ARX Liquid Amies Collection & Transport System

{0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY ## I Background Information: A 510(k) Number K222613 B Applicant ARX Sciences, Inc. C Proprietary and Established Names ARX Liquid Amies Collection & Transport System D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | LIO, JTW, JTX | Class I, reserved | 21 CFR 866.2900 - Microbiological Specimen Collection And Transport Device | MI - Microbiology | ## II Submission/Device Overview: A Purpose for Submission: New Device B Measurand: Not Applicable C Type of Test: Specimen Collection and Transport System for Clinical Specimens from a patient to the laboratory for bacteriological testing. ## III Intended Use/Indications for Use: A Intended Use(s): See Indications for Use below. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov K222613 - Page 1 of 18 {1} B Indication(s) for Use: The ARX Liquid Amies Collection & Transport System (ARX) is intended for use in the collection of clinical specimens (i.e., nasal secretion/wash; lachrymal secretion/tears; auricular secretion/cerumen; urethral, rectal, or vaginal swab; wound/abscess material) potentially containing aerobic, anaerobic, and fastidious bacteria and their transport at 2–8°C or 25–30°C from the patient to the laboratory for bacteriological examination and culture. In the laboratory, the collected and transported clinical specimens of nasal, lachrymal, ceruminous, vaginal, urethral, rectal, and wound/abscess origin are processed using standard clinical laboratory operating procedures for bacterial culture. C Special Conditions for Use Statement(s): Rx – For Prescription Use Only D Special Instrument Requirements: Not Applicable IV Device/System Characteristics: A Device Description: The ARX Liquid Amies Collection & Transport System consists of a polypropylene screw-cap vial containing Liquid Amies transport medium and three (3) sterile peel-open pouches containing a pre-scored Microbrush nylon flocked swab for collecting specimens. The three (3) nylon flocked swabs are provided with various score points, tip sizes, and configuration to facilitate specimen collection from various sites on patients’ bodies. Nylon flocked swabs facilitate quick absorption and release of clinical specimens. Proper specimen collection from the patient is critical for successful isolation and identification of infectious organisms. Amies liquid medium is a non-nutritive balanced salt solution containing inorganic phosphates to provide buffering capability, sodium chloride, potassium chloride, calcium chloride, and magnesium chloride to provide essential ions that help maintain osmotic balance and control permeability of bacterial cells. It also contains sodium thioglycolate to provide a reduced environment. ARX Liquid Amies transport medium is capable of maintaining the viability of aerobic, anaerobic, and fastidious bacteria (such as Neisseria gonorrhoeae) during specimen transport to the laboratory for bacteriological testing and culture. All raw materials used in the manufacture of ARX Liquid Amies Collection & Transport System are qualified before use. Every batch of ARX Liquid Amies Collection & Transport System is tested prior to release for sterility, pH, and background count using microscopic examination. Representative samples of each batch are further evaluated for their ability to maintain the viability of selected bacterial agents over predefined time periods. B Principle of Operation: Once a specimen is collected with a swab and added to the ARX liquid Amies transport medium vial, it is immediately processed to achieve optimal recovery. For cases where immediate K222613 - Page 2 of 18 {2} processing (i.e., within 2 hours) is not possible, specimens are stored at 2–30°C and processed within 48 hours (except for Neisseria gonorrhoeae, which should be processed within 24 hours). V Substantial Equivalence Information: A Predicate Device Name(s): Puritan Liquid Amies Collection and Transport System B Predicate 510(k) Number(s): K120846 C Comparison with Predicate(s): | Device & Predicate Device(s): | Device: K222613 | Predicate: K120846 | | --- | --- | --- | | Device Trade Name | ARX Liquid Amies Collection & Transport System | Puritan Liquid Amies Collection and Transport System | | General Device Characteristic Similarities | | | | Intended Use/Indications For Use | The ARX Liquid Amies Collection & Transport System (ARX) is intended for use in the collection of clinical specimens (i.e., nasal secretion/wash; lachrymal secretion/tears; auricular secretion/cerumen; urethral, rectal, or vaginal swab; wound/abscess material) potentially containing aerobic, anaerobic, and fastidious bacteria and their transport at 2–8°C or 25–30°C from the patient to the laboratory for bacteriological examination and culture. In the laboratory, the collected and transported clinical specimens of nasal, lachrymal, ceruminous, vaginal, urethral, rectal, and wound/abscess origin are processed using standard clinical laboratory operating procedures for bacterial culture. | Puritan Liquid Amies Collection and Transport System is intended for use