(50 days)
Not Found
No
The 510(k) summary describes a collection, transport, and preservation system for biological specimens. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The performance studies focus on the viability of organisms in the transport medium and the physical properties of the device.
No
The device is a collection, transport, and preservation system for clinical specimens, designed to maintain the viability of bacteria and viruses for testing in a laboratory, not to treat a condition or disease.
No
The MSwab is a collection, transport, and preservation system for specimens. It is not used to diagnose a condition, but rather to ensure the integrity of samples until they reach a testing laboratory for diagnostic processing.
No
The device description clearly outlines physical components including plastic tubes, screw-caps, transport medium, and specimen collection swabs. The performance studies also focus on the physical and biological properties of these components (recovery, stability, pH, sterilization, biocompatibility, cytotoxicity). There is no mention of software as a component or function of this device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "collection and transport of clinical specimens containing Gram positive aerobic and facultative anaerobic bacteria, HSV 1 and HSV 2 from the collection site to the testing laboratory." It also states that in the laboratory, the specimens are "processed using standard clinical laboratory operating procedures for culture." This clearly indicates the device is used in the collection and preparation of samples for in vitro diagnostic testing (culture).
- Device Description: The description details a "Collection, Transport and Preservation System" designed to "maintain the viability" of specific microorganisms during transit to the "testing laboratory." This function is directly related to ensuring the quality of a sample for subsequent diagnostic testing.
- Performance Studies: The performance studies described are focused on "Recovery studies" to determine the ability of the product to "maintain viability" of various bacterial and viral strains. These studies are conducted to demonstrate the device's suitability for its intended diagnostic purpose.
- Predicate Devices: The predicate devices listed (Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System and Copan Universal Transport Medium (UTM-RT) System) are also collection and transport systems for clinical specimens intended for laboratory testing, which are typically classified as IVDs.
While the device itself doesn't perform the diagnostic test (culture), it is an essential component in the pre-analytical phase of an in vitro diagnostic procedure. The collection and transport of the specimen are critical steps that directly impact the accuracy and reliability of the subsequent diagnostic test results. Therefore, the MSwab system falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
MSwab is a Collection, Transport and Preservation System intended for the collection and transport of clinical specimens containing Gram positive aerobic and facultative anaerobic bacteria, HSV 1 and HSV 2 from the collection site to the testing laboratory. In the laboratory, MSwab specimens are processed using standard clinical laboratory operating procedures for culture.
Product codes (comma separated list FDA assigned to the subject device)
JTW (System, Transport, Aerobic), JTX (Transport Systems, Anaerobic)
Device Description
Copan MSwab Collection, Transport and Preservation System is supplied in two different formats: a collection kit format and a tube only format. Each collection kit consists of a package containing a plastic screw-cap tube with conical shaped bottom filled with 1 ml or 1.6 ml of MSwab transport and preservation medium and a small sterile peel pouch containing one specimen collection swab that has a tip flocked with soft nylon fiber. The tube only format consists of a plastic screw-cap tube with conical shaped bottom filled with 1 ml or 1.6 ml of MSwab transport and preservation medium. The MSwab is intended for single use.
MSwab transport and preservation medium is a maintenance medium comprising TRIS HCl. EDTA. TRIS Base, Dimethyl Sulfoxide (DMSO) and Bovine Serum Albumin. The medium is designed to maintain the viability of Gram positive aerobic and facultative anaerobic bacteria. HSV 1 and HSV 2 during transit to the testing laboratory.
The nylon flocked specimen collection swab provided in each collection kit of the Copan MSwab Collection. Transport and Preservation System has a solid plastic shaft with a molded breakpoint site.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Recovery Studies: Recovery studies were performed using the Copan MSwab and the predicate devices to determine the ability of the products to maintain viability of various strains of Gram positive aerobic and facultative anaerobic bacteria. HSV 1 and HSV 2. The Gram positive aerobic and facultative anaerobic bacteria included in the recovery studies were: Streptococcus pyogenes ATCC 19615, Streptococcus pneumoniae ATCC 6305, Streptococcus pneumoniae ATCC 49136, Enterococcus faecalis ATCC 29212, Staphylococcus epidermidis ATCC 12228, Staphylococcus aureus ATCC 29213, Streptococcus agalactiae (Group B Strep) ATCC 13813, Kocuria rhizophila ATCC 9341, Listeria monocytogenes ATCC 19114, Bacillus cereus ATCC 10876, Staphylococcus aureus (Methicillin resistant) ATCC 43300, Staphylococcus aureus ATCC 6538, Staphylococcus aureus (Methicillin resistant) ATCC 700698. The viruses included in the recovery studies were: ATCC VR-539 Hernes Simnlex Virus Type 1 (HSV 1), Herpes Simplex Virus Type 1 (HSV-1) ATCC VR-733, Herpes Simplex Virus Type 2 (HSV 2) ATCC VR-734.
The recovery studies were performed using the Copan MSwab and the predicate devices for all organisms at two different temperature ranges, 4-8℃ and 20-25℃, corresponding to refrigerator and room temperature, respectively. Swabs accompanying each transport system were inoculated in triplicate with 100 ul of specific concentrations of organism suspension. Swabs were then placed in their respective transport medium tubes and were held for 0, 24 and 48 hours. Viability performance was determined for each test organism at the 48 hours time point compared to the 0 hour time point.
For the bacterial recovery studies, each swab was processed according to the swab elution or roll-plate method at the appropriate time intervals. Acceptable recovery for the swab elution method was defined as no more than a 3 log10 (1 x 10 +/- 10%) decline in CFU between the CFU count at 0 hour and the CFU count at 48 hours. Acceptable recovery for the roll-plate method was defined as >5 CFU at 48 hours from the specific dilution that yielded 0 hour counts closest to 300 CFU.
For the viral recovery studies, each swab was vortexed and removed from its transport medium tube at the appropriate time interval. 200ul aliquots of the suspension in the medium tube were inoculated into shell vials. All cultures were processed by standard laboratory culture technique and examined after a specified incubation time. Organism viability was determined by fluorescing foci counts. Acceptable recovery was defined as any viral recovery at 48 hours.
Viral recovery studies also were performed using the Copan MSwab and the predicate Copan UTM-RT for samples stored at -70℃ for 14 days. Acceptable recovery was defined as any viral recovery at 14 days.
Key results: The results of the recovery studies demonstrate the ability of the Copan MSwab Collection, Transport and Preservation System to maintain the viability of all bacterial strains evaluated for at least 48 hours at temperatures of 4-8°C and 20-25°C, and the viability of all viral strains evaluated for at least 48 hours at temperatures of 4-8℃ and 20-25℃, and for at least 14 days at a temperature of -70°C.
