(139 days)
The Visby Medical Men's Sexual Health Test is a single-use (disposable), fully integrated, automated Polymerase Chain Reaction (PCR) in vitro diagnostic test for the rapid detection and differentiation of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae in male urine specimens. The test results are to aid in the diagnosis of symptomatic or asymptomatic infections with Chlamydia trachomatis and Neisseria gonorrhoeae in males.
The Visby Medical Men's Sexual Health Test is a single-use (disposable), fully automated, rapid, compact device that contains PCR assays for qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) DNA in male urine samples from symptomatic or asymptomatic individuals. The device automatically performs all steps required to complete lysis, PCR amplification, and detection.
The Visby Medical Men's Sexual Health Test is designed to be simple to use. When combined with a user-provided urine collection cup and a Visby power adapter accessory, the test contains all the materials required to perform the test. The patient collects a first catch urine sample in a standard urine collection cup (not provided). The operator starts the test by using a provided fixed-volume disposable transfer pipette to transfer ~ 450 µL of urine from the collection cup into a dropper tube containing ~900 µL of Visby Medical Men's Sexual Health Buffer. The operator transfers the entire volume (~1.35 mL) of the sample (urine in buffer) into the sample port of the device by squeezing the dropper tube to release all of the sample into the device sample port. The operator then slides a purple switch on the front of the device to both close the sample port and initiate the fully automated testing process. At this point, blinking white lights on the front of the device indicate the test is in progress. Test results are available in just under 30 minutes at which time a green "READY" status light will appear at the bottom of the device, and a purple color will appear in the "RESULTS VALID" spot, indicating a valid test. A purple spot adjacent to "CHLAMYDIA" and/or "GONORRHEA" signifies the presence of amplified CT and/or NG DNA in the sample.
N/A
U.S. Food & Drug Administration FDA Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
October 01, 2025
Visby Medical, Inc.
Jennifer Albrecht
Director of Regulatory Affairs
3010 North 1st Street
San Jose, California 95134
Re: K251501
Trade/Device Name: Visby Medical Men's Sexual Health Test
Regulation Number: 21 CFR 866.3393
Regulation Name: Device To Detect Nucleic Acids From Non-Viral Microorganism(S) Causing Sexually Transmitted Infections And Associated Resistance Marker(S)
Regulatory Class: Class II
Product Code: QEP
Dated: May 9, 2025
Received: May 15, 2025
Dear Jennifer Albrecht:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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K251501 - Jennifer Albrecht Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K251501 - Jennifer Albrecht Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Himani Bisht -S
Himani Bisht, Ph.D.
Assistant Director
Viral Respiratory and HPV Branch
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251501
Device Name: Visby Medical Men's Sexual Health Test
Indications for Use (Describe):
The Visby Medical Men's Sexual Health Test is a single-use (disposable), fully integrated, automated Polymerase Chain Reaction (PCR) in vitro diagnostic test for the rapid detection and differentiation of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae in male urine specimens. The test results are to aid in the diagnosis of symptomatic or asymptomatic infections with Chlamydia trachomatis and Neisseria gonorrhoeae in males.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
Visby Medical Men's Sexual Health Test 510(k) Summary
A. Submitter
Name: Visby Medical, Inc.
Address: 3010 N. First Street
San Jose, CA 95134
Phone: 1-833-468-4729
Contact: Jennifer Albrecht
Date Prepared: May 15, 2025
B. Device
Name of Device: Visby Medical Men's Sexual Health Test
Common Name: Visby Men's Sexual Health Test
Classification Name: Nucleic Acid Detection System for Non-Viral Microorganism(s) Causing Sexually Transmitted Infections
Regulatory Classification: Class II
Regulation: 21 CFR 866.3393
Primary Product Code: QEP
C. Predicate Device
Visby Medical Sexual Health Test (K220407)
D. Device Description
The Visby Medical Men's Sexual Health Test is a single-use (disposable), fully automated, rapid, compact device that contains PCR assays for qualitative detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) DNA in male urine samples from symptomatic or asymptomatic individuals. The device automatically performs all steps required to complete lysis, PCR amplification, and detection.