in the collection and transport of clinical specimens containing aerobic, anaerobic and fastidious bacteria from the patient to the laboratory for bacteriological examination and culture. | | Product Code | LIO, JTW, JTX | SAME | | Use/Reuse information | Single Use Device (SUD) | SAME | K222613 - Page 3 of 18 {3} K222613 - Page 4 of 18 | Device & Predicate Device(s): | Device: K222613 | Predicate: K120846 | | --- | --- | --- | | Product Configuration | Base Transport Medium in a screw-capped, conical-bottom tube; specimen collection swabs individually in sterile peel pouches | SAME | | Base Transport Medium | Modified Liquid Amies | SAME | | Transport Medium tube / volume | Plastic (polypropylene) / 1 mL | SAME | | Swab shaft | Plastic, pre-scored | SAME | | Amies Formulation | Sodium chloride Disodium phosphate Sodium thioglycolate Monopotassium phosphate Potassium chloride Calcium chloride Magnesium chloride | SAME | | pH | 7.3 ± 0.2 (range 7.1–7.5) | SAME | | Product Storage temperature (refrigerated and room) | 2–8°C, 20–25°C | SAME | | Shelf life | 18 months | SAME | | General Device Characteristic Differences | | | | Kit configuration | Medium tubes (50 count) in a kit box with blister peel pouches (50 count) with swabs inside | Single peel pouch containing sterile swab and Medium tube | | Swab tip | Microbrush Nylon Flocked Swab | HydraFlock Swab (Polyester) | ## VI Standards/Guidance Documents Referenced: Declaration of Conformity was provided by the sponsor via a signed, dated statement for the following standards. All requirements were met, no deviations from each applicable standard were applied and there were no differences between the tested device and the device to be marketed. | Document | FR Recognition Number | Title / Content | | --- | --- | --- | | CLSI M40-A2 (R2019) | 7-250 | Quality Control of Microbiological Transport Systems; Approved Standard – Second Edition (reaffirmed September 2019) | ## VII Performance Characteristics (if/when applicable): {4} # A Analytical Performance: Precision/Reproducibility, Linearity, Analytical Specificity/Interference, Assay Reportable Range, Detection Limit, Assay Cut-Off; Traceability, Expected Values (Controls, Calibrators, or Methods): Not Applicable # Shelf-life Stability: Shelf-life stability of four (4) manufactured lots of ARX Liquid Amies Collection & Transport System was evaluated at room temperature $(20 - 25^{\circ}\mathrm{C})$ in real time in support of claims of media stability prior to sample collection. Shelf-life stability tests included: (a) pH monitoring, (b) visual estimation of turbidity, and (c) viscosity measurement. Based on available data, the sponsor's claim of shelf-life stability of 18 months for the ARX Liquid Amies Collection & Transport System is acceptable. The pH of the ARX Liquid Amies Media was measured in real-time at monthly intervals from the date of manufacture (Table 1). Random tubes from independent lots stored at room temperature $(20 - 25^{\circ}\mathrm{C})$ were tested and found to maintain their pH within the specified range $(7.30\pm 0.2)$ . Table 1: Real-time Stability (20-25°C Storage) — pH Readings | Time (months) | Lot A030921 Manufactured 03/09/21 | Lot AR1001 Manufactured 01/07/22 | Lot AR1002 Manufactured 01/24/22 | Lot AR1003 Manufactured 02/04/22 | | --- | --- | --- | --- | --- | | 0 | 7.30 | 7.20 | 7.20 | 7.20 | | 1 | 7.30 | 7.20 | 7.20 | 7.20 | | 2 | 7.30 | 7.20 | 7.20 | 7.20 | | 3 | 7.30 | 7.20 | 7.20 | 7.20 | | 4 | 7.30 | 7.20 | 7.20 | 7.20 | | 5 | 7.30 | 7.20 | 7.20 | 7.20 | | 6 | 7.30 | 7.20 | 7.20 | 7.20 | | 7 | 7.30 | 7.20 | 7.20 | 7.20 | | 8 | 7.30 | 7.20 | 7.20 | 7.20 | | 9 | 7.30 | 7.20 | 7.20 | 7.20 | | 10 | 7.25 | 7.20 | 7.20 | 7.20 | | 11 | 7.25 | 7.15 | 7.15 | 7.15 | | 12 | 7.25 | 7.15 | 7.15 | 7.15 | | 13 | 7.25 | 7.15 | 7.15 | 7.15 | | 14 | 7.25 | 7.15 | 7.15 | 7.20 | | 15 | 7.20 | 7.10 | 7.15 | 7.15 | | 16 | 7.20 | 7.10 | 7.15 | 7.15 | | 17 | 7.20 | 7.10 | 7.10 | 7.15 | | 18 | 7.20 | 7.10 | 7.10 | 7.15 | Visual estimation of Turbidity of the ARX Liquid Amies Media was conducted in real-time at monthly intervals from the date of manufacture using random tubes from independent media lots K222613 - Page 5 of 18 {5} stored at room temperature $(20 - 25^{\circ}\mathrm{C})$ . All lots passed visual inspection with testing time ranging from time zero through 18 months for all 4 lots. The Viscosity of the ARX Liquid Amies Media was measured at a liquid temperature of approximately $20^{\circ}\mathrm{C}$ in 4-month intervals from the date of manufacture. Random tubes from independent lots stored at room temperature $(20 - 25^{\circ}\mathrm{C})$ were tested and found to maintain viscosity within a range of $1.075 \pm 0.015$ milliPascal.Second (Table 2). Table 2: Real-time Stability (20-25°C Storage) — Viscosity Readings in mPa.S at ${20}^{ \circ }\mathrm{C}$ | Time (months) | Lot A030921 Manufactured 03/09/21 | Lot AR1001 Manufactured 01/07/22 | Lot AR1002 Manufactured 01/24/22 | Lot AR1003 Manufactured 02/04/22 | | --- | --- | --- | --- | --- | | 0 | 1.08 | 1.09 | 1.08 | 1.08 | | 4 | 1.09 | 1.09 | 1.07 | 1.08 | | 8 | 1.06 | 1.07 | 1.06 | 1.07 | | 12 | 