Recovery Stability: Recovery studies were performed using aged MSwab System devices at specified time intervals up to 13 months following the date of manufacture. The bacteria and viruses selected for the stability testing were: Streptococcus pyogenes ATCC 19615, Streptococcus pneumoniae ATCC 6305, Staphylococcus aureus (Methicillin resistant) ATCC 43300, Herpes Simplex Virus Type 1 (HSV 1) ATCC VR-539, Herpes Simplex Virus Type 2 (HSV 2) ATCC VR-734. The recovery stability studies were performed at two different temperature ranges, 4-8°C and 20-25°C. Viability performance was determined for each test organism at the 48 hours time point compared to the 0 hour time point. The results from three representative lots demonstrated the ability of the MSwab System to maintain the viability of the bacterial and viral strains evaluated for at least 13 months following the date of manufacture.
pH Stability: The pH of MSwab medium was measured at specified time intervals up to 13 months following the date of manufacture. The results from three representative lots demonstrated the ability to maintain pH within the target range at all time intervals tested.
Biocompatibility: The nylon flocked swab component of the MSwab System was tested in accordance with ISO 10993, "Biological Evaluation of Medical Devices." The results demonstrated that the swab component is non-cytotoxic, non-irritating and non-sensitizing.
Cytotoxicity: Testing was performed to evaluate the cytotoxicity of the MSwab System using an MRC5 cell line. The results from three representative lots aged 1 month, 7 months and 13 months showed no alteration of the cell monolayers compared to the negative control.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Log decline recorded for bacterial studies, average foci of infected cells and log decline for viral studies. Acceptable recovery means no more than a 3 log10 (1 x 10 +/- 10%) decline in CFU between the CFU count at 0 hour and the CFU count at 48 hours for swab elution method, >5 CFU at 48 hours for roll-plate method, and any viral recovery at 48 hours or 14 days for viral studies.
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.
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
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
510(k) Summary for
MAY 2 5 2012
K121039
Copan MSwab Collection, Transport and Preservation System
(per 21 CFR 807.92 and http://www.fda.gov/MedicalDeviceRegulationandGuidance/default.htm)
1. APPLICANT/SPONSOR
Copan Flock Technologies S.r.l. Via F. Perotti 16-18 25125 Brescia, Italy
| Contact Person: | Alberto Poli |
|---|---|
| Telephone: | +39 030 2687290 |
| FAX: | +39 030 2687250 |
May 22, 2012 Date Prepared:
2. DEVICE NAME AND REGULATORY INFORMATION
| Proprietary Name: | Copan MSwab Collection, Transport and Preservation System |
|---|---|
| Common/Usual Name: | Collection and Transport Device |
| Classification Name: | Microbiological Specimen Collection and Transport Device |
| Regulation Section: | 21 CFR 866.2900 |
| Classification: | Class I |
| Product Codes: | JTW (System, Transport, Aerobic) |
| JTX (Transport Systems, Anaerobic) | |
| Panel: | Microbiology |
3. PREDICATE DEVICES
- · Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System Copan Diagnostics Inc. K061301
- · Copan Universal Transport Medium (UTM-RT) System Copan Diagnostics Inc. K042970
4. DEVICE DESCRIPTION
Copan MSwab Collection, Transport and Preservation System is supplied in two different formats: a collection kit format and a tube only format. Each collection kit consists of a
l
1
package containing a plastic screw-cap tube with conical shaped bottom filled with 1 ml or 1.6 ml of MSwab transport and preservation medium and a small sterile peel pouch containing one specimen collection swab that has a tip flocked with soft nylon fiber. The tube only format consists of a plastic screw-cap tube with conical shaped bottom filled with 1 ml or 1.6 ml of MSwab transport and preservation medium. The MSwab is intended for single use.
MSwab transport and preservation medium is a maintenance medium comprising TRIS HCl. EDTA. TRIS Base, Dimethyl Sulfoxide (DMSO) and Bovine Serum Albumin. The medium is designed to maintain the viability of Gram positive aerobic and facultative anaerobic bacteria. HSV 1 and HSV 2 during transit to the testing laboratory.
The nylon flocked specimen collection swab provided in each collection kit of the Copan MSwab Collection. Transport and Preservation System has a solid plastic shaft with a molded breakpoint site.
5. INTENDED USE/INDICATIONS FOR USE
MSwab is a Collection, Transport and Preservation System intended for the collection and transport of clinical specimens containing Gram positive aerobic and facultative anaerobic bacteria, HSV 1 and HSV 2 from the collection site to the testing laboratory. In the laboratory, MSwab specimens are processed using standard clinical laboratory operating procedures for culture.
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES
The Copan MSwab products are substantially equivalent to the predicate specimen collection and transport devices. The Copan MSwab products and the predicate devices are similar in intended use and overall function.
The proposed and predicate devices are single-use products intended for the collection and transport of clinical specimens containing bacteria in the case of the Copan ESwab System and viruses in the case of the Copan UTM-RT System. Both the Copan MSwab and the predicate devices are offered in collection kit formats with specimen collection swab options.
2 .
2
| - RECOMMENDATIONS FOR DEALING WITH "BAD" BEHAVIOR. |
|---|
| - KNOW YOURSELF. What "pushes your buttons"? What behaviors do you find most annoying? |
- KNOW THE CHILD. What are the child's strengths? What are the child's needs? What is the child trying to communicate through his/her behavior?
- KNOW THE CONTEXT. What is happening in the classroom? What is happening at home? What is happening in the child's life?
- KNOW THE LAW. What are the legal requirements for dealing with "bad" behavior? What are the ethical considerations? |
. .
