratory for microbiological analysis. Devices are composed of two plastic parts:
- . The top plastic part holds 0.4 mL of clinical transport media and a plastic shaft, Rayon® tipped swab. Configuration of the CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media, will also provide two plastic shaft, Rayon® tipped swabs; an aluminum shaft, Rayon® Mini-Tip swab for collection of either male urethral or nasopharyngeal specimens; or a CytoSoft™ cytology brush.
- The bottom plastic part protects the swab(s) or brush ( hereafter referred to . as: collection device ) and fits tightly into the top plastic part. The CULTURE-PAK™ and the Culture Collection and Transport Device are packaged sterile. Sterilization is conducted at SteriGenics, International, Inc., and validated by North American Science Associates, Inc. for both devices.
The methods for use are similar for the CULTURE-PAK™ and the Culture Collection and Transport Device. The two plastic parts are pulled apart, exposing the swab(s) or brush. After the culture is collected, the bottom is refitted into the top. The media seal is broken and the fluid is forced into the bottom extrusion to keep the collection device moist for up to 48 hours at room temperature.
The primary differences between Medical Packaging Corporation's CULTURE-PAK™ Collection and Transport System and the Culture Collection and Transport Device are how the media is contained, how to free the media so it will flow down into the bottom plastic part, and the provision of additional specimen collection devices as configured. The CULTURE-PAK™ has a plastic plug that holds the media in the top part. The top is bent 45 ° to break the plug allowing the media to flow into the bottom. The Culture Collection and Transport Device has a glass ampule that holds the media in the top plastic part. The top is squeezed to crush the ampule allowing the media to flow into the bottom. The CULTURE-PAK™ Collection and Transport System, Modified Amies Transport Media will also be available with an aluminum shaft Rayon® Mini-Tip rayon swab and a CytoSoft™ cytology brush.
2
510(k) Notification · 17 November, 1996 Medical Packaging Corporation CULTURE-PAK™ Collection and Transport System with Modified Amies Media
All used materials should be treated as potentially infectious and biohazardous. Proper handling and disposal methods should be employed.
Patricia Willis Date: 11.18.96
Paricia V. Willis Director, Product Management and Regulatory Affairs