1.07 | 1.07 | 1.06 | 1.07 | | 16 | 1.05 | 1.07 | 1.07 | 1.08 | | 20 | 1.05 | 1.07 | 1.06 | 1.06 | # Specimen Stability: # Bacterial Recovery Studies: Performance of ARX Liquid Amies Collection & Transport System for bacterial recovery was determined using roll plate and swab elution methods, following the FDA-recognized sections of Clinical Laboratory Standards Institute (CLSI) M40-A2:2014 Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition. As shown in Table 3, a total of three (3) aerobic, six (6) facultative anaerobic (including one (1) fastidious organism), and eight (8) obligate anaerobic bacteria was included in the bacterial recovery studies. Additionally, Table 3 also lists the appropriate Negative Clinical Matrix (NCM) that was used in all these studies. For dilution of the inoculum, a subset of these organisms was tested in the presence of NCM or sterile saline (in a separate set where negative clinical matrix was omitted), whereas another subset of the organisms used saline only. The data indicated no impact on performance for the most challenging organisms when diluted in either matrix or saline. Additionally, justification was provided to support the claim that the subset of organisms tested in saline is expected to have equivalent performance in the presence of matrix. Performance was assessed using the Roll-Plate and Swab Elution methods. Manual colony counts were conducted for both at all time intervals for each swab-organism combination, and the mean count was recorded per anatomical site. Three (3) dilutions were analyzed for each test organism and the dilution yielding colony counts nearest 300 CFU at time zero was reported and/or used for mean CFU/mL estimations, following the recommendations of CLSI M40-A2 (sections 8.12.1, 8.12.3, and 8.12.4 for Roll-Plate studies; sections 8.11.1, 8.11.2, 8.11.4 for Swab Elution studies). Acceptance criteria for bacterial recovery (minimum acceptable viability of at least $2\%$ CFU relative to time 0 for Roll-plate studies; maximum $3\log_{10}$ decline in CFU acceptable relative to time 0 for Swab Elution studies) were followed as recommended in CLSI M40-A2. As discussed in the respective sections below and shown in Tables 4-11 below, the performance of all bacterial recovery, when used with or without NCM, was found to be acceptable. K222613 - Page 6 of 18 {6} Table 3: Bacterial strains used for Roll-Plate and Swab Elution studies in Negative Clinical Matrix (NCM) or Saline | Bacteria (ATCC Part #) | Characteristic | 0.5 McFarland suspension diluted with | | Matrix (Swab Types: NPS, nasopharyngeal, including tapered tip type; OPS, oropharyngeal) | | | --- | --- | --- | --- | --- | --- | | | | NCM | Saline | NCM | Saline | | Haemophilus influenzae (ATCC 10211) | Facultative anaerobe | 10-4 | 10-4 | Nasal Irrigation/Wash (NPS & OPS) | (NPS) | | Streptococcus pneumoniae (ATCC 6305) | Facultative anaerobe | 10-4 | 10-4 | Nasal Irrigation/Wash (NPS & OPS) | (NPS) | | Staphylococcus aureus (MRSA) (ATCC 43300) | Aerobe | 10-4 | 10-4 | Tears, Pooled Human Donors (NPS) | (NPS) | | Pseudomonas aeruginosa (ATCC BAA-427) | Aerobe | 10-4 | 10-4 | Auricular material/cerumen (NPS) | (NPS) | | Streptococcus agalactiae (Group B Strep) (ATCC 13813) | Aerobe | 10-4 | 10-4 | Vaginal & Rectal Swab (NPS & OPS) | (NPS) | | Neisseria gonorrhoeae (ATCC 43069) | Fastidious, facultative Anaerobe | 10-4 | 10-4 | Vaginal Swab (NPS & OPS); Urethral Swab (NPS) | (NPS) | | Bacteroides fragilis (ATCC 25285) | Anaerobe | 10-3 | 10-3 | Wound/Abcess (NPS & OPS) | (NPS) | | Fusobacterium nucleatum (ATCC 25586) | Anaerobe | 10-3 | 10-3 | Wound/Abcess (NPS & OPS) | (NPS) | | Streptococcus pyogenes (ATCC 19615) | Facultative anaerobe | | 10-4 | | (NPS) | | Propionibacterium acnes (ATCC 6919) | Facultative anaerobe | | 10-5 | | (NPS) | | Enterococcus faecalis (ATCC 51299) | Facultative anaerobe | | 10-4 | | (NPS) | | Peptostreptococcus anaerobius (ATCC 27337) | Anaerobe | | 10-3 | | (NPS) | | Prevotella melaninogenica (ATCC 25845) | Anaerobe | | 10-5 | | (NPS) | K222613 - Page 7 of 18 {7} | Bacteria (ATCC Part #) | Characteristic | 0.5 McFarland suspension diluted with | | Matrix (Swab Types: NPS, nasopharyngeal, including tapered tip type; OPS, oropharyngeal) | | | --- | --- | --- | --- | --- | --- | | | | NCM | Saline | NCM | Saline | | Clostridium perfringens (Strain S 107) (ATCC 13124) | Anaerobe | | 10^{-4} | | (NPS) | | Clostridium sporogenes (ATCC 3584) | Anaerobe | | 10^{-4} | | (NPS) | | Finegoldia magna (Strain WAL2508) (ATCC 29328) | Anaerobe | | 10^{-4} | | (NPS) | | Fusobacterium necrophorum (ATCC 25286) | Anaerobe | | 10^{-4} | | (NPS) | ## Roll-Plate Method: For the roll-plate method, bacterial suspensions were prepared to approximately 0.5 McFarland standard in NCM (as indicated in Table 3) followed by 10-fold serial dilutions in pooled NCM. The performance characteristics of ARX Liquid Amies Collection & Transport System were determined using procedures outlined in CLSI M40-A2 using three sterile flocked swab types (i.e., NPS, nasopharyngeal swab, with or without tapered tip design; OPS, oropharyngeal swab) designed for