| Item | Copan MSwab System
(Bacteriology and Virology Claims) | Copan ESwab System
(Predicate for Bacteriology Claim) | Copan UTM-RT System
(Predicate for Virology Claim) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | MSwab is a Collection, Transport and Preservation System intended for the collection and transport of clinical specimens containing Gram positive aerobic and facultative anaerobic bacteria, HSV 1 and HSV 2 from the collection site to the testing laboratory. In the laboratory, MSwab specimens are processed using standard clinical laboratory operating procedures for culture. | Copan Liquid Amies Elution Swab (ESwab) Collection and Transport System is intended for the collection and transport of clinical specimens containing aerobes, anaerobes and fastidious bacteria from the collection site to the testing laboratory. In the laboratory, ESwab specimens are processed using standard clinical laboratory operating procedures for bacterial culture. | Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasma or ureaplasma from the collection site to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture. |
| Microorganisms
Supported | Gram positive aerobic and facultative anaerobic bacteria, HSV 1 and HSV 2 | Aerobic, anaerobic and fastidious bacteria | Viruses, chlamydiae, mycoplasma and ureaplasma |
| Medium Formulation | TRIS HCL
EDTA
TRIS Base
DMSO
Bovine Serum Albumin
Distilled water | Sodium chloride
Potassium chloride
Calcium chloride
Magnesium chloride
Monopotassium phosphate
Disodium phosphate
Sodium thioglycollate
Distilled water | Hank's Balanced Salts
Bovine Serum Albumin
L-Cysteine
Gelatin
Sucrose
L-Glutamic Acid
HEPES Buffer
Vancomycin
Amphotericin B
Colistin
Phenol Red |
| Storage Temperature | 5-25°C | 5-25°C | 2-25°C |
| Container for Medium | Tube; Plastic, conical bottom | Tube; Plastic, conical bottom | Tube; Plastic, conical bottom |
| Product Configuration | Medium in Tube with Cap;
Kit with Medium and Swab in Peel Pouch
Options | Kit with Medium and Swab in Peel Pouch
Options | Medium in Tube with Cap;
Kit with Medium and Swab in Peel Pouch
Options |
| Swab Tip | Flocked nylon | Flocked nylon | Polyester |
3
7. STANDARD/GUIDANCE DOCUMENTS REFERENCED
- · Clinical and Laboratory Standards Institute (CLSI) document M40-A, Vol. 23, No. 34, "Ouality Control of Microbiological Transport Systems: Approved Standard
- · FDA/CDRH General Program Memorandum G95-1. Use of International Standard ISO-10993. "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". (May 1. 1995)
8. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Recovery Studies: Recovery studies were performed using the Copan MSwab and the predicate devices to determine the ability of the products to maintain viability of various strains of Gram positive aerobic and facultative anaerobic bacteria. HSV 1 and HSV 2.
The Gram positive aerobic and facultative anaerobic bacteria included in the recovery studies were:
| Streptococcus pyogenes | ATCC 19615 |
|---|---|
| Streptococcus pneumoniae | ATCC 6305 |
| Streptococcus pneumoniae | ATCC 49136 |
| Enterococcus faecalis | ATCC 29212 |
| Staphylococcus epidermidis | ATCC 12228 |
| Staphylococcus aureus | ATCC 29213 |
| Streptococcus agalactiae (Group B Strep) | ATCC 13813 |
| Kocuria rhizophila | ATCC 9341 |
| Listeria monocytogenes | ATCC 19114 |
| Bacillus cereus | ATCC 10876 |
| Staphylococcus aureus (Methicillin resistant) | ATCC 43300 |
| Staphylococcus aureus | ATCC 6538 |
| Staphylococcus aureus (Methicillin resistant) | ATCC 700698 |
The viruses included in the recovery studies were: ATCC VR-539 Hernes Simnlex Virus Type 1 (HSV 1)
| Herpes Simplex Virus Type 1 (HSV-1) | ATCC VR-733 |
|---|---|
| Herpes Simplex Virus Type 2 (HSV 2) | ATCC VR-734 |
The recovery studies were performed using the Copan MSwab and the predicate devices for all organisms at two different temperature ranges, 4-8℃ and 20-25℃, corresponding to refrigerator and room temperature, respectively. Swabs accompanying each transport system were inoculated in triplicate with 100 ul of specific concentrations of organism suspension. Swabs were then placed in their respective transport medium tubes and were held for 0, 24
4
and 48 hours. Viability performance was determined for each.test organism at the 48 hours time point compared to the 0 hour time point.
For the bacterial recovery studies, each swab was processed according to the swab elution or roll-plate method at the appropriate time intervals. Acceptable recovery for the swab elution method was defined as no more than a 3 log10 (1 x 10 +/- 10%) decline in CFU between the CFU count at 0 hour and the CFU count at 48 hours. Acceptable recovery for the roll-plate method was defined as >5 CFU at 48 hours from the specific dilution that yielded 0 hour counts closest to 300 CFU. The results of the bacterial recovery studies for the Copan MSwab System are presented in Tables 1 through 4.
For the viral recovery studies, each swab was vortexed and removed from its transport medium tube at the appropriate time interval. 200ul aliquots of the suspension in the medium tube were inoculated into shell vials. All cultures were processed by standard laboratory culture technique and examined after a specified incubation time. Organism viability was determined by fluorescing foci counts. Acceptable recovery was defined as any viral recovery at 48 hours. The results of the viral recovery studies for the Copan MSwab System are presented in Tables 5 and 6.
Viral recovery studies also were performed using the Copan MSwab and the predicate Copan UTM-RT for samples stored at -70℃ for 14 days. Acceptable recovery was defined as any viral recovery at 14 days. The results demonstrated acceptable recovery for all samples tested.
The results of the recovery studies demonstrate the ability of the Copan MSwab Collection, Transport and Preservation System to maintain the viability of all bacterial strains evaluated for at least 48 hours at temperatures of 4-8°C and 20-25°C, and the viability of all viral strains evaluated for at least 48 hours at temperatures of 4-8℃ and 20-25℃, and for at least 14 days at a temperature of -70°C.
