TRANSPORT CULTURE MEDIUM DEVICE

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K113249 B. Purpose for Submission: New device C. Measurand: Not applicable (N/A). D. Type of Test: Transport culture medium device E. Applicant: Puritan Medical Products LLC F. Proprietary and Established Names: Puritan UTM-RT Collection and Transport System ## G. Regulatory Information: 1. Regulation section: 21 CFR 866.2390, Transport culture medium 2. Product code(s): JSM; Culture media, non-propagating transport LIO; Device, specimen collection 3. Classification: Class: I 4. Panel: 83 Microbiology ## H. Intended Use: Puritan UTM – RT Collection and Transport System is intended for the collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the testing laboratory. The specimen transported in the Puritan UTM - RT can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture. ### 2. Indication(s) for use: Puritan UTM – RT Collection and Transport System is intended for the collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the collection site to the testing laboratory. The specimen transported in the Puritan UTM - RT can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture. ### 3. Special conditions for use statement(s): For prescription use {1} 4. Special instrument requirements: None I. Device Description: Each tube of Puritan UTM – RT consists of modified Hank’s balanced salt solution, gelatin and bovine serum albumin as stabilizers, sucrose, glutamic acid and (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid) (HEPES). The presence of buffered salts in the medium protects pathogens that are sensitive to pH changes. Gelatin and bovine serum albumin are source of nutrition to support viability of fastidious bacteria during storage and transport. Sucrose aids in the preservation of viruses and chlamydiae when specimens are frozen for prolonged storage. Antimicrobial agents are incorporated to minimize commensal bacterial and fungal contamination. Phenol red is added to act as a pH indicator. Puritan UTM-RT is comprised of a conical polypropylene vial filled with three 3-mm glass beads and 1.5ml or 3 mL of the transport medium, affixed with a high density polyethylene cap. Each unit of Puritan UTM-RT is provided in a peel pouch containing one of the following swab combinations: - 1ml UTM with ultrafine tip HydraFlock® Swab - 3ml UTM with one elongated tip HydraFlock® and one ultrafine tip swab - 3ml UTM with elongated tip HydraFlock® swab - 3ml UTM with mini-tip HydraFlock® swab, scored shaft - 3ml UTM with ultrafine HydraFlock® tip swab - 3ml UTM vial with 2 regular polyester tip swabs, scored shaft - 3ml UTM vial with regular polyester tip and one wire/plastic shaft with polyester tip J. Substantial Equivalence Information: 1. Predicate device name(s): Copan (BD) UTM-RT System 2. Predicate 510(k) number(s): K042970 1. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Intended Use | Puritan UTM – RT is intended for the collection and transport of clinical samples containing viruses, chlamydiae, mycoplasmas and ureaplasmas from the | BD™ Universal Viral Transport System is intended for the collection and transport of clinical specimens containing viruses, chlamydiae, mycoplasmas and ureaplasmas | {2} 3 | | collection site to the testing laboratory. The specimen transported in the Puritan UTM - RT can be used in the laboratory to perform viral, chlamydial, mycoplasmal and ureaplasmal culture. | from the collection site to the testing laboratory. This system can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasmal, and ureaplasmal culture. | | --- | --- | --- | | Medium | Hank’s balanced salt solution with additives | Same | | Product Configuration | Medium in vial with cap | Same | | | System including Medium and swab in peel pouch option | Same | | Differences | | | | Item | Device | Predicate | | Swab Tip | HydraFlock® Swab (Polyester) | Nylon Flock Swab | K. Standard/Guidance Document Referenced (if applicable): 1. Quality Control of Microbiological Transport Systems M40-A, Clinical Laboratory and Standards Institute (CLSI), Wayne, PA, 2003. [The standard was mentioned for informational purpose only. No claims were made] L. Test Principle: Not applicable M. Performance Characteristics (if/when applicable): 1. Analytical performance: Recovery studies: The following viruses were chosen for recovery study: Adenovirus Echovirus Type 30 Herpes Simplex Virus Type II Parainfluenza Type 3 Cytomegalovirus Herpes Simplex Virus Type I Influenza A Respiratory Syncytial Virus {3} 4 # Varicella Zoster Virus Among bacteria, *Chlamydia pneumoniae*, *Chlamydia trachomatis*, *Mycoplasma pneumoniae*, *Mycoplasma hominis*, and *Ureaplasma urealyticum* were used for testing. The survival and recovery of viruses, chlamydiae, mycoplasmas and ureaplasmas was tested to determine the performance characteristics of Puritan Universal Transport Medium (UTM-RT). Neat stocks of the above microorganisms were prepared for testing. Two different dilutions of the neat stock suspensions were prepared and, from these, 100 $\mu$l were directly inoculated onto swabs in triplicate. The swabs were transferred into the transport medium and held at both $4^{\circ}\mathrm{C}$ and room temperature $(20 - 25^{\circ}\mathrm{C})$ for the required amount of time. At key time points following inoculation (0, 24, and $48\mathrm{h}$ ), each sample was vortexed after which an aliquot of the suspension was inoculated into shell vials or suitable culture media. Viability of viruses and chlamydiae was determined by shell vial assay followed by immunostaining and enumeration of fluorescent foci. The viability of mycoplasmas and ureaplasmas was determined using direct culture methods onto appropriate growth media followed by enumeration of colony forming units (CFU). Cultures were processed by standard laboratory techniques and examined following optimal incubation periods. The results of the study are presented in Tables 1-3. The results demonstrate the ability of Puritan Medical Products UTM-RT to sustain the viability and recovery of test bacteria and viruses for at least $48\mathrm{h}$ at $4^{\circ}\mathrm{C}$ and room temperature $(20 - 25^{\circ}\mathrm{C})$ . Viability of microorganisms in the Puritan UTM - RT transport system other than the ones listed above was not tested and is not known. It should be validated by the user. {4} Table 1- Recovery of Viruses | Organism | Dilution of Neat Stocka | Percent Infectivity of Host Cells | Storage Time | Incubation Time Prior to Reading | Mean Viability of Test Organism Using Test (Puritan) Device: Foci Countsb with SD | | | --- | --- | --- | --- | --- | --- | --- | | | | (% Infectivity) | (Hours) | (Hours) | 4°C | RT | | Adenovirus | 1:100 | 2% | 0 | | 343 ± 72 | 343 ± 72 | | | | | 24 | 24 | 550 ± 77 | 434 ± 66 | | | | | 48 | | 652 ± 143 | 408 ± 89 | | | 1:500 | 3% | 0 | | 118 ± 78 | 118 ± 78 | | | | | 24 | 24 | 192 ± 37 | 161 ± 28 | | | | | 48 | | 145 ± 57 | 47 ± 17 | | Cytomegalovirus | 1:10 | 100% | 0 | | 751 ± 71 | 751 ± 71 | | | | | 24 | 24 | 209 ± 26 | 47 ± 3 | | | | | 48 | | 269 ± 58 | 319 ± 34 | | | 1:100 | 100% | 0 | | 242 ±7 | 242 ± 7 | | | | | 24 | 24 | 134 ± 13 | 47 ± 5 | | | | | 48 | | 86 ± 35 | 207 ± 110 | | Echovirus Type 30 | 1:100 | 64% | 0 | | 95 ± 52 | 95 ± 52 | | | | | 24 | 24 | 337 ± 178 | 332 ± 221 | | | | | 48 | | 454 ± 210 | 605 ± 194 | | | 1:500 | 100% | 0 | | 63 ± 48 | 63 ± 48 | | | | | 24 | 24 | 194 ± 134 | 214 ± 108 | | | | | 48 | | 252 ± 31 | 151 ± 41 | | Herpes Simplex Type 1 | 1:10 | 6% | 0 | | 207 ± 78 | 207 ± 78 | | | | | 24 | 24 | 665 ± 189 | 325 ± 107 | | | | | 48 | | 609 ± 238 | 772 ± 243 | | | 1:100 | 48% | 0 | | 167 ± 101 | 167 ± 101 | | | | | 24 | 24 | 89 ± 38 | 72 ± 17 | | | | | 