throat, urogenital and nasal specimen collection. This study was conducted at two different temperatures to reflect refrigerated (2–8°C) and room temperature (25–30°C) conditions in NCM and used three (3) independent lots of ARX Liquid Amies representing old (Lot #A030921, post-production age at study: 23–24 months), middle-aged (Lot #AR1002, age: 6–7 months), and newly manufactured (Lot #A1229222, age: 1–2 months) lots. The swabs from each transport system were inoculated in triplicate with a specified volume of select bacterial suspensions prepared in NCM and saline or in saline only. These swabs were then placed in their respective transport vial and held for 0, 24, and 48 hrs. (except *Neisseria gonorrhoeae* held only for 24 hrs.); at the designated time intervals the swabs were removed and processed for recovery of bacterial CFU counts (refer to Table 4 and Table 5). Additional set of roll-plate testing was performed using 0.5 McFarland suspensions prepared and serially diluted in sterile saline to the desired concentration. The performance characteristics of ARX Liquid Amies Collection & Transport System in saline were determined as above using the two NPS types. This study was conducted at two different temperatures to reflect refrigerated (2–8°C) and ambient temperature (20–25°C) conditions in saline, along with the addition of additional bacterial strains (as indicated in Table 3), and used three (3) independent lots of ARX Liquid Amies representing old (Lot #A030921; post-production age at study: 17 months), middle-aged (Lot #AR1001/2/3, age:6–7 months), and newly manufactured (Lot #A061422, age: 2 months) lots. The swabs from each transport system were inoculated in triplicate with a specified volume of select bacterial suspensions prepared in sterile saline, placed in their respective transport vials, and held for 0, 24, and 48 hrs. (except *Neisseria gonorrhoeae* held only for 24 hrs.); at the designated time intervals the swabs were removed and processed for recovery of bacterial CFU counts (refer to Table 6 and Table 7). K222613 - Page 8 of 18 {8} Table 4: Roll-Plate Method of Bacterial Recovery following Storage at Refrigerated (2–8°C) Conditions using NCM. | Organism (ATCC Part #) | Lot Age | Average CFUs Recovered: Time 0 hr. | Average CFUs Recovered: Time 24 hrs. | Average CFUs Recovered: Time 48 hrs. | | --- | --- | --- | --- | --- | | Haemophilus influenzae (ATCC 10211) | Old | 219 | 186 | 87 | | | Middle | 226 | 191 | 93 | | | New | 223 | 191 | 91 | | Streptococcus pneumoniae (ATCC 6305) | Old | 259 | 226 | 110 | | | Middle | 254 | 223 | 109 | | | New | 261 | 228 | 113 | | Staphylococcus aureus (MRSA) (ATCC 43300) | Old | 228 | 140 | 77 | | | Middle | 242 | 135 | 72 | | | New | 247 | 145 | 79 | | Pseudomonas aeruginosa (ATCC BAA-427) | Old | 268 | 256 | 119 | | | Middle | 276 | 258 | 128 | | | New | 290 | 269 | 124 | | Neisseria gonorrhoeae (ATCC 43069) | Old | 267 | 136 | | | | Middle | 269 | 138 | | | | New | 281 | 146 | | | Streptococcus agalactiae (Group B Strep) (ATCC 13813) | Old | 275 | 134 | 53 | | | Middle | 276 | 132 | 56 | | | New | 281 | 136 | 55 | | Bacteroides fragilis (ATCC 25285) | Old | 258 | 181 | 73 | | | Middle | 258 | 183 | 79 | | | New | 261 | 185 | 81 | | Fusobacterium nucleatum (ATCC 25586) | Old | 223 | 156 | 32 | | | Middle | 228 | 165 | 37 | | | New | 233 | 166 | 40 | * Neisseria gonorrhoeae recovery tested only at 24 hrs. Table 5: Roll-Plate Method of Bacterial Recovery following Storage at Room Temperature (25–30°C) Conditions using NCM. | Organism (ATCC Part #) | Lot Age | Average CFUs Recovered: Time 0 hr. | Average CFUs Recovered: Time 24 hrs. | Average CFUs Recovered: Time 48 hrs. | | --- | --- | --- | --- | --- | | Haemophilus influenzae (ATCC 10211) | Old | 216 | 170 | 64 | | | Middle | 218 | 163 | 63 | | | New | 225 | 176 | 72 | | Streptococcus pneumoniae (ATCC 6305) | Old | 218 | 144 | 63 | | | Middle | 229 | 149 | 62 | | | New | 233 | 148 | 63 | | Staphylococcus aureus (MRSA) (ATCC 43300) | Old | 243 | 135 | 59 | | | Middle | 239 | 143 | 67 | | | New | 249 | 145 | 69 | K222613 - Page 9 of 18 {9} | Organism (ATCC Part #) | Lot Age | Average CFUs Recovered: Time 0 hr. | Average CFUs Recovered: Time 24 hrs. | Average CFUs Recovered: Time 48 hrs. | | --- | --- | --- | --- | --- | | Pseudomonas aeruginosa (ATCC BAA-427) | Old | 286 | 234 | 106 | | | Middle | 287 | 236 | 105 | | | New | 293 | 246 | 106 | | Neisseria gonorrhoeae (ATCC 43069) | Old | 251 | 137 | | | | Middle | 266 | 142 | | | | New | 262 | 142 | | | Streptococcus agalactiae (Group B Strep) (ATCC 13813) | Old | 285 | 118 | 52 | | | Middle | 290 | 123 | 52 | | | New | 287 | 117 | 52 | | Bacteroides fragilis (ATCC 25285) | Old | 281 | 177 | 92 | | | Middle | 276 | 175 | 89 | | | New | 278 | 181 | 97 | | Fusobacterium nucleatum (ATCC 25586) | Old | 204 | 150 | 40 | | | Middle | 214 | 153 | 37 | | | New | 222 | 151 | 43 | * Neisseria gonorrhoeae recovery tested only at 24 hrs. Table 6: Roll-Plate Method of Bacterial Recovery following Storage at Refrigerated (2–8°C) Conditions using Saline. | Organism (ATCC Part #) | Lot Age | Average CFUs Recovered: Time 0 hr. | Average