The Visby Medical Men's Sexual Health Test is designed to be simple to use. When combined with a user-provided urine collection cup and a Visby power adapter accessory, the test contains all the materials required to perform the test. The patient collects a first catch urine sample in a standard urine collection cup (not provided). The operator starts the test by using a provided fixed-volume disposable transfer pipette to transfer ~ 450 µL of urine from the collection cup into a dropper tube containing ~900 µL of Visby Medical Men's Sexual Health Buffer. The operator transfers the entire volume (~1.35 mL) of the sample (urine in buffer) into the sample port of the device by squeezing the dropper tube to release all of the sample into the device sample port. The operator then slides a purple switch on the front of the device to both close the sample port and initiate the fully automated testing process. At this point, blinking white lights on
Page 6
the front of the device indicate the test is in progress. Test results are available in just under 30 minutes at which time a green "READY" status light will appear at the bottom of the device, and a purple color will appear in the "RESULTS VALID" spot, indicating a valid test. A purple spot adjacent to "CHLAMYDIA" and/or "GONORRHEA" signifies the presence of amplified CT and/or NG DNA in the sample.
E. Intended Use
The Visby Medical Men's Sexual Health Test is a single-use (disposable), fully integrated, automated Polymerase Chain Reaction (PCR) in vitro diagnostic test for the rapid detection and differentiation of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae in male urine specimens. The test results are to aid in the diagnosis of symptomatic or asymptomatic infections with Chlamydia trachomatis and Neisseria gonorrhoeae in males.
F. Substantial Equivalence
The Visby Medical Men's Sexual Health Test is substantially equivalent to the Visby Medical Sexual Health Test, K220407.
The following table compares the Visby Medical Men's Sexual Health Test to the Visby Medical Sexual Health Test and outlines the similarities and differences between the two tests.
| Characteristic | Predicate Device: Visby Medical Sexual Health Test | Subject Device: Visby Medical Men's Sexual Health Test |
|---|---|---|
| 510(k) Number | K220407 | N/A |
| Regulation | 21 CFR 866.3393 | Same |
| Product Code | QEP | Same |
| Device Class | Class II | Same |
| Technology/Detection | Nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections | Same |
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| Characteristic | Predicate Device: Visby Medical Sexual Health Test | Subject Device: Visby Medical Men's Sexual Health Test |
|---|---|---|
| Intended Use | The Visby Medical Sexual Health Test is a single-use (disposable), fully integrated, automated Polymerase Chain Reaction (PCR) in vitro diagnostic test intended for use in point-of-care or clinical laboratory settings for the rapid detection and differentiation of DNA from Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in self-collected female vaginal swab specimens using the Visby Medical Sexual Health Vaginal Specimen Collection Kit in a health care setting. The test results are to aid in the diagnosis of symptomatic or asymptomatic infections with Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. | The Visby Medical Men's Sexual Health Test is a single-use (disposable), fully integrated, automated Polymerase Chain Reaction (PCR) in vitro diagnostic test intended for the rapid detection and differentiation of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae in male urine specimens. The test results are to aid in the diagnosis of symptomatic or asymptomatic infections with Chlamydia trachomatis and Neisseria gonorrhoeae in males. |
| Indication for Use | Symptomatic and asymptomatic patients; Rx - For Prescription Use Only | Same |
| Sample to answer system | Automated | Same |
| Specimen Types | Patient-collected vaginal swab in Visby Collection Media | Patient-collected male urine |
| Organisms Detected | Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) | Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) |
| Collection Kit | Swab collection kit | Urine cup (not provided) |
| Sample Extraction | Self-contained and automated after vaginal swab elution into collection media | Self-contained and automated after urine sample dilution into buffer |
| Assay Results | Qualitative | Same |
| Instrument System | N/A, self-contained assay and instrument system | Same |
| Assay Controls | Internal processing control (IPC), External controls available. | Same |
| Turn-around Time | Approximately 30 minutes to results. | Same |
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G. Summary of Performance Data
Clinical Evaluation
Performance characteristics of the Visby Medical Men's Sexual Health Test were established in a clinical study that included testing of prospectively collected fresh specimens. The objective of the study was to establish the clinical performance of the Visby Medical Men's Sexual Health Test for the detection and differentiation of chlamydia (Chlamydia trachomatis [CT]) and gonorrhea (Neisseria gonorrhoeae [NG]) in patient collected urine samples tested by untrained users in point of care settings. This study was conducted at seven POC sites in CLIA Waived testing settings in the US. All study specimens were tested with the Visby Medical Men's Sexual Health Test by typical CLIA Waived operators according to the Quick Reference Guide (QRG) and Instructions for Use (IFU). Specimens were collected and tested between October 2024 and March 2025.
