(264 days)
Not Found
No
The device description and performance studies focus on the chemical composition and preservation capabilities of a fecal specimen collection medium, with no mention of AI or ML technologies.
No
The device is described as a collection and preservation medium for fecal specimens for the culture of intestinal enteric bacteria, which is a diagnostic purpose, not a therapeutic one.
No
The device is a medium for collecting and preserving fecal specimens for the culture of intestinal enteric bacteria. It does not perform any diagnostic function itself.
No
The device description clearly outlines a physical product consisting of a solution, vial, spoon, and optional instruction sheet and bag. It is a collection and preservation medium, not a software application.
Based on the provided information, the Para-FixTM Cary Blair Medium is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for "collecting and preserving fecal specimens for the culture of intestinal enteric bacteria." This process of collecting and preserving biological specimens for subsequent laboratory analysis (culture in this case) is a core function of IVD devices.
- Device Description: The description details a medium designed to maintain the viability of bacteria in a specimen, which is crucial for accurate diagnostic testing (culturing).
- Performance Studies: The performance studies describe testing the device's ability to maintain enteric organisms using laboratory techniques like plate counts and culturing on appropriate media. This demonstrates that the device is intended to be used in a laboratory setting for diagnostic purposes.
- Predicate Device: The predicate device listed, "Meridian Para-Pak C&S," is also a specimen collection and transport system for culture and sensitivity testing, which are common IVD applications.
Therefore, the Para-FixTM Cary Blair Medium fits the definition of an In Vitro Diagnostic device as it is intended for use in the collection and preservation of biological specimens for subsequent in vitro diagnostic procedures (bacterial culture).
N/A
Intended Use / Indications for Use
Para-FixTM Cary Blair Medium provides a method for collecting and preserving fecal specimens for the culture of intestinal enteric bacteria. Because the medium is capable of maintaining the bacteria for 96 hours, immediate transportation and processing of the specimen is not necessary.
Product codes (comma separated list FDA assigned to the subject device)
JSM, LIO
Device Description
Para-Fix Cary Blair Medium is a non-nutritive, buffered, isotonic solution with a pH indicator added. The medium also contains agar and sodium thioglycolate to maintain a low oxygen tension for the preservation of anaerobic species. The phenol red indicator will turn yellow when the solution is acidic and the conditions are not optimal for recovery of the intended organisms. Each 30 mL vial contains 15 ml of solution and a built in sample collection spoon. The kit is available with or without a multilingual instruction sheet and re-sealable bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
First Cary Blair vials were seeded with suspensions of enteric organisms in the absence of fecal matrix. Vials were held at 2-8°C and sampled at 0 and 96 hours by Swab Elution plate counts. Orqanisms were cultured on appropriate media to assure accurate recovery of seeded organisms. The performance criterion as specified by Clinical and Laboratory Standards Institute (CLSI), M40-A2 was met for the 10 enteric organisms previously listed.
Second, Para-Fix Cary Blair Medium was tested for its ability to maintain pathogenic enteric organisms spiked into clinically negative human fecal matrix. Clinically negative human fecal matrix was added to Cary Blair vials that were then seeded with suspensions of enteric organisms. Vials were held at 2-8°C and 20-25°C and sampled at 0, 72, 96 and 120 hours by serial dilution plate counts, and by the Roll-Plate method using sterile swabs (Fisher 23-400-122). Organisms were cultured on selective media to assure accurate recovery of seeded organisms. The performance criterion as specified by CLSI M40-A2 was met for Swab Elution or the Roll-Plate method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bacteriostasis study demonstrates that Para-Fix Cary Blair Medium preserves representative bacterial species for 96 hours at 2-8°C and 20-25°C. These species include potential pathogens that may be found in fecal samples: Campylobacter jejuni. Clostridium difficile, Enterococcus faecalis, Bacillus subtilis, Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Salmonella enterica, Shigella dysenteriae, and Vibrio parahaemolyticus. The data showed that the number of viable organisms remained within ±2 log10 of the original inoculum. This is consistent with the intended use of the predicate device and demonstrates substantial equivalence.
Performance was tested in two ways. Para-Fix Cary Blair Medium was tested for its ability to maintain enteric organisms using the plate count technique.
First Cary Blair vials were seeded with suspensions of enteric organisms in the absence of fecal matrix. Vials were held at 2-8°C and sampled at 0 and 96 hours by Swab Elution plate counts. Organisms were cultured on appropriate media to assure accurate recovery of seeded organisms. The performance criterion as specified by Clinical and Laboratory Standards Institute (CLSI), M40-A2 was met for the 10 enteric organisms previously listed.