CFUs Recovered: Time 24 hrs. | Average CFUs Recovered: Time 48 hrs. | | --- | --- | --- | --- | --- | | Streptococcus pyogenes (ATCC 19615) | Old | 249 | 247 | 135 | | | Middle | 239 | 177 | 105 | | | New | 195 | 199 | 94 | | Peptostreptococcus anaerobius (ATCC 27337) | Old | 215 | 163 | 38 | | | Middle | 261 | 180 | 32 | | | New | 214 | 144 | 37 | | Propionibacterium acnes (ATCC 6919) | Old | 257 | 163 | 42 | | | Middle | 275 | 159 | 37 | | | New | 230 | 137 | 34 | | Prevotella melaninogenica (ATCC 25845) | Old | 259 | 121 | 27 | | | Middle | 247 | 126 | 34 | | | New | 260 | 119 | 33 | | Enterococcus faecalis (ATCC 51299) | Old | 236 | 114 | 38 | | | Middle | 252 | 108 | 35 | | | New | 237 | 113 | 43 | | Clostridium perfringens (Strain S-107) (ATCC 13124) | Old | 280 | 146 | 44 | | | Middle | 288 | 161 | 51 | | | New | 289 | 158 | 42 | | Clostridium sporogenes (ATCC 3584) | Old | 245 | 97 | 39 | | | Middle | 251 | 93 | 38 | | | New | 238 | 97 | 34 | K222613 - Page 10 of 18 {10} | Organism (ATCC Part #) | Lot Age | Average CFUs Recovered: Time 0 hr. | Average CFUs Recovered: Time 24 hrs. | Average CFUs Recovered: Time 48 hrs. | | --- | --- | --- | --- | --- | | Finegoldia magna (Strain WAL2508) (ATCC 29328) | Old | 273 | 150 | 48 | | | Middle | 280 | 142 | 44 | | | New | 274 | 143 | 52 | | Fusobacterium necrophorum (ATCC 25286) | Old | 283 | 144 | 56 | | | Middle | 288 | 146 | 51 | | | New | 275 | 150 | 53 | | Pseudomonas aeruginosa (ATCC BAA-427) | Old | 305 | 270 | 95 | | | Middle | 284 | 241 | 92 | | | New | 299 | 274 | 86 | | Streptococcus pneumoniae (ATCC 6305) | Old | 253 | 230 | 110 | | | Middle | 246 | 216 | 85 | | | New | 214 | 171 | 68 | | Haemophilus influenzae (ATCC 10211) | Old | 210 | 184 | 88 | | | Middle | 229 | 195 | 74 | | | New | 223 | 189 | 73 | | Bacteroides fragilis (ATCC 25285) | Old | 302 | 215 | 107 | | | Middle | 247 | 181 | 82 | | | New | 273 | 192 | 99 | | Fusobacterium nucleatum (ATCC 25586) | Old | 232 | 160 | 32 | | | Middle | 237 | 156 | 31 | | | New | 212 | 136 | 26 | | Neisseria gonorrhoeae (ATCC 43069) | Old | 273 | 120 | | | | Middle | 267 | 133 | | | | New | 268 | 130 | | | Staphylococcus aureus (MRSA) (ATCC 43300) | Old | 255 | 145 | 76 | | | Middle | 249 | 131 | 61 | | | New | 254 | 126 | 63 | | Streptococcus agalactiae (Group B Strep) (ATCC 13813) | Old | 299 | 128 | 50 | | | Middle | 292 | 122 | 47 | | | New | 307 | 128 | 53 | * Neisseria gonorrhoeae recovery tested only at 24 hrs. Table 7: Roll-Plate Method of Bacterial Recovery following Storage at Room Temperature (20–25°C) Conditions using Saline. | Organism (ATCC Part #) | Lot Age | Average CFUs Recovered: Time 0 hr. | Average CFUs Recovered: Time 24 hrs. | Average CFUs Recovered: Time 48 hrs. | | --- | --- | --- | --- | --- | | Streptococcus pyogenes (ATCC 19615) | Old | 254 | 227 | 120 | | | Middle | 230 | 177 | 98 | | | New | 199 | 193 | 84 | | Peptostreptococcus anaerobius (ATCC 27337) | Old | 223 | 150 | 32 | | | Middle | 248 | 176 | 40 | | | New | 220 | 140 | 29 | K222613 - Page 11 of 18 {11} K222613 - Page 12 of 18 | Organism (ATCC Part #) | Lot Age | Average CFUs Recovered: Time 0 hr. | Average CFUs Recovered: Time 24 hrs. | Average CFUs Recovered: Time 48 hrs. | | --- | --- | --- | --- | --- | | Propionibacterium acnes (ATCC 6919) | Old | 253 | 163 | 44 | | | Middle | 258 | 157 | 38 | | | New | 225 | 128 | 31 | | Prevotella melaninogenica (ATCC 25845) | Old | 261 | 122 | 31 | | | Middle | 252 | 119 | 39 | | | New | 268 | 127 | 44 | | Enterococcus faecalis (ATCC 51299) | Old | 238 | 119 | 39 | | | Middle | 259 | 107 | 43 | | | New | 241 | 112 | 37 | | Clostridium perfringens (Strain S-107) (ATCC 13124) | Old | 276 | 152 | 48 | | | Middle | 283 | 164 | 53 | | | New | 280 | 159 | 56 | | Clostridium sporogenes (ATCC 3584) | Old | 253 | 106 | 45 | | | Middle | 244 | 97 | 42 | | | New | 236 | 92 | 37 | | Finegoldia magna (Strain WAL2508) (ATCC 29328) | Old | 183 | 124 | 67 | | | Middle | 173 | 122 | 64 | | | New | 187 | 127 | 62 | | Fusobacterium necrophorum (ATCC 25286) | Old | 273 | 136 | 39 | | | Middle | 281 | 142 | 32 | | | New | 279 | 140 | 42 | | Pseudomonas aeruginosa (ATCC BAA-427) | Old | 299 | 298 | 99 | | | Middle | 292 | 288 | 102 | | | New | 300 | 298 | 103 | | Streptococcus pneumoniae (ATCC 6305) [10^{-4}] | Old | 234 | 137 | 59 | | | Middle | 227 | 147 | 67 | | | New | 209 | 148 | 53 | | Haemophilus influenzae (ATCC 10211) | Old | 224 | 170 | 64 | | | Middle | 216 | 172 | 71 | | | New | 215 | 157 | 51 | | Bacteroides fragilis (ATCC 25285) | Old | 298 | 209 | 95 | | | Middle | 240 | 179 | 73 | | | New | 270 | 188 | 83 | | Fusobacterium nucleatum (ATCC 25586) | Old | 230 | 152 | 31 | | | Middle | 222 | 145 | 35 | | | New | 202 | 116 | 22 | | Neisseria gonorrhoeae (ATCC 43069) | Old | 250 | 131 | | | | Middle | 270 | 138 | | | | New | 268 | 135 | | | Staphylococcus aureus (MRSA) (ATCC 43300) | Old | 252 | 141 | 70 | | | Middle | 246 | 134 | 58 | | | New | 247 | 121 | 56 | | | Old | 284 | 115 | 53 | | | Middle | 289 | 122 | 54 | {12} | Organism (ATCC Part #) | Lot Age | Average CFUs Recovered: Time 0 hr. | Average CFUs Recovered: Time 24 hrs. | Average