5
TABLE 1. SUMMARY OF RESULTS FOR BACTERIAL RECOVERY STUDIES
SWAB ELUTION METHOD, 4-8°C
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•
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| Organism | Dilution:
0.5 McFarland
bacterial
suspension with
saline | Product | Lot Number | Average of
CFUs recovered
at time
0 hrs | Average of
CFUs recovered
at time
24 hrs | Average of
CFUs recovered
at time
48 hrs | Log
decline | Interpretation |
|-------------------------------------------------------|----------------------------------------------------------------------|---------|------------|--------------------------------------------------|---------------------------------------------------|---------------------------------------------------|------------------------|------------------------|
| Streptococcus
pyogenes
ATCC 19615 | diluted
1:10 | MSwab | 2045 | $3.9 x 10^5$ | $2.7 x 10^5$ | $2.3 x 10^5$ | -0.23 | Acceptable
Recovery |
| | | | 2045/1 | $4.8 x 10^5$ | $2.5 x 10^5$ | $2.1 x 10^5$ | -0.36 | Acceptable
Recovery |
| | | | 2045/2 | $4.2 x 10^5$ | $2.3 x 10^5$ | $2.0 x 10^5$ | -0.32 | Acceptable
Recovery |
| Streptococcus
pneumoniae
ATCC 6305 | diluted
1:10 | MSwab | 2045 | $1.2 x 10^5$ | $1.8 x 10^4$ | $2.1 x 10^3$ | -1.76 | Acceptable
Recovery |
| | | | 2045/1 | $1.2 x 10^5$ | $1.9 x 10^4$ | $1.7 x 10^3$ | -1.85 | Acceptable
Recovery |
| | | | 2045/2 | $1.2 x 10^5$ | $2.0 x 10^4$ | $1.9 x 10^3$ | -1.80 | Acceptable
Recovery |
| Streptococcus
pneumoniae
ATCC 49136 | diluted
1:10 | MSwab | 2045 | $2.0 x 10^5$ | $2.0 x 10^3$ | $2.1 x 10^3$ | -1.98 | Acceptable
Recovery |
| | | | 2045/1 | $1.8 x 10^5$ | $2.1 x 10^4$ | $1.8 x 10^3$ | -2.00 | Acceptable
Recovery |
| | | | 2045/2 | $1.9 x 10^5$ | $1.8 x 10^4$ | $1.7 x 10^3$ | -2.05 | Acceptable
Recovery |
| Enterococcus faecalis
ATCC 29212 | diluted
1:10 | MSwab | 2045 | $1.1 x 10^6$ | $1.0 x 10^6$ | $9.4 x 10^5$ | -0.07 | Acceptable
Recovery |
| | | | 2045/1 | $1.1 x 10^6$ | $1.0 x 10^6$ | $9.2 x 10^5$ | -0.08 | Acceptable
Recovery |
| | | | 2045/2 | $1.1 x 10^6$ | $1.0 x 10^6$ | $9.5 x 10^5$ | -0.06 | Acceptable
Recovery |
| Staphylococcus
epidermidis
ATCC 12228 | diluted
1:10 | MSwab | 2045 | $1.6 x 10^6$ | $1.2 x 10^6$ | $9.2 x 10^5$ | -0.24 | Acceptable
Recovery |
| | | | 2045/1 | $1.7 x 10^6$ | $1.3 x 10^6$ | $1.1 x 10^6$ | -0.19 | Acceptable
Recovery |
| | | | 2045/2 | $1.4 x 10^6$ | $1.2 x 10^6$ | $9.5 x 10^5$ | -0.17 | Acceptable
Recovery |
| Staphylococcus aureus
ATCC 29213 | diluted
1:10 | MSwab | 2045 | $1.3 x 10^6$ | $1.0 x 10^6$ | $8.8 x 10^5$ | -0.17 | Acceptable
Recovery |
| | | | 2045/1 | $1.0 x 10^6$ | $9.5 x 10^5$ | $7.4 x 10^5$ | -0.13 | Acceptable
Recovery |
| | | | 2045/2 | $1.0 x 10^6$ | $9.5 x 10^5$ | $8.0 x 10^5$ | -0.10 | Acceptable
Recovery |
| Streptococcus agalactiae
ATCC 13813 | diluted
1:10 | MSwab | 2045 | $2.1 x 10^6$ | $1.8 x 10^6$ | $1.5 x 10^6$ | -0.15 | Acceptable
Recovery |
| | | | 2045/1 | $1.9 x 10^6$ | $1.8 x 10^6$ | $1.5 x 10^6$ | -0.10 | Acceptable
Recovery |
| | | | 2045/2 | $2.2 x 10^6$ | $1.4 x 10^6$ | $1.3 x 10^6$ | -0.23 | Acceptable
Recovery |
| Kocuria rhizophila
ATCC 9341 | diluted
1:10 | MSwab | 2045 | $2.0 x 10^5$ | $1.5 x 10^5$ | $1.4 x 10^5$ | -0.15 | Acceptable
Recovery |
| | | | 2045/1 | $2.1 x 10^5$ | $1.4 x 10^5$ | $1.4 x 10^5$ | -0.18 | Acceptable
Recovery |
| | | | 2045/2 | $2.2 x 10^5$ | $1.6 x 10^5$ | $1.4 x 10^5$ | -0.19 | Acceptable
Recovery |
| Listeria monocytogenes
ATCC 19114 | diluted
1:10 | MSwab | 2045 | $1.4 x 10^6$ | $8.1 x 10^5$ | $3.0 x 10^5$ | -0.67 | Acceptable
Recovery |
| | | | 2045/1 | $1.3 x 10^6$ | $9.0 x 10^5$ | $3.4 x 10^5$ | -0.58 | Acceptable
Recovery |
| | | | 2045/2 | $1.5 x 10^6$ | $8.8 x 10^5$ | $4.2 x 10^5$ | -0.55 | Acceptable
Recovery |
| Bacillus cereus
ATCC 10876 | diluted
1:10 | MSwab | 2045 | $1.5 x 10^5$ | $6.9 x 10^4$ | $1.6 x 10^4$ | -0.97 | Acceptable
Recovery |
| | | | 2045/1 | $1.6 x 10^5$ | $7.6 x 10^4$ | $1.8 x 10^4$ | -0.95 | Acceptable
Recovery |
| | | | 2045/2 | $1.6 x 10^5$ | $8.3 x 10^4$ | $1.4 x 10^4$ | -1.06 | Acceptable
Recovery |
| Staphylococcus aureus
(MRSA)
ATCC 43300 | diluted
1:10 | MSwab | 2045 | $2.1 x 10^6$ | $1.2 x 10^6$ | $8.0 x 10^5$ | -0.42 | Acceptable
Recovery |
| | | | 2045/1 | $1.9 x 10^6$ | $1.3 x 10^6$ | $8.9 x 10^5$ | -0.33 | Acceptable
Recovery |
| | | | 2045/2 | $1.9 x 10^6$ | $1.4 x 10^6$ | $9.4 x 10^5$ | -0.30 | Acceptable