Second, Para-Fix Cary Blair Medium was tested for its ability to maintain pathogenic enteric organisms spiked into clinically negative human fecal matrix. Clinically negative human fecal matrix was added to Cary Blair vials that were then seeded with suspensions of enteric organisms. Vials were held at 2-8°C and 20-25°C and sampled at 0, 72, 96 and 120 hours by serial dilution plate counts, and by the Roll-Plate method using sterile swabs (Fisher 23-400-122). Organisms were cultured on selective media to assure accurate recovery of seeded organisms. The performance criterion as specified by CLSI M40-A2 was met for Swab Elution or the Roll-Plate method.
Stability Testing: Para-Fix Cary Blair vials were tested for the products to maintain bacteria inocula on both newly manufactured vials and vials exceeding the expiration dating of 18 months, representing a worst-case condition with respect to shelf-life stability. Performance was assessed by determining the bacterial counts at the time of inoculation and 96 hours later. In all cases the bacterial counts were within ±2 log10, as specified in the performance criteria for this study. We conclude that Cary Blair Medium passes the performance criteria at the time of manufacture and after shelf-life expiration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The data showed that the number of viable organisms remained within ±2 log10 of the original inoculum.
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.
Meridian Para-Pak C&S K792712
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2015
Medical Chemical Corporation Kris Kontis, Ph.D. Vice President of Regulatory Affairs 19430 Van Ness Ave. Torrance, California 90501
Re: K141506
Trade/Device Name: MCC Para-Fix"M Cary Blair Medium Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: I Product Code: JSM, LIO Dated: January 22, 2015 Received: January 27 2015
Dear Dr. Kontis
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Stephen J. Lovell -S for
Sally Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141506
Device Name
MCC Para-Fix Cary Blair Medium
Indications for Use (Describe)
Para-FixTM Cary Blair Medium provides a method for collecting and preserving fecal specimens for the culture of intestinal enteric bacteria. Because the medium is capable of maintaining the bacteria for 96 hours, immediate transportation and processing of the specimen is not necessary.
Type of Use (Select one or both, as applicable) | |
---|---|
Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary ir Medium
Medical Chemical Corporation Para-Fix Cary Blair M | |
---|---|
Sponsor | |
Medical Chemical Corporation | |
19430 Van Ness Ave. | |
Torrance, California 90501-1104 | |
Contact: | Kris Kontis |
Telephone number | (800) 424-9394 |
Date: | January 22, 2015 |
Device Name | |
Trade Names: | MCC Para-Fix™ Cary Blair Medium |
Common Name: | Transport Vials |
Classification Name: | Culture Media, Non-Propagating Transport (JSM) |
Regulatory Information | |
Regulatory Section | 21 CFR 866.2390 |
Classification | Class I |
Product Code: | JSM, LIO |
Panel | Microbiology |
Predicate Device | |
Meridian Para-Pak C&S |
Device Description
510(k) Number:
Para-Fix Cary Blair Medium is a non-nutritive, buffered, isotonic solution with a pH indicator added. The medium also contains agar and sodium thioglycolate to maintain a low oxygen tension for the preservation of anaerobic species. The phenol red indicator will turn yellow when the solution is acidic and the conditions are not optimal for recovery of the intended organisms. Each 30 mL vial contains 15 ml of solution and a built in sample collection spoon. The kit is available with or without a multilingual instruction sheet and re-sealable bag.
Intended Use
Para-Fix Cary Blair Medium provides a method for collecting and preserving fecal specimens for the culture of intestinal enteric bacteria. Because the medium is capable of maintaining the bacteria for 96 hours, immediate transportation and processing of the specimen is not necessary.
Indication(s) for Use
Para-Fix Cary Blair Medium provides a method for collecting and preserving fecal specimens for the culture of intestinal enteric bacteria. Because the medium is capable of maintaining the bacteria for 96 hours, immediate transportation and processing of the specimen is not necessary.
Substantial Equivalence Statement
Medical Chemical Corporation Para-Fix Cary Blair media is similar in design, manufacturing and intended usage to the predicate device. Both the Para-Fix Cary Blair and the predicate device are single use devices intended for collection and transport of clinical specimens containing enteric organisms.