CFUs Recovered: Time 48 hrs. | | --- | --- | --- | --- | --- | | Streptococcus agalactiae (Group B Strep) (ATCC 13813) | New | 290 | 117 | 47 | * Neisseria gonorrhoeae recovery tested only at 24 hrs. ## Swab Elution Method: For the Swab-Elution method, bacterial suspensions were prepared in NCM similar to the roll-plate method (as indicated in Table 3). The performance characteristics of ARX Liquid Amies Collection & Transport System were determined using the procedures outlined in CLSI M40-A2 using three sterile flocked swab types (i.e., NPS, nasopharyngeal swab, with or without tapered tip design; OPS, oropharyngeal swab) designed for throat, urogenital and nasal specimen collection. This study was conducted at two different temperatures to reflect refrigerated (2–8°C) and room temperature (25–30°C) conditions in NCM and used three (3) independent lots of ARX Liquid Amies representing old (Lot #A030921, post-production age at study: 23–24 months), middle-aged (Lot #AR1002, age: 6–7 months), and newly manufactured (Lot #A1229222, age: 1–2 months) lots. The swabs from each transport system were inoculated in triplicate with a specified volume of select bacterial suspensions prepared either in NCM or in saline or in saline only. These swabs were then placed in their respective transport vial and held for 0, 24, and 48 hrs. (except *Neisseria gonorrhoeae* held only for 24 hrs.); at the designated time intervals the swabs were removed and processed for recovery of bacterial CFU/mL counts (refer to Table 8 and Table 9). Additional swab elution testing was performed using bacterial suspensions prepared and serially diluted in sterile saline to the desired concentration. The performance characteristics of ARX Liquid Amies Collection & Transport System in saline were determined as above using the two NPS types. This study was conducted at two different temperatures to reflect refrigerated (2–8°C) and room temperature (20–25°C) conditions in saline, along with the addition of additional bacterial strains (as indicated in Table 3), and used three (3) independent lots of ARX Liquid Amies representing old (Lot #A030921; post-production age at study: 17 months), middle-aged (Lot #AR1001/2/3, age:6–7 months), and newly manufactured (Lot #A061422, age: 2 months) lots. The swabs from each transport system were inoculated in triplicate with a specified volume of select bacterial suspensions prepared in sterile saline, placed in their respective transport vials, and held for 0, 24, and 48 hrs. (except *Neisseria gonorrhoeae* held only for 24 hrs.); at the designated time intervals the swabs were removed and processed for recovery of bacterial CFU counts (refer to Table 10 and Table 11). K222613 - Page 13 of 18 {13} Table 8: Swab Elution Method of Bacterial Recovery following Storage at Refrigerated (2- $8^{\circ}\mathrm{C}$ ) Conditions using NCM. | Organism (ATCC Part #) | Lot Age | Average CFU/mL Recovery: Time 0 hr. | Average CFU/mL Recovery: Time 24 hrs. | Average CFU/mL Recovery: Time 48 hrs. | Change in Log10(0-48 hrs.)* | | --- | --- | --- | --- | --- | --- | | Haemophilus influenzae (ATCC 10211) | Old | 2.84E+07 | 1.03E+07 | 3.58E+06 | -0.90 | | | Middle | 3.00E+07 | 1.08E+07 | 4.05E+06 | -0.87 | | | New | 3.05E+07 | 1.12E+07 | 4.08E+06 | -0.87 | | Streptococcus pneumoniae (ATCC 6305) | Old | 1.62E+07 | 5.43E+06 | 2.18E+06 | -0.87 | | | Middle | 1.85E+07 | 5.58E+06 | 2.23E+06 | -0.92 | | | New | 1.94E+07 | 5.72E+06 | 2.20E+06 | -0.94 | | Staphylococcus aureus (MRSA) (ATCC 43300) | Old | 2.40E+07 | 5.40E+06 | 3.03E+06 | -0.90 | | | Middle | 2.59E+07 | 6.30E+06 | 3.60E+06 | -0.86 | | | New | 2.65E+07 | 7.23E+06 | 3.23E+06 | -0.91 | | Pseudomonas aeruginosa (ATCC BAA-427) | Old | 1.10E+07 | 8.80E+06 | 4.00E+06 | -0.44 | | | Middle | 1.21E+07 | 9.90E+06 | 4.00E+06 | -0.48 | | | New | 1.29E+07 | 1.02E+07 | 4.67E+06 | -0.44 | | Neisseria gonorrhoeae (ATCC 43069) | Old | 2.97E+07 | 2.06E+07 | | -0.85 | | | Middle | 3.12E+07 | 2.19E+07 | | -0.77 | | | New | 3.21E+07 | 2.22E+07 | | -0.74 | | Streptococcus agalactiae (Group B Strep) (ATCC 13813) | Old | 1.56E+07 | 8.29E+06 | 4.48E+06 | -0.54 | | | Middle | 1.63E+07 | 9.24E+06 | 5.19E+06 | -0.50 | | | New | 1.66E+07 | 9.73E+06 | 5.30E+06 | -0.49 | | Bacteroides fragilis (ATCC 25285) | Old | 2.40E+06 | 1.89E+06 | 8.00E+05 | -0.48 | | | Middle | 2.49E+06 | 1.88E+06 | 8.03E+05 | -0.49 | | | New | 2.47E+06 | 1.88E+06 | 8.18E+05 | -0.48 | | Fusobacterium nucleatum (ATCC 25586) | Old | 2.26E+06 | 1.37E+06 | 3.37E+05 | -0.83 | | | Middle | 2.32E+06 | 1.40E+06 | 3.38E+05 | -0.84 | | | New | 2.28E+06 | 1.40E+06 | 3.42E+05 | -0.82 | * Neisseria gonorrhoeae Change in $\operatorname{Log}_{10}$ is (0–24 hrs.) Table 9: Swab Elution Method of Bacterial Recovery following Storage at Room Temperature (25–30°C) Conditions using NCM. | Organism (ATCC Part #) | Lot Age | Average CFU/mL Recovery: Time 0 hr. | Average CFU/mL Recovery: Time 24 hrs. | Average CFU/mL Recovery: Time 48 hrs. | Change in Log10(0-48 hrs.)