48 | | 96 ± 14 | 107 ± 35 | | Herpes Simplex Type 2 | 1:10 | 47% | 0 | | 126 ± 13 | 126 ± 13 | | | | | 24 | 24 | 51 ± 21 | 85 ± 25 | | | | | 48 | | 108 ± 32 | 6 ± 3 | | | 1:100 | 97% | 0 | | 26 ± 6 | 26 ± 6 | | | | | 24 | 24 | 25 ± 15 | 37 ± 13 | | | | | 48 | | 17 ± 6 | 8 ± 6 | {5} Table 1 Recovery of Viruses (continued) | Organism | Dilution of Neat Stocka | Percent Infectivity of Host Cells | Storage Time | Incubation Time Prior to Reading | Mean Viability of Test Organism Using Test (Puritan) Device: Foci Countsb with SD | | | --- | --- | --- | --- | --- | --- | --- | | | | (% Infectivity) | (Hours) | (Hours) | 4°C | RT | | Influenza A | 1:50 | 10% | 0 | 24 | 298 ± 86 | 289 ± 86 | | | | | 24 | | 470 ± 96 | 250 ± 89 | | | | | 48 | | 173 ± 95 | 93 ± 41 | | | 1:100 | 12% | 0 | 24 | 186 ± 130 | 186 ± 130 | | | | | 24 | | 109 ± 56 | 181 ± 117 | | | | | 48 | | 82 ± 36 | 30 ± 13 | | Parainfluenza A | 1:10 | 3% | 0 | 48 | 501 ± 116 | 501 ± 116 | | | | | 24 | | 30 ± 10 | 628 ± 208 | | | | | 48 | | 101 ± 26 | 107 ± 56 | | | 1:100 | 25% | 0 | 48 | 358 ± 87 | 358 ± 87 | | | | | 24 | | 24 ± 10 | 292 ± 60 | | | | | 48 | | 47 ± 13 | 54 ± 23 | | Respiratory Syncytial Virus | 1:10 | 76% | 0 | 24 | 140 ± 19 | 140 ± 19 | | | | | 24 | | 176 ± 20 | 170 ± 14 | | | | | 48 | | 78 ± 24 | 131 ± 26 | | | 1:100 | 100% | 0 | 24 | 25 ± 6 | 25 ± 6 | | | | | 24 | | 74 ± 15 | 62 ± 5 | | | | | 48 | | 59 ± 19 | 74 ± 4 | | Varicella-Zoster Virus | 1:10 | 100% | 0 | 24 | 325 ± 91 | 325 ± 91 | | | | | 24 | | 253 ± 51 | 212 ± 43 | | | | | 48 | | 33 ± 13 | 117 ± 47 | | | 1:100 | 100% | 0 | 24 | 132 ± 45 | 132 ± 45 | | | | | 24 | | 97 ± 12 | 97 ± 3 | | | | | 48 | | 87 ± 69 | 94 ± 49 | | aFrom each dilution, 100 μL were inoculated onto test swab tip followed by placement of the swab into the test device containing 3 mL of transport medium | | | | | | | | bAverage of triplicate tests (± standard deviation) performed on 200 μL of test device medium at each time point; RT, room temperature | | | | | | | {6} Table 2- Recovery of Chlamydia | Organism | Dilution of Neat Stocka | Percent Infectivity of Host Cells | Storage Time | Incubation Time Prior to Reading | Mean Viability of Test Organism Using Test (Puritan) Device: Foci Countsb with SD | | | --- | --- | --- | --- | --- | --- | --- | | | | (% Infectivity) | (Hours) | (Hours) | 4°C | RT | | Chlamydia pneumoniae | 1:10 | 100% | 0 | | 169 ± 33 | 169 ± 33 | | | | | 24 | 48 | 356 ± 70 | 456 ± 68 | | | | | 48 | | 301 ± 121 | 345 ± 66 | | | 1:100 | 100% | 0 | | 65 ± 6 | 65 ± 6 | | | | | 24 | 48 | 163 ± 25 | 134 ± 35 | | | | | 48 | | 110 ± 24 | 131 ± 33 | | Chlamydia trachomatis | 1:10 | 100% | 0 | | 227 ± 63 | 227 ± 63 | | | | | 24 | 48 | 204 ± 79 | 627 ± 197 | | | | | 48 | | 184 ± 62 | 234 ± 102 | | | 1:100 | 100% | 0 | | 73 ± 10 | 73 ± 10 | | | | | 24 | 48 | 60 ± 12 | 138 ± 50 | | | | | 48 | | 57 ± 19 | 92 ± 32 | | aFrom each dilution, 100 μL were inoculated onto test swab tip followed by placement of the swab into the test device containing 3 mL of transport mediumbAverage of triplicate tests (± standard deviation) performed on 200 μL of test device medium at each time point; RT, room temperature | | | | | | | Table 3- Recovery of Mycoplasma and Ureaplasma | Organism | Dilution of Neat Stocka | Storage Time | Incubation Time Prior to Reading | Mean Viability of Test Organism Using Test (Puritan) Device: CFU Countsb with SD | | | --- | --- | --- | --- | --- | --- | | | | (Hours) | (Days) | 4°C | RT | | Mycoplasma hominis | 1:500 | 0 | | TNTC | TNTC | | | | 24 | 3 | TNTC | 34 ± 5 | | | | 48 | | TNTC | 75 ± 11 | | | 1:1000 | 0 | | 171 ± 42 | 171 ± 42 | | | | 24 | 3 | 136 ± 9 | 28 ± 7 | | | | 48 | | 160 ± 19 | 9 ± 5 | | Mycoplasma | Neat | 0 | 6 | TNTC | TNTC | {7} | pneumoniae | | 24 | | TNTC | TNTC | | --- | --- | --- | --- | --- | --- | | | | 48 | | TNTC | 1116 ± 119 | | | 1:10 | 0 | | 887 ± 334 | 887 ± 334 | | | | 24 | 6 | 416 ± 177 | 275 ± 62 | | | | 48 | | 600 ± 303 | 144 ± 53 | | Ureaplasma urealyticum | 1:500 | 0 | | TNTC | TNTC | | | | 24 | 5 | TNTC | TNTC | | | | 48 | | TNTC | TNTC | | | 1:1000 | 0 | | 811 ± 311 | 811 ± 311 | | | | 24 | 5 | 893 ± 486 | 775 ± 306 | | | | 48 | | 611 ± 89 | 486 ± 134 | | aFrom each dilution, 100 μL were inoculated onto test swab tip followed by placement of the swab into the test device containing 3 mL of transport medium | | | | | | | bAverage of triplicate tests (± standard deviation) performed on 100 μL of test device medium at each time point; RT, room temperature; TNTC, too numerous to count, defined as 1,000 CFU for M. hominis and 2,000 CFU for M. pneumoniae and U. urealyticum | | | | | | a. Precision/Reproducibility: Not applicable b. Linearity/assay reportable range: Not applicable c. Traceability, Stability, Expected values (controls, calibrators, or methods): pH Stability: The pH of the test device was measured at predetermined time intervals up to 18 month after the manufacturing date. The test was performed using calibrated pH meter with random samples from three different lots of Puritan UTM-RT. All samples tested were found to maintain pH within the specified target range. Antibiotics Stability Test: Antibiotics stability of test device was evaluated using three expired lots and a new lot of test device and compared to the predicate device. All products tested demonstrated the ability to control bacterial activities up to 72 hours. Cytotoxicity: Cytotoxicity testing using an MRC-5 cell line in conjunction with a standard Sulforhodamine B assay demonstrated no cellular toxicity associated with three lots of test devices when statistically compared to negative controls. Sterilization: All plastic components of Puritan UTM-RT are validated and sterilized following ANSI/AAMI/ISO 11137:2006, Sterilization of health care products-Radiation or by ANSI/AAMI/ISO11135:2007, Sterilization of health care products-ethylene oxide. Puritan UTM-RT tubes are filled aseptically under {8} control conditions. Representative samples from each lot of Puritan UTM-RT are tested according to the USP 34 NF, 29:2011, <71>, Sterility Tests. d. Detection limit: Not applicable e. Analytical specificity: Not applicable f. Interfering Substances: Not applicable g. Assay cut-off: Not applicable 2. Comparison studies: a. Method comparison with predicate device: Method comparison is not applicable for a transport medium. The performance of the test device is compared to the predicate by analytical studies or bench testing concerning viral and bacterial recovery. Recovery comparison: For both transport systems, test viruses and bacteria were quantified during 48 hours at the two storage temperatures as described above for tables 1 to 3. Culture recovery data between the test and predicate devices were statistically analyzed and compared. One-way ANOVA demonstrated statistically significant differences (P<0.05) between the two devices under certain conditions. The differences were considered to be the result of normal microbiological variability and thus not significant from a clinical stand point. Qualitative and not quantitative results are most often the critical endpoint in the clinical diagnosis of an infectious agent. It is concluded that under the conditions of testing the test organisms could be recovered from the new device just as with the comparator thus making it a valid system for the collection, storage, and transport of clinical specimens. b. Matrix comparison: Not applicable 3. Clinical studies: a. Clinical Sensitivity: Not applicable b. Clinical specificity: Not applicable c. Other clinical supportive data (when a. and b. are not applicable): Not applicable {9} 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Not applicable N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 10