4
Device Comparison Table
Technical Attribute | Para-Fix Cary Blair (K141506) | Meridian Para-pak C&S (K792712) |
---|---|---|
Container | 30 mL Vial | 30 mL Vial |
Closure | Screw cap & spork | Screw cap & spork |
Vial pressure test | 95 kPa | unknown |
Formulation | Cary Blair | Cary Blair - modified |
Fill volume | 15 mL | 15 mL |
Storage temperature | 20-30°C | 20-30°C |
Buffer system | Phosphate | Phosphate |
Oxygen tension | Thioglycolate | Thioglycolate |
pH indicator | Phenol red | Phenol red |
Performance Testing
MCC Para-Fix Cary Blair Medium is intended to be used as a non-propagating preservative for fecal specimens being able to prevent the significant loss of organisms that may be pathogenic and to prevent the overgrowth by normal intestinal flora. The bacteriostasis study demonstrates that Para-Fix Cary Blair Medium preserves representative bacterial species for 96 hours at 2-8°C and 20-25°C. These species include potential pathogens that may be found in fecal samples: Campylobacter jejuni. Clostridium difficile, Enterococcus faecalis, Bacillus subtilis, Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Salmonella enterica, Shigella dysenteriae, and Vibrio parahaemolyticus. The data showed that the number of viable organisms remained within ±2 log10 of the original inoculum. This is consistent with the intended use of the predicate device and demonstrates substantial equivalence.
Performance was tested in two ways. Para-Fix Cary Blair Medium was tested for its ability to maintain enteric organisms using the plate count technique.
First Cary Blair vials were seeded with suspensions of enteric organisms in the absence of fecal matrix. Vials were held at 2-8°C and sampled at 0 and 96 hours by Swab Elution plate counts. Orqanisms were cultured on appropriate media to assure accurate recovery of seeded organisms. The performance criterion as specified by Clinical and Laboratory Standards Institute (CLSI), M40-A2 was met for the 10 enteric organisms previously listed. The results are shown in the following table:
5
All Enteric Organism recovery results for Para-Fix Cary Blair Medium using Swab Elution Method.
| Organism* | Hold Temperature | Average CFU's
Recovered:
Time 0 hrs | Average CFU's
Recovered:
Time 96 hrs | T=96 hrs Log
reduction (-) or
Log increase
(+) |
|-------------------------|------------------|-------------------------------------------|--------------------------------------------|---------------------------------------------------------|
| Escherichia coli | 2-8°C | 2.2x107 | 2.7x107 | +0.09 |
| | 20-25°C | 2.1x107 | 2.8x108 | +1.12 |
| Staphylococcus aureus | 2-8°C | 1.6x107 | 1.3 x107 | -0.09 |
| | 20-25°C | 1.5 x107 | 1.6 x107 | +0.03 |
| Pseudomonas aeruginosa | 2-8°C | 7.6x106 | 8.2x106 | +0.03 |
| | 20-25°C | 8.1x106 | 2.9x108 | +1.55 |
| Salmonella enterica | 2-8°C | 4.2x107 | 4.5x107 | +0.03 |
| | 20-25°C | 5.8x107 | 2.8x108 | +0.68 |
| Bacillus subtilis | 2-8°C | 4.0x106 | 4.4x106 | +0.04 |
| | 20-25°C | 4.7x106 | 1.5x107 | +0.50 |
| Vibrio parahaemolyticus | 2-8°C | 9.9x105 | 9.1x105 | -0.04 |
| | 20-25°C | 1.1x106 | 9.8x105 | -0.05 |
| Clostridium difficile | 2-8°C | 1.4x106 | 1.2x106 | -0.07 |
| | 20-25°C | 1.4x106 | 1.2x106 | -0.07 |
| Campylobacter jejuni | 2-8°C | 4.1x106 | 3.7x106 | -0.04 |
| | 20-25°C | 5.4x106 | 4.8x106 | -0.05 |
| Enterococcus faecalis | 2-8°C | 2.1x107 | 1.9x107 | -0.04 |
| | 20-25°C | 1.8x107 | 1.6x107 | -0.05 |
| Shigella dysenteriae | 2-8°C | 2.4x107 | 2.2x107 | -0.04 |
| | 20-25°C | 2.1x107 | 1.4x107 | -0.18 |
*0.5 McFarland microorganism suspension diluted with Cary Blair medium at 1:15
Second, Para-Fix Cary Blair Medium was tested for its ability to maintain pathogenic enteric organisms spiked into clinically negative human fecal matrix. Clinically negative human fecal matrix was added to Cary Blair vials that were then seeded with suspensions of enteric organisms. Vials were held at 2-8°C and 20-25°C and sampled at 0, 72, 96 and 120 hours by serial dilution plate counts, and by the Roll-Plate method using sterile swabs (Fisher 23-400-122). Organisms were cultured on selective media to assure accurate recovery of seeded organisms. The performance criterion as specified by CLSI M40-A2 was met for Swab Elution or the Roll-Plate method. The results are shown in the following tables:
6
Representative Enteric organism recovery results for Para-Fix™ Cary Blair Medium using Roll-Plate Method.