* | | --- | --- | --- | --- | --- | --- | | Haemophilus influenzae (ATCC 10211) | Old | 2.22E+07 | 1.67E+07 | 6.32E+06 | -0.54 | | | Middle | 2.22E+07 | 1.62E+07 | 5.98E+06 | -0.57 | | | New | 2.42E+07 | 1.66E+07 | 5.82E+06 | -0.62 | | Streptococcus pneumoniae (ATCC 6305) | Old | 2.25E+07 | 1.35E+07 | 5.37E+06 | -0.62 | | | Middle | 2.33E+07 | 1.43E+07 | 6.48E+06 | -0.55 | | | New | 2.37E+07 | 1.41E+07 | 6.08E+06 | -0.59 | K222613 - Page 14 of 18 {14} Table 10: Swab Elution Method of Bacterial Recovery following Storage at Refrigerated $(2 - 8^{\circ}\mathrm{C})$ Conditions in Saline. | Organism (ATCC Part #) | Lot Age | Average CFU/mL Recovery: Time 0 hr. | Average CFU/mL Recovery: Time 24 hrs. | Average CFU/mL Recovery: Time 48 hrs. | Change in Log10(0-48 hrs.)* | | --- | --- | --- | --- | --- | --- | | Staphylococcus aureus (MRSA) (ATCC 43300) | Old | 5.90E+06 | 2.77E+06 | 6.33E+05 | -0.97 | | | Middle | 6.30E+06 | 2.97E+06 | 8.00E+05 | -0.90 | | | New | 6.13E+06 | 2.93E+06 | 7.33E+05 | -0.92 | | Pseudomonas aeruginosa (ATCC BAA-427) | Old | 1.63E+06 | 8.73E+05 | 1.53E+05 | -1.03 | | | Middle | 1.62E+06 | 8.20E+05 | 1.47E+05 | -1.04 | | | New | 1.57E+06 | 7.07E+05 | 1.33E+05 | -1.07 | | Bacteroides fragilis (ATCC 25285) | Old | 3.27E+08 | 1.27E+08 | 4.37E+07 | -0.87 | | | Middle | 3.18E+08 | 1.17E+08 | 3.80E+07 | -0.92 | | | New | 3.25E+08 | 1.28E+08 | 3.07E+07 | -1.02 | | Pseudomonas aeruginosa (ATCC 43069) | Old | 2.95E+08 | 7.57E+07 | 2.40E+07 | -1.09 | | | Middle | 2.89E+08 | 7.53E+07 | 3.17E+07 | -0.96 | | | New | 2.92E+08 | 9.03E+07 | 3.57E+07 | -0.91 | | Enterococcus faecalis (ATCC 51299) | Old | 1.42E+07 | 8.00E+06 | 2.60E+06 | -0.74 | | | Middle | 1.45E+07 | 7.47E+06 | 2.83E+06 | -0.71 | | | New | 1.48E+07 | 7.43E+06 | 2.73E+06 | -0.73 | | Staphylococcus aureus (MRSA) (ATCC 43300) | Old | 2.11E+07 | 1.86E+07 | 8.03E+06 | -0.42 | | | Middle | 2.18E+07 | 1.91E+07 | 7.53E+06 | -0.46 | | | New | 2.10E+07 | 1.85E+07 | 8.07E+06 | -0.42 | | Staphylococcus aureus (ATCC BAA-427) | Old | 1.52E+07 | 8.40E+06 | 4.20E+06 | -0.56 | | | Middle | 1.64E+07 | 9.33E+06 | 5.20E+06 | -0.50 | | | New | 1.66E+07 | 9.70E+06 | 5.37E+06 | -0.49 | | Neisseria gonorrhoeae (ATCC 43069) | Old | 2.67E+07 | 1.91E+07 | | -0.99 | | | Middle | 2.73E+07 | 1.04E+07 | | -0.42 | | | New | 2.78E+07 | 1.01E+07 | | -0.44 | | Streptococcus agalactiae (Group B Strep) (ATCC 13813) | Old | 1.60E+07 | 6.90E+06 | 4.03E+06 | -0.60 | | | Middle | 1.67E+07 | 7.45E+06 | 4.23E+06 | -0.60 | | | New | 1.71E+07 | 8.44E+06 | 4.40E+06 | -0.59 | | Bacteroides fragilis (ATCC 25285) | Old | 2.83E+06 | 1.87E+06 | 7.58E+05 | -0.57 | | | Middle | 2.86E+06 | 1.91E+06 | 8.18E+05 | -0.54 | | | New | 2.93E+06 | 1.94E+06 | 8.25E+05 | -0.55 | | Fusobacterium nucleatum (ATCC 25586) | Old | 2.11E+06 | 1.54E+06 | 3.50E+05 | -0.78 | | | Middle | 2.16E+06 | 1.54E+06 | 3.45E+05 | -0.80 | | | New | 2.21E+06 | 1.54E+06 | 3.60E+05 | -0.79 | * Neisseria gonorrhoeae Change in $\operatorname{Log}_{10}$ is (0–24 hrs.) K222613 - Page 15 of 18 {15} | Organism (ATCC Part #) | Lot Age | Average CFU/mL Recovery: Time 0 hr. | Average CFU/mL Recovery: Time 24 hrs. | Average CFU/mL Recovery: Time 48 hrs. | Change in Log10(0-48 hrs.)* | | --- | --- | --- | --- | --- | --- | | Clostridium perfringens(Strain S-107)(ATCC 13124) | Old | 2.98E+07 | 1.19E+07 | 3.30E+06 | -0.96 | | | Middle | 2.91E+06 | 1.24E+07 | 4.20E+06 | -0.84 | | | New | 3.00E+07 | 1.29E+07 | 4.13E+06 | -0.86 | | Clostridium sporogenes(ATCC 3584) | Old | 2.83E+07 | 1.75E+07 | 8.43E+06 | -0.53 | | | Middle | 2.74E+07 | 1.74E+07 | 9.07E+06 | -0.48 | | | New | 2.89E+07 | 1.80E+07 | 6.20E+06 | -0.67 | | Finegoldia magna(Strain WAL2508)(ATCC 29328) | Old | 2.02E+07 | 8.53E+06 | 3.13E+06 | -0.81 | | | Middle | 2.10E+07 | 6.90E+06 | 3.03E+06 | -0.84 | | | New | 2.19E+07 | 7.57E+06 | 2.60E+06 | -0.93 | | Fusobacterium necrophorum(ATCC 25286) | Old | 2.92E+07 | 1.51E+07 | 5.83E+06 | -0.70 | | | Middle | 3.02E+07 | 1.52E+07 | 5.57E+06 | -0.73 | | | New | 2.98E+07 | 1.56E+07 | 3.40E+06 | -0.94 | | Pseudomonas aeruginosa(ATCC BAA-427) | Old | 1.02E+06 | 9.43E+05 | 2.70E+05 | -0.58 | | | Middle | 1.01E+06 | 9.43E+05 | 2.87E+05 | -0.55 | | | New | 1.03E+06 | 9.47E+05 | 2.93E+05 | -0.55 | | Streptococcus pneumoniae(ATCC 6305) | Old | 1.83E+06 | 4.70E+05 | 1.60E+05 | -1.06 | | | Middle | 1.75E+06 | 4.83E+05 | 1.40E+05 | -1.10 | | | New | 1.86E+06 | 4.83E+05 | 1.63E+05 | -1.06 | | Haemophilus influenzae(ATCC 10211) | Old | 3.07E+06 | 8.17E+05 | 3.37E+05 | -0.96 | | | Middle | 3.13E+06 | 9.40E+05 | 3.03E+05 | -1.01 | | | New | 3.11E+06 | 9.53E+05 | 3.13E+05 | -1.00 | | Bacteroides fragilis(ATCC 25285) | Old | 9.50E+04 | 3.60E+04 | 1.50E+04 | -0.80 | | | Middle | 8.70E+04 | 3.27E+04 | 1.63E+04 | -0.73 | | | New | 8.63E+04 | 4.10E+04 | 1.57E+04 | -0.74 | | Fusobacterium nucleatum(ATCC 25586) | Old | 2.33E+05 | 6.43E+04 | 1.70E+04 | -1.14 | | | Middle | 2.25E+05 | 6.03E+04 | 1.70E+04 | -1.12 | | | New | 2.22E+05 | 6.67E+04 | 1.97E+04 | -1.05 | | Neisseria gonorrhoeae(ATCC 43069) | Old | 3.23E+06 | 2.13E+06 | | -0.18 | | | Middle | 3.21E+06 | 2.05E+06 | | -0.19 | | | New | 3.24E+06 | 1.99E+06 | | -0.21 | | Staphylococcus aureus(MRSA)(ATCC 43300) | Old | 8.00E+05 | 2.60E+05 | 1.00E+05 | -1.19 | | | Middle | 7.47E+05 | 2.83E+05 | 1.03E+05 | -1.08 | | | New | 7.43E+05 | 2.73E+05 | 9.00E+04 | -1.09 | | Streptococcus agalactiae(Group B Strep)(ATCC 13813) | Old | 1.64E+06 | 8.37E+05 | 4.77E+05 | -0.54 | | | Middle | 1.56E+06 | 8.37E+05 | 4.20E+05 | -0.57 | | | New | 1.65E+06 | 8.17E+05 | 5.13E+05 | -0.51 | * Neisseria gonorrhoeae Change in $\operatorname{Log}_{10}$ is (0–24 hrs.) K222613 - Page 16 of 18 {16} Table 11: Swab Elution Method of Bacterial Recovery following Storage at Room Temperature (20–25°C) Conditions using Saline. | Organism (ATCC Part #) | Lot Age | Average CFU/mL Recovery: Time 0 hr. | Average CFU/mL Recovery: Time 24 hrs. | Average CFU/mL Recovery: Time 48 hrs. | Change in Log_{10} (0–48 hrs.)