Recovery |
| Staphylococcus aureus
ATCC 6538 | diluted
1:10 | MSwab | 2045 | $1.5 x 10^6$ | $9.2 x 10^5$ | $6.9 x 10^5$ | -0.34 | Acceptable
Recovery |
| | | | 2045/1 | $1.6 x 10^6$ | $1.0 x 10^6$ | $8.3 x 10^5$ | -0.29 | Acceptable
Recovery |
| | | | 2045/2 | $1.7 x 10^6$ | $1.3 x 10^6$ | $9.5 x 10^5$ | -0.25 | Acceptable
Recovery |
| Staphylococcus aureus
(MRSA)
ATCC 700698 | diluted
1:10 | MSwab | 2045 | $2.0 x 10^6$ | $1.6 x 10^6$ | $1.4 x 10^6$ | -0.15 | Acceptable
Recovery |
| | | | 2045/1 | $2.1 x 10^6$ | $1.6 x 10^6$ | $1.4 x 10^6$ | -0.18 | Acceptable
Recovery |
| | | | 2045/2 | $1.9 x 10^6$ | $1.5 x 10^6$ | $9.5 x 10^5$ | -0.30 | Acceptable
Recovery |
| Organism | Dilution:
0.5 McFarland bacterial
suspension with saline | Product | Lot Number | Average of CFUs recovered at time 0 hrs | Average of CFUs recovered at time 24 hrs | Average of CFUs recovered at time 48 hrs | Log10 decline | Interpretation |
| Streptococcus
pyogenes
ATCC 19615 | diluted
1:10 | MSwab | 2045 | $3.9 \times 10^5$ | $2.2 \times 10^5$ | $1.5 \times 10^5$ | -0.41 | Acceptable
Recovery |
| | | | 2045/1 | $4.8 \times 10^5$ | $2.1 \times 10^5$ | $1.5 \times 10^5$ | -0.51 | Acceptable
Recovery |
| | | | 2045/2 | $4.2 \times 10^5$ | $2.0 \times 10^5$ | $1.7 \times 10^5$ | -0.39 | Acceptable
Recovery |
| Streptococcus
pneumoniae
ATCC 6305 | diluted
1:10 | MSwab | 2045 | $1.2 \times 10^5$ | $1.0 \times 10^4$ | $9.4 \times 10^2$ | -2.11 | Acceptable
Recovery |
| | | | 2045/1 | $1.2 \times 10^5$ | $1.2 \times 10^4$ | $1.1 \times 10^3$ | -2.04 | Acceptable
Recovery |
| | | | 2045/2 | $1.2 \times 10^5$ | $1.2 \times 10^4$ | $1.1 \times 10^3$ | -2.04 | Acceptable
Recovery |
| Streptococcus
pneumoniae
ATCC 49136 | diluted
1:10 | MSwab | 2045 | $2.0 \times 10^5$ | $1.5 \times 10^4$ | $1.6 \times 10^3$ | -2.10 | Acceptable
Recovery |
| | | | 2045/1 | $1.8 \times 10^5$ | $1.5 \times 10^4$ | $1.1 \times 10^3$ | -2.21 | Acceptable
Recovery |
| | | | 2045/2 | $1.9 \times 10^5$ | $1.7 \times 10^4$ | $1.4 \times 10^3$ | -2.13 | Acceptable
Recovery |
| Enterococcus faecalis
ATCC 29212 | diluted
1:10 | MSwab | 2045 | $1.1 \times 10^6$ | $1.1 \times 10^6$ | $7.7 \times 10^5$ | -0.15 | Acceptable
Recovery |
| | | | 2045/1 | $1.1 \times 10^6$ | $9.6 \times 10^5$ | $8.1 \times 10^5$ | -0.13 | Acceptable
Recovery |
| | | | 2045/2 | $1.1 \times 10^6$ | $9.3 \times 10^5$ | $8.6 \times 10^5$ | -0.11 | Acceptable
Recovery |
| Staphylococcus
epidermidis
ATCC 12228 | diluted
1:10 | MSwab | 2045 | $1.6 \times 10^6$ | $1.1 \times 10^6$ | $5.2 \times 10^5$ | -0.49 | Acceptable
Recovery |
| | | | 2045/1 | $1.7 \times 10^6$ | $1.1 \times 10^6$ | $6.8 \times 10^5$ | -0.40 | Acceptable
Recovery |
| | | | 2045/2 | $1.4 \times 10^6$ | $9.0 \times 10^5$ | $5.5 \times 10^5$ | -0.41 | Acceptable
Recovery |
| Staphylococcus aureus
ATCC 29213 | diluted
1:10 | MSwab | 2045 | $1.3 \times 10^6$ | $8.7 \times 10^5$ | $5.2 \times 10^5$ | -0.40 | Acceptable
Recovery |
| | | | 2045/1 | $1.0 \times 10^6$ | $8.7 \times 10^5$ | $5.8 \times 10^5$ | -0.24 | Acceptable
Recovery |
| | | | 2045/2 | $1.0 \times 10^6$ | $9.9 \times 10^5$ | $6.0 \times 10^5$ | -0.22 | Acceptable
Recovery |
| Streptococcus agalactiae
ATCC 13813 | diluted
1:10 | MSwab | 2045 | $2.1 \times 10^6$ | $1.5 \times 10^6$ | $1.3 \times 10^6$ | -0.21 | Acceptable
Recovery |
| | | | 2045/1 | $1.9 \times 10^6$ | $1.7 \times 10^6$ | $1.3 \times 10^6$ | -0.16 | Acceptable
Recovery |
| | | | 2045/2 | $2.2 \times 10^6$ | $1.4 \times 10^6$ | $1.0 \times 10^6$ | -0.34 | Acceptable
Recovery |
| Kocuria rhizophila
ATCC 9341 | diluted
1:10 | MSwab | 2045 | $2.0 \times 10^5$ | $1.1 \times 10^5$ | $6.0 \times 10^4$ | -0.52 | Acceptable
Recovery |
| | | | 2045/1 | $2.1 \times 10^5$ | $1.5 \times 10^5$ | $5.4 \times 10^4$ | -0.59 | Acceptable
Recovery |
| | | | 2045/2 | $2.2 \times 10^5$ | $1.3 \times 10^5$ | $6.5 \times 10^4$ | -0.53 | Acceptable
Recovery |
| Listeria monocytogenes
ATCC 19114 | diluted
1:10 | MSwab | 2045 | $1.4 \times 10^6$ | $3.8 \times 10^5$ | $2.0 \times 10^5$ | -0.84 | Acceptable
Recovery |
| | | | 2045/1 | $1.3 \times 10^6$ | $5.3 \times 10^5$ | $1.8 \times 10^5$ | -0.86 | Acceptable
Recovery |
| | | | 2045/2 | $1.5 \times 10^6$ | $5.3 \times 10^5$ | $1.7 \times 10^5$ | -0.94 | Acceptable
Recovery |
| Bacillus cereus
ATCC 10876 | diluted