| Organism | Hold
Temperature | Average
CFU's
Recovered:
Time 0 hrs | Average
CFU's
Recovered:
Time 72
hrs | Average
CFU's
Recovered:
Time 96
hrs | Average
CFU's
Recovered:
Time 120
hrs | T=120 hrs
Log
reduction
(-) or Log
increase(+) |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------|----------------------------------------------|--------------------------------------------------|--------------------------------------------------|---------------------------------------------------|------------------------------------------------------------|
| Salmonella
enterica | 2-8°C | 220 | 140 | 160 | 130 | -0.23 |
| Salmonella
enterica | 20-25°C | 39 | ** | ** | 250 | +0.81 |
| Vibrio
parahaemolyticus | 2-8°C | 52 | 160 | 190 | 100 | +0.28 |
| Vibrio
parahaemolyticus | 20-25°C | 110 | ** | ** | ** | N/A |
| Escherichia
Coli | 2-8°C | 79 | 48 | 55 | 64 | -0.09 |
| Escherichia
Coli | 20-25°C | 75 | ** | ** | 150 | +0.30 |
| 0.5 McFarland microorganism suspension diluted with fecal matrix and Cary Blair medium to 2.04 unless
noted
- diluted 2.05 | | | | | | |
** Too numerous to count
Representative Enteric organism recovery results for Para-Fix™ Cary Blair Medium using Swab Elution Method.
| Organism | Hold
Temperature | Average
CFU's
Recovered:
Time 0 hrs | Average
CFU's
Recovered:
Time 72
hrs | Average
CFU's
Recovered:
Time 96
hrs | Average
CFU's
Recovered:
Time 120
hrs | T=120 hrs
Log
reduction
(-) or Log
increase
(+) |
|----------------------------|---------------------|----------------------------------------------|--------------------------------------------------|--------------------------------------------------|---------------------------------------------------|----------------------------------------------------------------|
| Salmonella
enterica | 2-8°C | 2.4x102 | 2.5 x102 | 2.8 x102 | 2.1 x102 | -0.06 |
| | 20-25°C | 8.0 x102 | ** | ** | ** | N/A |
| Vibrio
parahaemolyticus | 2-8°C | 2.9 x102 | 1.6x102 | 8.3x102 | 1.4x102 | -0.32 |
| | 20-25°C | 2.1 x102 | ** | ** | ** | N/A |
| Escherichia
coli | 2-8°C | 2.9 x102 | 1.6x102 | 5.2x102 | 6.4x101 | -0.66 |
| | 20-25°C | 1.2 x102 | 7.0 x102 | 5.2 x102 | 2.3 x102 | +0.28 |
*0.5 McFarland microorganism suspension diluted with fecal matrix and Cary Blair medium at 1:2000 ** Too numerous to count
Based on the comparison of technological attributes, functional testing of preservation ability, we conclude that MCC Para-Fix Cary Blair Medium is substantially equivalent to the predicate device -Meridian Para-Pak C&S.
Bioburden
MCC Para-Fix Cary Blair Medium was tested for the presence/absence of bioburden which could interfere with subsequent procedures. At the of manufacture bioburden was tested by an aerobic plate count. No viable organisms were found in any lots of product tested. A further test was performed after the end of expiration dating consisting of Gram staining each lot of product. No Gram-positive or Gram-negative organisms were detected by this method. We concluded that the process used to manufacture these media are effective at eliminating viable organisms and preventing the appearance of any organisms, viable or non-viable, that can be Gram stained
7
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Stability Testing
Para-Fix Cary Blair vials were tested for the products to maintain bacteria inocula on both newly manufactured vials and vials exceeding the expiration dating of 18 months, representing a worst-case condition with respect to shelf-life stability. Performance was assessed by determining the bacterial counts at the time of inoculation and 96 hours later. In all cases the bacterial counts were within ±2 log10, as specified in the performance criteria for this study. We conclude that Cary Blair Medium passes the performance criteria at the time of manufacture and after shelf-life expiration.
pH Stability
The pH value of the product at the time of testing was between 6.88 to 7.05 for Cary Blair Medium.
Sterilization
MCC Para-Fix Cary Blair Vials are not sold as sterile. Although there is no sterility claim, the manufacturing process includes treatment of finished vials in a steam chamber for 30 minutes to eliminate bioburden.