Prospective Sample Testing
Male subjects ≥14 years of age who were symptomatic or asymptomatic for sexually transmitted infections (STIs) were prospectively enrolled at seven clinical study site representative of CLIA waived testing facilities in the US. The collected urine samples were provided to participating study operators who tested them on-site with the Visby device. The remaining urine sample was sent to two reference laboratories for comparator testing with three FDA cleared nucleic acid amplification tests (NAATs) detecting CT and NG.
A total of 1289 subjects were enrolled in the study. Seventeen (17) study specimens were excluded from the performance evaluation due to procedural errors by site study staff or incomplete study procedures (n=8), withdrawal of consent (n=4), lack of a valid Visby test result (n=3), or for the subject not meeting inclusion criteria (n=2). A total of 1272 males (310 symptomatic and 962 asymptomatic) were included in the performance evaluation. Among the 1276 tests performed on the Visby Test, 55 had an invalid result on the first test (4.3%). After a single retest was performed on these 55 specimens, 52 provided a valid result, for a final invalid rate of 0.2% (3/1276).
The sensitivity and specificity of CT and NG are shown in Table 1 below.
Table 1. Prospective Fresh Male Urine Specimen Performance – Enrollment from October 2024 to March 2025 (Visby vs. Comparator Assays)
| Target | N | TP | FP | TN | FN | Sensitivity (95% CI) | Specificity (95% CI) |
|---|---|---|---|---|---|---|---|
| CT | 1272 | 145 | 8 | 1112 | 7 | 95.4% (90.8%-97.8%) | 99.3% (98.6%-99.6%) |
| NG | 1272 | 55 | 8 | 1209 | 0 | 100.0% (93.5%-100.0%) | 99.3% (98.7%-99.7%) |
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Reproducibility
A study was performed to evaluate the reproducibility of the Visby Medical Men's Sexual Health Test when used by untrained users in CLIA Waived settings. The operators performing the testing were non-laboratorians representing healthcare professionals that may be encountered at such sites. The study evaluated five (5) panel members that were prepared using cultured organisms in pooled urine (previously determined to be negative for CT and NG). The study was performed with negative (unspiked), low positive (1x LoD), and moderate positive (3-5x LoD) samples.
A total of six (6) study operators (2 operators at each site) tested the panel three (3) times each testing day, over six (6) non-consecutive days. Three device lots were used in the study. A summary of the results (count correct / total count) and % agreement with expected results for each panel member by site and overall is presented in the table below. The Visby Test demonstrated that untrained users perform testing accurately and reproducibly.
Table 2. Summary of Reproducibility Results with the Visby Medical Men's Sexual Health Test
| Panel Member | Site 1 % Agreement (count) | Site 2 % Agreement (count) | Site 3 % Agreement (count) | Overall Agreement % Agreement (count) | 95% CI |
|---|---|---|---|---|---|
| Moderate Positive CT | 100.0% (36/36) | 100.0% (36/36) | 100.0% (36/36) | 100.0% (108/108) | 96.6%-100.0% |
| Low Positive CT | 97.2% (35/36) | 97.2% (35/36) | 100.0% (36/36) | 98.1% (106/108) | 93.5%-99.5% |
| Moderate Positive NG | 100.0% (36/36) | 100.0% (36/36) | 100.0% (36/36) | 100.0% (108/108) | 96.6%-100.0% |
| Low Positive NG | 100.0% (36/36)ᵃ | 100.0% (36/36) | 100.0% (36/36) | 100.0% (108/108) | 96.6%-100.0% |
| Negative | 100.0% (36/36) | 100.0% (36/36) | 100.0% (36/36) | 100.0% (108/108) | 96.6%-100.0% |
ᵃ One test was unexpectedly positive for CT.