1:10 | MSwab | 2045 | $1.5 \times 10^5$ | $5.8 \times 10^4$ | $2.0 \times 10^3$ | -1.87 | Acceptable
Recovery |
| | | | 2045/1 | $1.6 \times 10^5$ | $7.8 \times 10^4$ | $2.1 \times 10^3$ | -1.88 | Acceptable
Recovery |
| | | | 2045/2 | $1.6 \times 10^5$ | $8.1 \times 10^4$ | $3.8 \times 10^3$ | -1.62 | Acceptable
Recovery |
| Staphylococcus aureus
(MRSA)
ATCC 43300 | diluted
1:10 | MSwab | 2045 | $2.1 \times 10^6$ | $1.0 \times 10^6$ | $5.0 \times 10^5$ | -0.62 | Acceptable
Recovery |
| | | | 2045/1 | $1.9 \times 10^6$ | $1.4 \times 10^6$ | $4.2 \times 10^5$ | -0.65 | Acceptable
Recovery |
| | | | 2045/2 | $1.9 \times 10^6$ | $9.1 \times 10^5$ | $4.3 \times 10^5$ | -0.65 | Acceptable
Recovery |
| Staphylococcus aureus
ATCC 6538 | diluted
1:10 | MSwab | 2045 | $1.5 \times 10^6$ | $7.6 \times 10^5$ | $5.1 \times 10^5$ | -0.47 | Acceptable
Recovery |
| | | | 2045/1 | $1.6 \times 10^6$ | $1.1 \times 10^6$ | $6.4 \times 10^5$ | -0.40 | Acceptable
Recovery |
| | | | 2045/2 | $1.7 \times 10^6$ | $1.0 \times 10^6$ | $7.9 \times 10^5$ | -0.33 | Acceptable
Recovery |
| Staphylococcus aureus
(MRSA)
ATCC 700698 | diluted
1:10 | MSwab | 2045 | $2.0 \times 10^6$ | $1.6 \times 10^6$ | $1.1 \times 10^6$ | -0.26 | Acceptable
Recovery |
| | | | 2045/1 | $2.1 \times 10^6$ | $1.5 \times 10^6$ | $1.3 \times 10^6$ | -0.21 | Acceptable
Recovery |
| | | | 2045/2 | $1.9 \times 10^6$ | $1.4 \times 10^6$ | $8.2 \times 10^5$ | -0.36 | Acceptable
Recovery |
| Organism | Dilution:
0.5 McFarland bacterial
suspension with saline | Product | Lot Number | Average of CFUs
recovered at time
0 hrs | Average of CFUs
recovered at time
24 hrs | Average of CFUs
recovered at time
48 hrs | Interpretation | |
| Streptococcus
pyogenes
ATCC 19615 | diluted
$10^{-3}$ | MSwab | 2045 | 283.3 | 172.3 | 153.0 | Acceptable
Recovery | |
| | | | 2045/1 | 266.7 | 220.0 | 169.0 | Acceptable
Recovery | |
| | | | 2045/2 | 275.7 | 240.7 | 160.3 | Acceptable
Recovery | |
| Streptococcus
pneumoniae
ATCC 6305 | diluted
$10^{-1.5}$ | MSwab | 2045 | 227.3 | 153.0 | 111.7 | Acceptable
Recovery | |
| | | | 2045/1 | 215.7 | 171.0 | 109.0 | Acceptable
Recovery | |
| | | | 2045/2 | 217.3 | 159.0 | 104.3 | Acceptable
Recovery | |
| Streptococcus
pneumoniae
ATCC 49136 | diluted
$10^{-1.5}$ | MSwab | 2045 | 279.7 | 206.3 | 123.7 | Acceptable
Recovery | |
| | | | 2045/1 | 256.7 | 207.7 | 113.0 | Acceptable
Recovery | |
| | | | 2045/2 | 270.0 | 195.7 | 123.0 | Acceptable
Recovery | |
| Enterococcus faecalis
ATCC 29212 | diluted
$10^{-3.5}$ | MSwab | 2045 | 207.3 | 172.3 | 158.3 | Acceptable
Recovery | |
| | | | 2045/1 | 214.0 | 167.7 | 158.3 | Acceptable
Recovery | |
| | | | 2045/2 | 223.3 | 183.3 | 140.0 | Acceptable
Recovery | |
| Staphylococcus
epidermidis
ATCC 12228 | diluted
$10^{-3.5}$ | MSwab | 2045 | 280.7 | 238.7 | 123.0 | Acceptable
Recovery | |
| | | | 2045/1 | 277.0 | 238.0 | 113.0 | Acceptable
Recovery | |
| | | | 2045/2 | 273.3 | 151.3 | 117.0 | Acceptable
Recovery | |
| Staphylococcus aureus
ATCC 29213 | diluted
$10^{-3.5}$ | MSwab | 2045 | 252.7 | 209.3 | 179.0 | Acceptable
Recovery | |
| | | | 2045/1 | 212.7 | 188.3 | 160.0 | Acceptable
Recovery | |
| | | | 2045/2 | 217.0 | 188.7 | 157.3 | Acceptable
Recovery | |
| Streptococcus agalactiae
ATCC 13813 | diluted
$10^{-3}$ | MSwab | 2045 | 174.0 | 121.0 | 117.7 | Acceptable
Recovery | |
| | | | 2045/1 | 162.3 | 127.0 | 100.3 | Acceptable
Recovery | |
| | | | 2045/2 | 186.0 | 148.3 | 124.7 | Acceptable
Recovery | |
| Kocuria rhizophila
ATCC 9341 | diluted
$10^{-2}$ | MSwab | 2045 | 271.7 | 237.0 | 212.0 | Acceptable
Recovery | |
| | | | 2045/1 | 267.7 | 223.3 | 202.0 | Acceptable
Recovery | |
| | | | 2045/2 | 269.3 | 235.0 | 179.0 | Acceptable
Recovery | |
| Listeria monocytogenes
ATCC 19114 | diluted
$10^{-3}$ | MSwab | 2045 | 267.3 | 243.3 | 209.7 | Acceptable
Recovery | |
| | | | 2045/1 | 275.0 | 242.0 | 192.7 | Acceptable
Recovery | |
| | | | 2045/2 | 274.3 | 226.7 | 198.3 | Acceptable
Recovery | |
| Bacillus cereus
ATCC 10876 | diluted
$10^{-1.5}$ | MSwab | 2045 | 234.7 | 185.3 | 167.0 | Acceptable
Recovery | |
| | | | 2045/1 | 246.0 | 182.7 | 151.7 | Acceptable
Recovery | |
| | | | 2045/2 | 231.0 | 179.0 | 144.7 | Acceptable
Recovery | |
| Staphylococcus aureus
(MRSA)
ATCC 43300 | diluted
$10^{-3.5}$ | MSwab | 2045 | 204.7 | 185.0 | 172.7 | Acceptable
Recovery | |
| | | | 2045/1 | 211.7 | 185.7 | 177.3 | Acceptable
Recovery | |
