(57 days)
Not Found
No
The device is a chemical medium for preserving fecal specimens and does not involve any computational analysis or algorithms.
No
The device is designed for the collection and preservation of fecal specimens for diagnostic purposes (culture of intestinal enteric bacteria), not for treating a condition or disease.
No.
The device is a collection and preservation medium for fecal specimens, designed to maintain the viability of intestinal enteric bacteria for subsequent culture, not to diagnose.
No
The device is a physical medium for collecting and preserving fecal specimens, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "collecting and preserving fecal specimens for the culture of intestinal enteric bacteria." This directly relates to the examination of specimens derived from the human body (fecal specimens) to provide information for the diagnosis of disease (identifying intestinal enteric bacteria which can cause illness).
- Device Description: The device is a medium designed to maintain the viability of bacteria in a specimen for subsequent laboratory testing (culture). This is a key characteristic of devices used in in vitro diagnostic procedures.
- Performance Studies: The performance studies described involve testing the ability of the medium to preserve bacterial viability in fecal specimens, which is a crucial aspect of ensuring accurate diagnostic results from subsequent culture.
- Predicate Device: The predicate device listed (Meridian Para-Pak C&S) is also a device used for collecting and preserving fecal specimens for culture, further indicating that this type of device falls under the category of IVDs.
Therefore, based on its intended use, function, and the context of its performance evaluation and predicate device, the Para-Fix™ C&S Medium is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Para-Fix C&S 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 C&S 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
Fecal specimens (intestinal enteric bacteria)
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
MCC Para-Fix C&S Medium was tested for its ability to maintain enteric organisms using the plate count technique.
First C&S vials were seeded with suspensions of enteric organisms in the absence of fecal matrix. Vials were held at 2-8°C and 20-25°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 Cinical and Laboratory Standards Institute (CLSI), M40-A2 was met for the 10 enteric organisms previously listed.
Second, Para-Fix C&S 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 C&S vials that were then seeded with suspensions of enteric organisms. Vials were held at 2-8℃ 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)
Performance Testing:
MCC Para-Fix C&S 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 C&S 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 C&S vials were seeded with suspensions of enteric organisms in the absence of fecal matrix. Vials were held at 2-8°C and 20-25°C and sampled at 0 and 96 hours by Swab Elution plate counts. Organisms were cultured on appropriate media. The performance criterion as specified by CLSI, M40-A2 was met for the 10 enteric organisms listed.
Sample size: Not explicitly stated for each organism in study 1, but counts are given for 10 organisms.
Results: The tables show "Average CFU's Recovered" at Time 0 hrs and Time 96 hrs, and "T=96 hrs Log reduction/Log increase" for various organisms at 2-8°C and 20-25°C. All log changes were within ±2 log10. -
Para-Fix C&S 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 C&S vials that were then seeded with suspensions of enteric organisms. Vials were held at 2-8℃ 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. Organisms were cultured on selective media. The performance criterion as specified by CLSI M40-A2 was met for Swab Elution or the Roll-Plate method.
Sample size: Not explicitly stated for each organism in study 2.
Results: Tables show "Average CFU's Recovered" at Time 0 hrs, Time 72 hrs, Time 96 hrs, and Time 120 hrs, and "T=120 hrs log reduction(-) or log increase (+)" for selected organisms (Salmonella enterica, Vibrio parahaemolyticus, Escherichia coli) using Roll-Plate and Swab Elution methods. Most 20-25°C samples resulted in "Too numerous to count" by 72/96/120 hrs.
Bioburden: MCC Para-Fix C&S Medium was tested for the presence/absence of bioburden. At the time of manufacture, bioburden was tested by an aerobic plate count; no viable organisms were found. A further test after expiration dating involved Gram staining; no Gram-positive or Gram-negative organisms were detected.
Stability Testing: Para-Fix C&S vials were tested to maintain bacteria inocula on both newly manufactured vials and vials exceeding the expiration dating of 18 months. Performance was assessed by determining bacterial counts at inoculation and 96 hours later. In all cases, bacterial counts were within ±2 log10.
pH Stability: pH value of the product at the time of testing was between 7.08 to 7.83 for Para-Fix C&S Medium.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 510(k) Number: 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 28, 2015
MEDICAL CHEMICAL CORPORATION KRIS KONTIS VP REGULATORY AFFAIRS 19430 VAN NESS AVE TORRANCE CA 90501-1104
Re: K150887
Trade/Device Name: Para-fix C&S Medium Regulation Number: 21 CFR 866.2390 Regulation Name: Transport culture medium Regulatory Class: I Product Code: JSM, LIO Dated: March 30, 2015 Received: April 3, 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,
Sally A. Hojvat -S
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
2
Indications for Use
510(k) Number (if known) K150887
Device Name
MCC Para-Fix C&S Medium
Indications for Use (Describe)
Para-Fix™ C&S 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 Medical Chemical Corporation Para-Fix C&S Medium
Sponsor Medical Chemical Corporation 19430 Van Ness Ave. Torrance, California 90501-1104 Contact: Kris Kontis Telephone number (800) 424-9394 Date: March 24, 2015
Device Name
Trade Names: MCC Para-Fix™ C&S Medium Common Name: Transport Vials Classification Name: Culture Media, Non-Propagating Transport (JSM)
Requlatory Information
Regulatory Section 21 CFR 866.2390 Classification Class I Product Code: JSM, LIO Panel Microbiology
Predicate Device
Meridian Para-Pak C&S 510(k) Number: K792712
Device Description
Para-Fix C&S 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 C&S 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 C&S 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 C&S medium is similar in design, manufacturing and intended usage to the predicate device. Both the Para-Fix C&S 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 C&S (K150887) | 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 - modified | 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 C&S 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 C&S 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 C&S Medium was tested for its ability to maintain enteric organisms using the plate count technique.