Analytical Evaluation
Limit of Detection
The limit of detection (LoD) is the lowest concentration of pathogen that is reliably detected by the Visby Medical Men's Sexual Health Test. The LoD of the Visby Men's Sexual Health Test was determined for CT in elementary bodies per mL (EB/mL) and NG in colony forming units per mL (cfu/mL), from two distinct strains or serovars, spiked into negative urine in single-positive samples. LoD is defined as the lowest concentration per sample that can be detected 95% of the time. The LoD values for each strain were estimated by probit analysis of the results from a range-finding study of five different concentrations in replicates of 10 per concentration. The calculated LoDs were
Page 10
confirmed by testing 20 replicates and demonstrating that at least 19 out of 20 replicates were positive. The LoD of the Visby Medical Men's Sexual Health Test for each organism are summarized in Table 3 below.
Table 3. Limit of Detection (LoD) for the Visby Medical Men's Sexual Health Test
| Organism | LoD |
|---|---|
| CT Serovar H (ATCC VR-879) | 14.0 EB/mL |
| CT Serovar D (ATCC VR-885) | 32.5 EB/mL |
| NG (ATCC 19424) | 32.0 cfu/mL |
| NG (ATCC 49226) | 2.5 cfu/mL |
Inclusivity
The ability of the Visby Medical Men's Sexual Health Test to detect bacterial strains that represent the clinical and genetic diversity of the target organisms was evaluated by testing 14 serovars of CT and 30 strains of NG near the LoD. Each organism was individually spiked into negative urine at 3x LoD and tested in 3 replicates. If any strain did not result in 3/3 positive results, then the next lower dilution was tested until it was detected in 3/3 replicates. All 14 CT serovars and 30 NG strains were successfully detected at the following concentrations:
Table 4. Analytical Reactivity (Inclusivity) of the Visby Medical Men's Sexual Health Test for CT
| ATCC Number | Serovar | CT Concentration Tested |
|---|---|---|
| VR-571B | A | 97.5 EB/mL |
| VR-573 | B | 97.5 EB/mL |
| VR-347 | Ba | 97.5 EB/mL |
| VR-1500 | C | 97.5 EB/mL |
| VR-348B | E | 97.5 EB/mL |
| nvCT, Swedish variant | E | 97.5 EB/mL |
| VR-346 | F | 97.5 EB/mL |
| VR-878 | G | 97.5 EB/mL |
| VR-880 | I | 97.5 EB/mL |
| VR-886 | J | 97.5 EB/mL |
| VR-887 | K | 97.5 EB/mL |
| VR-901B | LGV I | 97.5 EB/mL |
| VR-902B | LGV II | 195.0 EB/mL |
| VR-903 | LGV III | 97.5 EB/mL |
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Table 5. Analytical Reactivity (Inclusivity) of the Visby Medical Men's Sexual Health Test for NG
| ATCC Number | NG Concentration Tested | ATCC Number | NG Concentration Tested |
|---|---|---|---|
| BAA-1833 | 96.0 cfu/mL | 27632 | 96.0 cfu/mL |
| BAA-1839 | 96.0 cfu/mL | 27633 | 96.0 cfu/mL |
| BAA-1847 | 96.0 cfu/mL | 31148 | 96.0 cfu/mL |
| 9826 | 96.0 cfu/mL | 31149 | 96.0 cfu/mL |
| 9827 | 96.0 cfu/mL | 31151 | 96.0 cfu/mL |
| 9830 | 96.0 cfu/mL | 31356 | 96.0 cfu/mL |
| 10874 | 96.0 cfu/mL | 31397 | 96.0 cfu/mL |
| 11688 | 96.0 cfu/mL | 31398 | 96.0 cfu/mL |
| 11689 | 96.0 cfu/mL | 31401 | 96.0 cfu/mL |
| 19088 | 96.0 cfu/mL | 31402 | 96.0 cfu/mL |
| 23050 | 96.0 cfu/mL | 31403 | 96.0 cfu/mL |
| 23051 | 96.0 cfu/mL | 31406 | 96.0 cfu/mL |
| 27628 | 96.0 cfu/mL | 35541 | 96.0 cfu/mL |
| 27629 | 96.0 cfu/mL | 43069 | 96.0 cfu/mL |
| 27631 | 96.0 cfu/mL | 49981 | 96.0 cfu/mL |
Cross-Reactivity and Microbial Interference
The potential for cross reactivity from microorganisms that may be found in urine other than the target pathogens (CT and NG) on the performance of the Visby Medical Men's Sexual Health Test was evaluated. Eighty-three (83) microorganisms were tested in triplicate at high concentrations (≥10⁵ units/mL for viruses and ≥10⁶ units/mL for bacteria, protozoa, and yeast) in negative samples (urine). A single false positive CT result (out of 3 replicates) was observed with inactivated HIV-1 (ZeptoMetrix NATHIV1-LIN) material; negative results were returned in 10/10 tests with live HIV-1 culture fluid.
