(264 days)
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.
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.
The provided text describes the acceptance criteria and a study demonstrating the performance of the MCC Para-Fix™ Cary Blair Medium device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The performance criterion as specified by Clinical and Laboratory Standards Institute (CLSI), M40-A2, is that the number of viable organisms remains within ±2 log10 of the original inoculum.
| Acceptance Criteria (CLSI M40-A2) | Reported Device Performance |
|---|---|
| Number of viable organisms must remain within ±2 log10 of the original inoculum after 96 hours of preservation. | Study 1: Enteric Organism Recovery (without fecal matrix)All 10 tested enteric organisms (Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella enterica, Bacillus subtilis, Vibrio parahaemolyticus, Clostridium difficile, Campylobacter jejuni, Enterococcus faecalis, Shigella dysenteriae) showed log changes within the ±2 log10 range at both 2-8°C and 20-25°C after 96 hours. The maximum observed log increase was +1.55 (Pseudomonas aeruginosa at 20-25°C), and the maximum observed log reduction was -0.18 (Shigella dysenteriae at 20-25°C). All these values are well within the ±2 log10 criterion.Study 2: Enteric Organism Recovery (with fecal matrix - Roll-Plate Method)For Salmonella enterica, Vibrio parahaemolyticus, and Escherichia Coli, the log changes at 120 hours were within the ±2 log10 range at both 2-8°C and 20-25°C. For organisms that were "Too numerous to count" (N/A in the table), it indicates growth, which would still meet the non-reduction criterion given the initial inoculum.Study 3: Enteric Organism Recovery (with fecal matrix - Swab Elution Method)For Salmonella enterica, Vibrio parahaemolyticus, and Escherichia Coli, the log changes at 120 hours were within the ±2 log10 range at both 2-8°C and 20-25°C. For organisms that were "Too numerous to count" (N/A in the table), it indicates growth, which would still meet the non-reduction criterion given the initial inoculum.Stability Testing:Bacterial counts after 96 hours were within ±2 log10 for both newly manufactured vials and vials exceeding the 18-month expiration dating. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size (Test Set): The document reports results for 10 distinct enteric organisms tested in various conditions (temperature, presence/absence of fecal matrix, and over different time points). For each condition, the "Average CFU's" are reported, implying multiple experimental replicates were performed, but the exact number of replicates for each organism and condition is not explicitly stated.
- Study 1 (without fecal matrix): 10 organisms, 2 temperatures (20 total conditions).
- Study 2 (with fecal matrix, Roll-Plate): 3 organisms, 2 temperatures (6 total conditions), sampled at 0, 72, 96, 120 hours.
- Study 3 (with fecal matrix, Swab Elution): 3 organisms, 2 temperatures (6 total conditions), sampled at 0, 72, 96, 120 hours.
- Data Provenance: The document does not specify the country of origin of the data. It appears to be a laboratory-based study conducted by Medical Chemical Corporation to support their 510(k) submission. It is a prospective study designed to assess the device's performance under specified conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the ground truth for this device (a transport medium) is based on quantitative microbiological assays (colony-forming unit - CFU counts), not expert interpretation of clinical data or images.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth is established objectively through laboratory assays and statistical analysis of CFU counts, not through expert consensus or arbitration.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a "Transport Culture Medium" and does not involve AI, human readers, or image interpretation. Its effectiveness is measured by its ability to preserve bacterial viability, not by improving human diagnostic performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medium for specimen transport, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for this study is quantitative microbiological data (CFU counts). This data directly measures the viability and growth/reduction of specific bacterial species under controlled experimental conditions, which is the direct performance metric for a transport medium. The criteria are based on CLSI standard M40-A2.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of a physical medical device like a transport medium. The studies described are performance validation studies.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device.
{0}------------------------------------------------
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
{2}------------------------------------------------
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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'sRecovered:Time 0 hrs | Average CFU'sRecovered:Time 96 hrs | T=96 hrs Logreduction (-) orLog 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 | HoldTemperature | AverageCFU'sRecovered:Time 0 hrs | AverageCFU'sRecovered:Time 72hrs | AverageCFU'sRecovered:Time 96hrs | AverageCFU'sRecovered:Time 120hrs | T=120 hrsLogreduction(-) or Logincrease(+) |
|---|---|---|---|---|---|---|
| Salmonellaenterica | 2-8°C | 220 | 140 | 160 | 130 | -0.23 |
| Salmonellaenterica | 20-25°C | 39 | ** | ** | 250 | +0.81 |
| Vibrioparahaemolyticus | 2-8°C | 52 | 160 | 190 | 100 | +0.28 |
| Vibrioparahaemolyticus | 20-25°C | 110 | ** | ** | ** | N/A |
| EscherichiaColi | 2-8°C | 79 | 48 | 55 | 64 | -0.09 |
| EscherichiaColi | 20-25°C | 75 | ** | ** | 150 | +0.30 |
| 0.5 McFarland microorganism suspension diluted with fecal matrix and Cary Blair medium to 2.04 unlessnoted* diluted 2.05 |
** Too numerous to count
Representative Enteric organism recovery results for Para-Fix™ Cary Blair Medium using Swab Elution Method.
| Organism | HoldTemperature | AverageCFU'sRecovered:Time 0 hrs | AverageCFU'sRecovered:Time 72hrs | AverageCFU'sRecovered:Time 96hrs | AverageCFU'sRecovered:Time 120hrs | T=120 hrsLogreduction(-) or Logincrease(+) |
|---|---|---|---|---|---|---|
| Salmonellaenterica | 2-8°C | 2.4x102 | 2.5 x102 | 2.8 x102 | 2.1 x102 | -0.06 |
| 20-25°C | 8.0 x102 | ** | ** | ** | N/A | |
| Vibrioparahaemolyticus | 2-8°C | 2.9 x102 | 1.6x102 | 8.3x102 | 1.4x102 | -0.32 |
| 20-25°C | 2.1 x102 | ** | ** | ** | N/A | |
| Escherichiacoli | 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}------------------------------------------------
{8}------------------------------------------------
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.
§ 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).