* | | --- | --- | --- | --- | --- | --- | | Streptococcus pyogenes (ATCC 19615) | Old | 2.54E+07 | 2.27E+07 | 1.20E+07 | -0.32 | | | Middle | 2.30E+07 | 1.93E+07 | 9.70E+06 | -0.38 | | | New | 1.99E+07 | 1.77E+07 | 7.73E+06 | -0.41 | | Peptostreptococcus anaerobius (ATCC 27337) | Old | 2.23E+06 | 1.50E+06 | 3.20E+05 | -0.84 | | | Middle | 2.48E+06 | 1.76E+06 | 4.03E+05 | -0.79 | | | New | 2.20E+06 | 1.40E+06 | 2.93E+05 | -0.88 | | Propionibacterium acnes (ATCC 6919) | Old | 2.53E+08 | 1.63E+08 | 4.37E+07 | -0.76 | | | Middle | 2.58E+08 | 1.57E+08 | 3.80E+07 | -0.83 | | | New | 2.25E+08 | 1.28E+08 | 3.07E+07 | -0.86 | | Prevotella melaninogenica (ATCC 25845) | Old | 2.61E+08 | 1.22E+08 | 3.07E+07 | -0.93 | | | Middle | 2.52E+08 | 1.19E+08 | 3.90E+07 | -0.81 | | | New | 2.68E+08 | 1.27E+08 | 4.40E+07 | -0.79 | | Enterococcus faecalis (ATCC 51299) | Old | 1.71E+07 | 5.63E+06 | 3.30E+06 | -0.71 | | | Middle | 1.58E+07 | 5.97E+06 | 3.67E+06 | -0.64 | | | New | 1.68E+07 | 5.47E+06 | 3.00E+06 | -0.75 | | Clostridium perfringens (Strain S-107) (ATCC 13124) | Old | 2.75E+06 | 1.43E+07 | 4.83E+06 | -0.76 | | | Middle | 2.69E+07 | 1.43E+07 | 4.50E+06 | -0.78 | | | New | 2.78E+07 | 1.46E+07 | 4.20E+06 | -0.82 | | Clostridium sporogenes (ATCC 3584) | Old | 2.62E+07 | 1.42E+07 | 5.87E+06 | -0.65 | | | Middle | 2.50E+07 | 1.34E+07 | 5.07E+06 | -0.69 | | | New | 2.58E+07 | 1.51E+07 | 5.17E+06 | -0.70 | | Finegoldia magna (Strain WAL2508) (ATCC 29328) | Old | 1.94E+07 | 7.17E+06 | 6.37E+06 | -0.48 | | | Middle | 1.88E+07 | 6.93E+06 | 6.53E+06 | -0.46 | | | New | 1.97E+07 | 6.33E+06 | 6.07E+06 | -0.51 | | Fusobacterium necrophorum (ATCC 25286) | Old | 2.92E+07 | 1.48E+07 | 5.57E+06 | -0.72 | | | Middle | 2.78E+07 | 1.44E+07 | 5.23E+06 | -0.72 | | | New | 2.72E+07 | 1.59E+07 | 4.60E+06 | -0.77 | | Pseudomonas aeruginosa (ATCC BAA-427) | Old | 1.26E+06 | 1.68E+06 | 1.22E+06 | -0.53 | | | Middle | 1.35E+06 | 1.68E+06 | 1.19E+06 | -0.51 | | | New | 1.16E+06 | 1.55E+06 | 1.10E+06 | -0.53 | | Streptococcus pneumoniae (ATCC 6305) | Old | 2.34E+06 | 1.37E+06 | 5.60E+05 | -0.62 | | | Middle | 2.27E+06 | 1.47E+06 | 6.67E+05 | -0.53 | | | New | 2.09E+06 | 1.47E+06 | 5.27E+05 | -0.60 | | Haemophilus influenzae (ATCC 10211) | Old | 2.24E+06 | 1.70E+06 | 6.43E+05 | -0.54 | | | Middle | 2.16E+06 | 1.72E+06 | 7.10E+05 | -0.48 | | | New | 2.15E+06 | 1.57E+06 | 5.13E+05 | -0.62 | | Bacteroides fragilis (ATCC 25285) | Old | 2.98E+05 | 2.09E+05 | 7.50E+04 | -0.60 | | | Middle | 2.40E+05 | 1.79E+05 | 7.30E+04 | -0.52 | | | New | 2.70E+05 | 1.88E+05 | 8.27E+04 | -0.51 | K222613 - Page 17 of 18 {17} | Organism (ATCC Part #) | Lot Age | Average CFU/mL Recovery: Time 0 hr. | Average CFU/mL Recovery: Time 24 hrs. | Average CFU/mL Recovery: Time 48 hrs. | Change in Log_{10} (0–48 hrs.)* | | --- | --- | --- | --- | --- | --- | | Fusobacterium nucleatum (ATCC 25586) | Old | 2.30E+05 | 1.52E+05 | 3.13E+04 | -0.87 | | | Middle | 2.22E+05 | 1.45E+05 | 3.47E+04 | -0.81 | | | New | 2.02E+05 | 1.16E+05 | 2.40E+04 | -0.93 | | Neisseria gonorrhoeae (ATCC 43069) | Old | 2.60E+06 | 9.40E+05 | | -0.44 | | | Middle | 2.80E+06 | 9.43E+05 | | -0.47 | | | New | 2.92E+06 | 9.67E+05 | | -0.48 | | Staphylococcus aureus (MRSA) (ATCC 43300) | Old | 2.05E+06 | 1.92E+06 | 8.43E+05 | -0.39 | | | Middle | 2.20E+06 | 1.99E+06 | 7.63E+05 | -0.46 | | | New | 2.20E+06 | 1.95E+06 | 7.83E+05 | -0.45 | | Streptococcus agalactiae (Group B Strep) (ATCC 13813) | Old | 1.72E+06 | 7.80E+05 | 4.47E+05 | -0.58 | | | Middle | 1.37E+06 | 5.10E+05 | 3.77E+05 | -0.56 | | | New | 1.74E+06 | 7.90E+05 | 4.43E+05 | -0.59 | * Neisseria gonorrhoeae Change in $\mathrm{Log}_{10}$ is (0–24 hrs.) Conclusions from Bacterial Recovery Studies: Using both the Roll-Plate and Swab Elution Methods, the ARX Liquid Amies Collection & Transport System showed recovery of bacteria within the acceptance criteria comparable to the predicate device for all holding temperatures tested. This demonstrates the acceptability of a stability claim of up to 48 hours for all organisms (except 24 hours for Neisseria gonorrhoeae) in clinical samples during storage and/or transport in this transport system. B Comparison Studies: Method Comparison with Predicate Device, Matrix Comparison: Not Applicable C Clinical Studies: Clinical Sensitivity, Clinical Specificity, Other Clinical Supportive Data, Clinical Cut-Off, Expected Values/Reference Ranges: Not Applicable VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K222613 - Page 18 of 18