Additionally, three organisms could not be obtained for direct testing (Bacterial Vaginosis Associated Bacteria 2 (BVAB-2), Megasphaera type 1, and Dientamoeba fragilis). The sequences of these organisms were analyzed against the Visby Men's Sexual Health Test primer and amplicon sequences using basic local alignment search tool (BLAST). No match was found for any of the 3 organisms.
Microbial Interference was evaluated on the Visby Men's Sexual Health Test by testing 11 microorganisms chosen based on the likelihood of their presence in a urine sample or genetic similarities to the target organisms in the presence of low concentrations of the target organisms (3x LoD for CT and NG). No microbial interference was observed with any of the organisms tested. The 11 microorganisms chosen are denoted in the following table by an asterisk.
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*Table 6. Microorganisms Evaluated for Cross-Reactivity and Microbial Interference (denoted by ) on Visby Medical Men's Sexual Health Test
| Microorganism (ATCC Number) | Microorganism (ATCC Number) |
|---|---|
| Acinetobacter lwoffii (15309) | Mobiluncus curtisii (35241) |
| Actinomyces israelii (12102) | Mobiluncus mulieris (35243) |
| Atopobium vaginae (BAA-55) | Mycoplasma genitalium* (49123) |
| Bacteroides fragilis (25285) | Mycoplasma hominis (23114) |
| Bacteroides ureolyticus (33387) | Neisseria cinerea (14685) |
| Bifidobacterium adolescentis (15703) | Neisseria elongata (25295, 29315, 49378) |
| Bifidobacterium longum (15697) | Neisseria flava (14221) |
| BV associated bacteria¹ (BVAB-2, N/A) | Neisseria flavescens (13116, 13120) |
| Campylobacter jejuni (33291) | Neisseria lactamica (23970, 23971, 23972, 49142) |
| Candida albicans* (801504, ZeptoMetrix) | Neisseria meningitidis serogroup a* (13077) |
| Candida glabrata (90030) | Neisseria meningitidis serogroup b (13090) |
| Candida parapsilosis (22019) | Neisseria meningitidis serogroup c (13102) |
| Candida tropicalis (750) | Neisseria meningitidis serogroup D (13113) |
| Chlamydia pneumoniae* (53592) | Neisseria meningitidis serogroup w-135 (35559) |
| Chlamydophila psittaci* (MBC013-R, Vircell) | Neisseria meningitidis serogroup y (35561) |
| Clostridium difficile (9689) | Neisseria mucosa (19695, 25998, 49233) |
| Clostridium perfringens (13124) | Neisseria perflava (14799) |
| Corynebacterium genitalium (33034) | Neisseria polysaccharea (43768) |
| Corynebacterium xerosis (373) | Neisseria sicca (9913, 29193, 29256) |
| Cryptococcus neoformans (66031) | Neisseria subflava (4788) |
| Cutibacterium acnes (6919) | Pentatrichomonas hominis (30000) |
| Dientamoeba fragilis¹ (N/A) | Peptostreptococcus anaerobius (27337) |
| Enterobacter cloacae (13047) | Prevotella bivia (29303) |
| Enterococcus faecalis* (29212) | Proteus mirabilis (7002) |
| Escherichia coli* (25922) | Pseudomonas aeruginosa (0801519, ZeptoMetrix) |
| Fusobacterium nucleatum (25586) | Staphylococcus aureus (12600) |
| Gardnerella vaginalis (14018) | Staphylococcus epidermidis (14990) |
| Haemophilus ducreyi (33940) | Streptococcus agalactiae (13813) |
| Herpes simplex virus I* (VR-539) | Streptococcus pyogenes (19615) |
| Herpes simplex virus II (VR-540) | Trichomonas tenax* (30207) |
| HIV-1* (0801032CF, ZeptoMetrix) | Trichomonas vaginalis* (30001) |
| Human papilloma virus 16 E6/E7 (Transformed cells) (CRL-2616) | Ureaplasma parvum (27815) |
| Kingella dentrificans (33394) | Ureaplasma urealyticum (27618) |
| Klebsiella aerogenes (13048) | |
| Klebsiella oxytoca (49131) | |
| Klebsiella pneumoniae (13883) | |
| Lactobacillus acidophilus (4356) | |
| Lactobacillus brevis (14869) | |
| Lactobacillus jensenii (25258) | |
| Lactobacillus vaginalis (49540) | |
| Lactococcus lactis (19435) | |
| Listeria monocytogenes (19115) | |
| Megashaera type 1¹ (N/A) |
¹ These organisms were not available for direct testing and were evaluated using in-silico analysis