| | | | 2045/2 | 196.7 | 183.7 | 161.0 | Acceptable
Recovery | |
| Staphylococcus aureus
ATCC 6538 | diluted
$10^{-3.5}$ | MSwab | 2045 | 149.0 | 123.0 | 98.7 | Acceptable
Recovery | |
| | | | 2045/1 | 172.0 | 138.0 | 108.3 | Acceptable
Recovery | |
| | | | 2045/2 | 167.3 | 142.3 | 98.3 | Acceptable
Recovery | |
| Staphylococcus aureus
(MRSA)
ATCC 700698 | diluted
$10^{-3.5}$ | MSwab | 2045 | 257.0 | 223.3 | 204.0 | Acceptable
Recovery | |
| | | | 2045/1 | 254.3 | 229.0 | 203.3 | Acceptable
Recovery | |
| | | | 2045/2 | 257.7 | 238.0 | 202.7 | Acceptable
Recovery | |
| Organism | Dilution:
0.5 McFarland bacterial
suspension with saline | Product | Lot Number | Average of CFUs recovered at time 0 hrs | Average of CFUs recovered at time 24 hrs | Average of CFUs recovered at time 48 hrs | Interpretation | |
| Streptococcus pyogenes
ATCC 19615 | diluted
$10^{-3}$ | MSwab | 2045 | 283.3 | 184.0 | 113.3 | Acceptable
Recovery | |
| | | | 2045/1 | 266.7 | 196.0 | 123.0 | Acceptable
Recovery | |
| | | | 2045/2 | 275.7 | 211.0 | 130.0 | Acceptable
Recovery | |
| Streptococcus pneumoniae
ATCC 6305 | diluted
$10^{-1.5}$ | MSwab | 2045 | 227.3 | 131.7 | 83.0 | Acceptable
Recovery | |
| | | | 2045/1 | 215.7 | 149.3 | 73.0 | Acceptable
Recovery | |
| | | | 2045/2 | 217.3 | 137.3 | 80.0 | Acceptable
Recovery | |
| Streptococcus pneumoniae
ATCC 49136 | diluted
$10^{-1.5}$ | MSwab | 2045 | 279.7 | 148.3 | 71.0 | Acceptable
Recovery | |
| | | | 2045/1 | 256.7 | 171.0 | 81.7 | Acceptable
Recovery | |
| | | | 2045/2 | 270.0 | 171.0 | 71.0 | Acceptable
Recovery | |
| Enterococcus faecalis
ATCC 29212 | diluted
$10^{-3.5}$ | MSwab | 2045 | 207.3 | 140.0 | 117.7 | Acceptable
Recovery | |
| | | | 2045/1 | 214.0 | 140.0 | 117.7 | Acceptable
Recovery | |
| | | | 2045/2 | 223.3 | 134.0 | 96.0 | Acceptable
Recovery | |
| Staphylococcus epidermidis
ATCC 12228 | diluted
$10^{-3.5}$ | MSwab | 2045 | 280.7 | 147.0 | 89.7 | Acceptable
Recovery | |
| | | | 2045/1 | 277.0 | 154.0 | 93.3 | Acceptable
Recovery | |
| | | | 2045/2 | 273.3 | 167.7 | 88.0 | Acceptable
Recovery | |
| Staphylococcus aureus
ATCC 29213 | diluted
$10^{-3.5}$ | MSwab | 2045 | 252.7 | 176.7 | 112.0 | Acceptable
Recovery | |
| | | | 2045/1 | 212.7 | 178.3 | 126.7 | Acceptable
Recovery | |
| | | | 2045/2 | 217.0 | 131.7 | 107.3 | Acceptable
Recovery | |
| Streptococcus agalactiae
ATCC 13813 | diluted
$10^{-3}$ | MSwab | 2045 | 174.0 | 112.7 | 80.3 | Acceptable
Recovery | |
| | | | 2045/1 | 162.3 | 119.7 | 88.0 | Acceptable
Recovery | |
| | | | 2045/2 | 186.0 | 112.7 | 84.0 | Acceptable
Recovery | |
| Kocuria rhizophila
ATCC 9341 | diluted
$10^{-2}$ | MSwab | 2045 | 271.7 | 198.3 | 165.3 | Acceptable
Recovery | |
| | | | 2045/1 | 267.7 | 196.3 | 145.7 | Acceptable
Recovery | |
| | | | 2045/2 | 269.3 | 204.7 | 142.3 | Acceptable
Recovery | |
| Listeria monocytogenes
ATCC 19114 | diluted
$10^{-3}$ | MSwab | 2045 | 267.3 | 221.3 | 167.0 | Acceptable
Recovery | |
| | | | 2045/1 | 275.0 | 221.0 | 162.0 | Acceptable
Recovery | |
| | | | 2045/2 | 274.3 | 211.3 | 172.0 | Acceptable
Recovery | |
| Bacillus cereus
ATCC 10876 | diluted
$10^{-1.5}$ | MSwab | 2045 | 234.7 | 156.0 | 116.0 | Acceptable
Recovery | |
| | | | 2045/1 | 246.0 | 167.0 | 120.3 | Acceptable
Recovery | |
| | | | 2045/2 | 231.0 | 161.7 | 117.3 | Acceptable
Recovery | |
| Staphylococcus aureus
(MRSA)
ATCC 43300 | diluted
$10^{-3.5}$ | MSwab | 2045 | 204.7 | 173.7 | 153.0 | Acceptable
Recovery | |
| | | | 2045/1 | 211.7 | 174.3 | 142.3 | Acceptable
Recovery | |
| | | | 2045/2 | 196.7 | 174.3 | 137.3 | Acceptable
Recovery | |
| Staphylococcus aureus
ATCC 6538 | diluted
$10^{-3.5}$ | MSwab | 2045 | 149.0 | 117.0 | 72.7 | Acceptable
Recovery | |
| | | | 2045/1 | 172.0 | 113.3 | 82.0 | Acceptable
Recovery | |
| | | | 2045/2 | 167.3 | 133.3 | 86.3 | Acceptable
Recovery | |
| Staphylococcus aureus
(MRSA)
ATCC 700698 | diluted
$10^{-3.5}$ | MSwab | 2045 | 257.0 | 205.0 | 171.7 | Acceptable
Recovery | |
| | | | 2045/1 | 254.3 | 203.0 | 176.3 | Acceptable
Recovery | |
| | | | 2045/2 | 257.7 | 205.3 | 170.3 | Acceptable
Recovery | |
·
·
· ·
・
:
6
TABLE 2. SUMMARY OF RESULTS FOR BACTERIAL RECOVERY STUDIES
SWAB ELUTION METHOD, 20-25°C
,
.
:
:
•
'
·
.
·
.
'
7
.
:
:
.
,
7
TABLE 3. SUMMARY OF RESULTS FOR BACTERIAL RECOVERY STUDIES
:
·
・
·
:
.
:
.
:
:
:
:
・
8
:
.
.
:
.
.
8
TABLE 4. SUMMARY OF RESULTS FOR BACTERIAL RECOVERY STUDIES
.
.