First C&S wials were seeded with suspensions of enteric orqanisms in the absence of fecal matrix. Vials were held at 2-8°C and 20-25°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 Cinical 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 C&S 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/
Log increase |
|---------------------------|---------------------|-------------------------------------------|--------------------------------------------|--------------------------------------------|
| Escherichia coli | 2-8°C | 1.6 X 107 | 5.1 X 107 | 0.51 |
| Escherichia coli | 20-25°C | 2.1 X 107 | 2.5 X 106 | 1.09 |
| Staphylococcus aureus | 2-8°C | 1.6 X 107 | 1.4 X 107 | -0.04 |
| Staphylococcus aureus | 20-25°C | 1.5 X 107 | 2.4 X 107 | 0.20 |
| Pseudomonas
aeruginosa | 2-8°C | 8.1 X 106 | 6.2 X 106 | -0.12 |
| Pseudomonas
aeruginosa | 20-25°C | 9.2 X 106 | 2.0 X 106 | 1.34 |
| Salmonella enterica | 2-8°C | 6.1 X 107 | 5.8 X 107 | -0.02 |
| Salmonella enterica | 20-25°C | 5.6 X 107 | 2.1 X 106 | 0.57 |
| Bacillus subtilis | 2-8°C | 3.6 X 106 | 4.0 X 106 | 0.04 |
| Bacillus subtilis | 20-25°C | 4.6 X 106 | 1.6 X 107 | 0.54 |
| Vibrio parahaemolyticus | 2-8°C | 9.8 X 106 | 8.9 X 106 | -0.04 |
| Vibrio parahaemolyticus | 20-25°C | 9.8 X 106 | 8.8 X 106 | -0.05 |
| Clostridium difficile | 2-8°C | 1.2 X 107 | 1.0 X 107 | -0.06 |
| Clostridium difficile | 20-25°C | 1.1 X 107 | 9.5 X 106 | -0.06 |
| Campylobacter jejuni | 2-8°C | 5.8 X 107 | 5.0 X 107 | -0.07 |
| Campylobacter jejuni | 20-25°C | 4.0 X 107 | 3.5 X 107 | -0.06 |
| Enterococcus faecalis | 2-8°C | 2.3 X 107 | 2.1 X 107 | -0.04 |
| Enterococcus faecalis | 20-25°C | 2.2 X 107 | 1.8 X 107 | -0.10 |
| Shigella dysenteriae | 2-8°C | 2.2 X 107 | 1.4 X 107 | -0.19 |
| Shigella dysenteriae | 20-25°C | 2.4 X 107 | 5.1 X 106 | -0.68 |
*0.5 McFarland microorganism suspension diluted with C&S Medium at 1:15
Second, Para-Fix C&S 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 C&S vials that were then seeded with suspensions of enteric organisms. Vials were held at 2-8℃ 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™ C&S 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 | 190 | 192 | 162 | 97 | -0.29 |
| enterica | 20-25°*C | 64 | ** | ** | ** | N/A |
| Vibrio
parahaemolyticus | 2-8°C | 220 | 160 | 63 | 68 | -0.51 |
| parahaemolyticus | 20-25°C | 130 | ** | ** | ** | N/A |
| Escherichia
coli | 2-8°C | 110 | 48 | 83 | 71 | -0.19 |
| coli | 20-25°C | 70 | ** | ** | ** | N/A |
| 0.5 McFarland microorganism suspension diluted with fecal matrix and C&S Medium to 2.0 X 104 unless | | | | | | |
| noted | | | | | | |
| * diluted 2.0 X 105 | | | | | | |
| ** Too numerous to count | | | | | | |
Representative Enteric organism recovery results for Para-Fix™ C&S 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 | 2.7 X 102 | 2.9 X 102 | 3.0 X 102 | 2.0 X 102 | -0.13 |
| | 20-25°C | 3.2 X 102 | ** | ** | ** | N/A |
| Vibrio
parahaemolyticus | 2-8°C | 2.2 X 102 | 1.6 X 102 | 6.3 X 102 | 6.8 X 102 | +0.49 |
| | 20-25°C | 2.5 X 102 | ** | ** | ** | N/A |
| Escherichia
coli | 2-8°C | 1.6 X 102 | 8.9 X 101 | 1.3 X 102 | 9.4 X 101 | -0.23 |
| | 20-25°C | 1.0 X 102 | 6.8 X 102 | 5.4 X 102 | 7.6 X 102 | +0.88 |
| *0.5 McFarland microorganism suspension diluted with fecal matrix and C&S 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 C&S Medium is substantially equivalent to the predicate device - Meridian Para-Pak C&S.
Bioburden
MCC Para-Fix C&S Medium was tested for the presence/absence of bioburden which could interfere with subsequent procedures. At the time 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
Stability Testing
Para-Fix C&S 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 logio, as specified in the performance criteria for this study. We conclude that C&S 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 7.08 to 7.83 for Para-Fix C&S Medium.
Sterilization
MCC Para-Fix C&S vials are not sold as sterile. Although there is no sterlity claim, the manufacturing process includes treatment of finished vials in a steam chamber for 30 minutes to eliminate bioburden.