- These organisms were also tested in microbial interference
Page 13
Competitive Interference
The Visby Medical Men's Sexual Health Test was evaluated for performance in the case of a mixed infection (presence of multiple target organisms), where the potential for high concentrations of one target organism to interfere with detection of low concentrations of another target organism was evaluated. Each of the target organisms (CT and NG) were spiked into negative urine at varying concentrations and then tested in triplicate. Low concentrations were prepared at 3x LoD for the respective organisms and high concentrations were prepared at 1 x 10⁶ units/mL. No competitive interference was observed at the levels tested for the two target organisms.
Table 7. Competitive Interference Evaluated on the Visby Medical Men's Sexual Health Test
| Organism and Concentration | CT (# Positive / # Tested) | NG (# Positive / # Tested) |
|---|---|---|
| CT | NG | |
| Low | High | 3/3 |
| Low | Low | 3/3 |
| Low | Neg | 3/3 |
| High | High | 3/3 |
| High | Low | 3/3 |
| High | Neg | 3/3 |
| Neg | High | 0/3 |
| Neg | Low | 0/3 |
| Neg | Neg | 0/3 |
Endogenous/Exogenous Interfering Substances
Potentially interfering substances that may be found in a urine sample were evaluated to determine if they interfere with the accuracy of test results. The potentially interfering substances were diluted in the negative urine and tested in the presence of low concentrations (3x LoD) of CT and NG organisms. The testing was also performed with negative urine samples. All samples were tested in triplicate. As shown in Table 8 below, all the negative and positive samples returned expected results. None of the tested substances were found to interfere with test results.
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Table 8. Potentially Interfering Substances Evaluated on the Visby Medical Men's Sexual Health Test
| Substance | Concentration Tested | Negative Sample (# Expected Results / # Tests) | Positive Sample (# Expected Results / # Tests) |
|---|---|---|---|
| Endogenous Substances: Test substances produced by the body | |||
| Acidic Urine | pH 4 | 3/3 | 3/3 |
| Alkaline Urine | pH 9 | 3/3 | 3/3 |
| Albumin (BSA) | 500 µg/mL | 3/3 | 3/3 |
| Beta Estradiol | 0.07 mg/mL | 3/3 | 3/3 |
| Bilirubin | 100 µg/mL | 3/3 | 3/3 |
| Glucose | 1 mg/mL | 3/3 | 3/3 |
| Leukocytes | 1x10⁶ cells/mL | 3/3 | 3/3 |
| Mucin (Bovine) | 0.80% w/v | 3/3 | 3/3 |
| Progesterone | 0.07 mg/mL | 3/3 | 3/3 |
| Seminal Fluid | 5% v/v | 3/3 | 3/3 |
| Whole Blood | 1% v/v | 3/3 | 3/3 |
| Exogenous Substances: Common prescription and over-the-counter drugs | |||
| Acetaminophen | 2200 µg/mL | 3/3 | 3/3 |
| Amoxicillin Trihydrate | 6900 µg/mL | 3/3 | 3/3 |
| Aspirin | 1200 µg/mL | 3/3 | 3/3 |
| Azithromycin | 2900 µg/mL | 3/3 | 3/3 |
| Biotin | 10 µg/mL | 3/3 | 3/3 |
| Ceftriaxone | 1200 µg/mL | 3/3 | 3/3 |
| Doxycycline | 500 µg/mL | 3/3 | 3/3 |
| Erythromycin | 900 µg/mL | 3/3 | 3/3 |
| Ibuprofen | 1200 µg/mL | 3/3 | 3/3 |
| Metronidazole | 1500 µg/mL | 3/3 | 3/3 |
| Naproxen | 1200 µg/mL | 3/3 | 3/3 |
| Phenazopyridine Hydrochloride | 500 µg/mL | 3/3 | 3/3 |
| Tetracycline Hydrochloride | 1700 µg/mL | 3/3 | 3/3 |
| Trimethoprim | 250 µg/mL | 3/3 | 3/3 |
| Sulfamethoxazole | 1800 µg/mL | 3/3 | 3/3 |
| External Substances: Can be introduced during collection | |||
| Abreva Cold Sore Cream | 0.25% w/v | 3/3 | 3/3 |
| KY Jelly Personal Lubricant | 0.25% w/v | 3/3 | 3/3 |
| Preparation H Hemorrhoidal Ointment | 0.25% w/v | 3/3 | 3/3 |
| Talcum Powder | 0.25% w/v | 3/3 | 3/3 |
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Specimen Stability
The stability of urine specimens was determined when stored at room temperature (30°C) or refrigerated (2 - 8°C) conditions. CT and NG were spiked into negative urine at 2x LoD and tested at baseline and at each storage time-point with 20 replicates. All low positive devices returned the expected double positive results at all time-points tested. Based on the results, the following specimen stability in Visby Men's Sexual Health Buffer is claimed:
- Room temperature (15 – 30°C) storage up to 180 minutes (3 hours)
- Refrigerated (2 – 8°C) storage up to 24 hours
H. Conclusion
The analytical and clinical studies have demonstrated that the Visby Medical Men's Sexual Health Test is substantially equivalent to the predicate device (K220407).
§ 866.3393 Device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s).
(a)
Identification. A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections and associated resistance marker(s) is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) and their associated resistance markers in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data. These devices do not provide confirmation of antibiotic susceptibility since mechanisms of resistance may exist that are not detected by the device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of targets the device detects, the results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens;
(ii) Detailed discussion of the performance characteristics of the device for all claimed specimen types based on analytical studies, including Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate;
(iii) Detailed descriptions of the test procedure, the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing;
(iv) Limiting statements indicating that:
(A) A negative test result does not preclude the possibility of infection;
(B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician;
(C) Reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and
(D) If appropriate (
e.g., recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer reviewed research), that the clinical performance is inferior in a specific clinical subpopulation or for a specific claimed specimen type; and(v) If the device is intended to detect antimicrobial resistance markers, limiting statements, as appropriate, indicating that:
(A) Negative results for claimed resistance markers do not indicate susceptibility of detected microorganisms, as resistance markers not measured by the assay or other potential mechanisms of antibiotic resistance may be present;
(B) Detection of resistance markers cannot be definitively linked to specific microorganisms and the source of a detected resistance marker may be an organism not detected by the assay, including colonizing flora;
(C) Detection of antibiotic resistance markers may not correlate with phenotypic gene expression; and
(D) Therapeutic failure or success cannot be determined based on the assay results, since nucleic acid may persist following appropriate antimicrobial therapy.
(4) Design verification and validation must include:
(i) Detailed device description documentation, including methodology from obtaining sample to result, design of primer/probe sequences, rationale for target sequence selection, and computational path from collected raw data to reported result (
e.g., how collected raw signals are converted into a reported result).(ii) Detailed documentation of analytical studies, including, Limit of Detection, inclusivity, cross-reactivity, microbial interference, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, within lab precision, and reproducibility, as appropriate.
(iii) Detailed documentation and performance results from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, when determined to be appropriate by FDA, additional characterized clinical samples. The study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained from FDA accepted comparator methods. Documentation from the clinical studies must include the clinical study protocol (including a predefined statistical analysis plan) study report, testing results, and results of all statistical analyses.
(iv) A detailed description of the impact of any software, including software applications and hardware-based devices that incorporate software, on the device's functions.