・
·
:
9
TABLE S. SUMMARY OF RESULTS FOR VIRAL RECOVERY STUDIE
| Organism | Dilution | Product | Lot Number | Average of foci of infected cells at time 0 hrs | Average of foci of infected cells at time 24 hrs | Average of foci of infected cells at time 48 hrs | Log₁₀ decline | Interpretation |
|---|---|---|---|---|---|---|---|---|
| HSV 1 | ||||||||
| ATCC VR539 | diluted | |||||||
| 10⁻² | MSwab | 2045 | 535.3 | 302.6 | 175.6 | -0.48 | Acceptable | |
| Recovery | ||||||||
| HSV 1 | ||||||||
| ATCC VR539 | diluted | |||||||
| 10⁻² | MSwab | 2045/ 1 | 505.7 | 354.7 | 195.0 | -0.41 | Acceptable | |
| Recovery | ||||||||
| HSV 1 | ||||||||
| ATCC VR539 | diluted | |||||||
| 10⁻² | MSwab | 2045/ 2 | 501.7 | 369.3 | 213.7 | -0.37 | Acceptable | |
| Recovery | ||||||||
| HSV 2 | ||||||||
| ATCC VR734 | diluted | |||||||
| 10⁻¹ | MSwab | 2045 | 902.0 | 526.0 | 209.7 | -0.63 | Acceptable | |
| Recovery | ||||||||
| HSV 2 | ||||||||
| ATCC VR734 | diluted | |||||||
| 10⁻¹ | MSwab | 2045/ 1 | 889.7 | 419.0 | 245.7 | -0.56 | Acceptable | |
| Recovery | ||||||||
| HSV 2 | ||||||||
| ATCC VR734 | diluted | |||||||
| 10⁻¹ | MSwab | 2045/ 2 | 954.0 | 486.0 | 275.7 | -0.54 | Acceptable | |
| Recovery |
TARLE 6. SUMMARY OF RESULTS FOR VIRAL RECOVERY STILDIES
| Organism | Dilution | Product | Lot Number | Average of foci of
infected cells at
time
0 hrs | Average of foci of
infected calls at
time
24 hrs | Average of foci of
infected cells at
time
48 hrs | Logi, decline | Interpretation |
|----------------------------------------|----------|---------|------------|----------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|------------------------|----------------|
| HSV 1
diluted
ATCC VR539
10-5 | | 2045 | 535.3 | 199.3 | 142.6 | -0.57 | Acceptable
Recovery | |
| | MSwab | 2045/ 1 | 505.7 | 195.7 | . 140.7 | ન્વ સ્ક્ર | Acceptable
Recovery | |
| | | 2045/ 2 | 501.7 | 152.0 | 103.3 | -0.69 | Acceptable
Recovery | |
| HSV 2
diluted
ATCC VR734
10 | MSwab | 2045 | 902.0 | 387.7 | 184.7 | -0.69 | Acceptable
Recovery | |
| | | 2045/ 1 | 889.7 | 414.7 | 203,7 | -0.64 | Acceptable
Recovery | |
| | | | 954.0 | 375.3 | 187.0 | -0.71 | Acceptable
Recovery | |
Recovery Stability: Recovery studies were performed using aged MSwab System devices at specified time intervals up to 13 months following the date of manufacture. The bacteria and viruses selected for the stability testing were:
| Streptococcus pyogenes | ATCC 19615 |
|---|---|
| Streptococcus pneumoniae | ATCC 6305 |
| Staphylococcus aureus (Methicillin resistant) | ATCC 43300 |
| Herpes Simplex Virus Type 1 (HSV 1) | ATCC VR-539 |
| Herpes Simplex Virus Type 2 (HSV 2) | ATCC VR-734 |
The recovery stability studies were performed at two different temperature ranges, 4-8°C and 20-25°C. Viability performance was determined for each test organism at the 48 hours time point compared to the 0 hour time point. The results from three representative lots demonstrated the ability of the MSwab System to maintain the viability of the bacterial and viral strains evaluated for at least 13 months following the date of manufacture.
10
pH Stability: The pH of MSwab medium was measured at specified time intervals up to 13 months following the date of manufacture. The results from three representative lots demonstrated the ability to maintain pH within the target range at all time intervals tested.
Sterilization: Copan MSwab tubes and caps are treated by gamma irradiation in accordance with UNI EN ISO 11137:2006, "Sterilization of health care products - Radiation." The tubes are filled with MSwab liquid medium aseptically under controlled conditions. Representative samples were tested to validate the medium filling process with respect to risk of microbial contamination.
The nylon flocked specimen collection swabs provided with the MSwab collection kits are individually wrapped inside a peel pouch and sterilized by ETO treatment in accordance with UNI EN ISO 11135:2007, "Sterilization of health care products - Ethylene oxide."
Biocompatibility: The nylon flocked swab component of the MSwab System was tested in accordance with ISO 10993, "Biological Evaluation of Medical Devices." The results demonstrated that the swab component is non-cytotoxic, non-irritating and non-sensitizing.
Cytotoxicity: Testing was performed to evaluate the cytotoxicity of the MSwab System using an MRC5 cell line. The results from three representative lots aged 1 month, 7 months and 13 months showed no alteration of the cell monolayers compared to the negative control.
9. CONCLUSIONS DRAWN FROM NON-CLINICAL TESTS
The non-clinical testing conducted to evaluate the Copan MSwab Collection, Transport and Preservation System demonstrated the successful performance of the device for its intended use and the substantial equivalence of the MSwab System to the cited predicate devices.
11
All study protocols, reports, data, and criteria were reviewed and found acceptable. The device was found to demonstrate expected performance, comparable to the predicate devices (k 061301) and (k 042970)
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Reviewer Signature: Jason Heflyer Date: 05.24.2012
Management Concurrence: Saguntar Date: 5-25-12
Management Concurrence:
PILOT TRIAGE PROGRAM: OIVD, 4/11/12, v1.1
12
Appendix B
Statement for the Record, K 121039
This 510(k) was reviewed under OIVD's Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.
The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant's 510(k) summary for a summary of the information that supports this SE determination.
OIVD, 4/2/12, v1.1
.
.
.
.
.
13
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
COPAN Flock Technologies c/o Cynthia Sinclair, RAC Aptiv Soutions 49 Plain Street North Attleboro, MA 02760
MAY 2 5 2012
Re: K121039
Trade/Device Name: Copan MSwab Collection, Transport and Preservation System Regulation Number: 21 CFR 866.2900
Regulation Name: Microbiological specimen collection and transport devices Regulatory Class: Class I
Product Code: JTW Dated: April 3, 2012 Received: April 5, 2012
Dear Ms. Sinclair:
We have reviewed your Section 510(k) premarket notification of intent to market the device i 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket which in the FDA finding of substantial equivalence of your device to a legally marketed
14
Page 2 - Cynthia Sinclair, RAC
predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Saggitgus.
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
15
Indications for Use
510(k) Number (if known): K12