(386 days)
K200748/CW200003
Not Found
No
The description focuses on the automated PCR process and colorimetric detection, with no mention of AI or ML for data analysis or interpretation.
No.
This device is an in vitro diagnostic test intended for diagnosis; it does not provide any therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the test is "intended for use... for the rapid detection and differentiation of DNA from Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in self-collected female vaginal swab specimens... The test results are to aid in the diagnosis of symptomatic infections..." This directly aligns with the definition of a diagnostic device.
No
The device description explicitly states that the test system includes the "Visby Medical Sexual Health device," which is described as a "single-use (disposable), fully integrated, rapid, compact device containing a PCR-based assay." This indicates a physical hardware component, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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..."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for 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 infections with Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.
Product codes
QEP, MKZ, LSL, OUY
Device Description
The Visby Medical Sexual Health Test (Visby Test) is a single-use (disposable), fully integrated, rapid, compact device containing a PCR-based assay for direct qualitative detection and differentiation of DNA from CT, NG, and TV. The test system includes the Visby Medical Sexual Health device, the Visby Medical power supply, the Visby Medical Vaginal Specimen Collection kit, and fixed-volume transfer pipettes. The device processes self-collected vaginal swab samples by automatically performing all steps required to complete lysis, polymerase chain reaction, and amplicon detection.
The patient uses the Visby Medical Vaginal Specimen Collection Kit to self-collect a vaginal specimen with the provided flocked swab, and then the patient elutes the specimen into the Visby Medical Collection Media. The test operator transfers the collection media containing the patient specimen into the sample port of the device using the provided fixed-volume pipette where it rehydrates a lyophilized internal process control. The sample enters a lysis module, where the DNA of the sample and the internal process control are extracted using a combination of chemical lysis and high temperature. The extracted DNA enters a mixing chamber where it rehydrates lyophilized PCR reagents, followed by thermocycling to amplify target DNA. If present, the amplified pathogen target (CT, NG, and/or TV) and internal process control hybridize to specific probes located on a flow channel. Detection of the target-specific PCR product is accomplished via an enzyme-linked colorimetric assay using streptavidin bound horseradish peroxidase (HRP) and a colorimetric substrate that forms a purple precipitate. Test results can be expected in approximately 30 minutes: a green check mark will appear, and a purple color will appear in the "Results Valid" spot, indicating a valid test. A purple spot adjacent to "Chlamydia," "Gonorrhea," and/or "Trichomoniasis" signifies the presence of amplified CT, NG, and/or TV DNA in the sample.
Vaginal self-collection kits containing a tube of collection media compatible with the Sexual Health test and a collection swab are also packaged separately. External controls recommended in the product labeling are commercially available from a different manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
female vaginal swab specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
point-of-care or clinical laboratory settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of Limit of Detection between the Visby Test and Click Test
This study provides objective evidence that the LoD for the Visby Test is comparable to that of the Click Test. Negative pooled clinical vaginal sample in Visby Collection Media was spiked at the LoD that was established with the Click Test and tested with 20 Visby devices and 20 Click devices. If at least 19/20 devices returned a positive test result, the organism was diluted 3-fold and the testing was repeated until the detection rate was
§ 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.
0
March 7, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Visby Medical Beth Lingenfelter Vice President Regulatory and Clinical Affairs 3010 N 1st Street San Jose, California 95134
Re: K220407
Trade/Device Name: Visby Medical 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, MKZ, LSL, OUY Dated: February 10, 2022 Received: February 14, 2022
Dear Beth Lingenfelter:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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
2
Indications for Use
510(k) Number (if known) K220407
Device Name Visby Medical Sexual Health Test
Indications for Use (Describe)
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 infections with Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.
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) |
|---|---|
| ---------------------------------------------------------------------------------- | ---------------------------------------------------------------------- |
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3
510(k) Summary
A. Submitter
B.
| Name: | Visby Medical, Inc. |
|---|---|
| Address: | 3010 N. First Street |
| San Jose, CA 95134 | |
| Phone: | 1-833-468-4729 |
| Contact: | Beth Lingenfelter |
| Date Prepared: | January 20, 2023 |
| Device | |
| Name of Device: | Visby Medical Sexual Health Test |
| Common Name: | Same |
| Classification Name: | Device to Detect Nucleic Acids from Non-Viral |
| Microorganism(s) Causing Sexually Transmitted Infections | |
| and Associated Resistance Marker(s) | |
| Regulatory Classification: | Class II |
| Regulation: | 21 CFR 866.3393 |
| Primary Product Code: | QEP |
| Additional Product Codes: | MKZ, LSI, and QUY |
C. Predicate Device
Visby Medical Sexual Health Click Test (K200748/CW200003)
D. Device Description
The Visby Medical Sexual Health Test (Visby Test) is a single-use (disposable), fully integrated, rapid, compact device containing a PCR-based assay for direct qualitative detection and differentiation of DNA from CT, NG, and TV. The test system includes the Visby Medical Sexual Health device, the Visby Medical power supply, the Visby Medical Vaginal Specimen Collection kit, and fixed-volume transfer pipettes. The device processes self-collected vaginal swab samples by automatically performing all steps required to complete lysis, polymerase chain reaction, and amplicon detection.
The patient uses the Visby Medical Vaginal Specimen Collection Kit to self-collect a vaginal specimen with the provided flocked swab, and then the patient elutes the specimen into the Visby Medical Collection Media. The test operator transfers the collection media containing the patient specimen into the sample port of the device using the provided fixed-volume pipette where it rehydrates a lyophilized internal process
4
control. The sample enters a lysis module, where the DNA of the sample and the internal process control are extracted using a combination of chemical lysis and high temperature. The extracted DNA enters a mixing chamber where it rehydrates lyophilized PCR reagents, followed by thermocycling to amplify target DNA. If present, the amplified pathogen target (CT, NG, and/or TV) and internal process control hybridize to specific probes located on a flow channel. Detection of the target-specific PCR product is accomplished via an enzyme-linked colorimetric assay using streptavidin bound horseradish peroxidase (HRP) and a colorimetric substrate that forms a purple precipitate. Test results can be expected in approximately 30 minutes: a green check mark will appear, and a purple color will appear in the "Results Valid" spot, indicating a valid test. A purple spot adjacent to "Chlamydia," "Gonorrhea," and/or "Trichomoniasis" signifies the presence of amplified CT, NG, and/or TV DNA in the sample.
Vaginal self-collection kits containing a tube of collection media compatible with the Sexual Health test and a collection swab are also packaged separately. External controls recommended in the product labeling are commercially available from a different manufacturer.
E. 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 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.
F. Substantial Equivalence
The Visby Test is an updated version of the Visby Medical Sexual Health Click test (Click Test, the predicate). The Visby Test has no changes to the PCR primer and probe sequences, reagent formulations, detection method, or result interpretations.
Both devices have a similar design and are composed of the same materials. The Visby Test was developed to further simplify the user interface and to enable the automated manufacture process of the device,
The following table compares the Visby Test to the Click Test and outlines the similarities between the two tests.
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| Characteristics | Predicate
Click Test | Subject Device
Visby Test | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Principle of
Operation | An automated multiplex polymerase
chain reaction with colorimetric
detection. | Same | |
| Analyte | DNA | Same | |
| Organisms
Detected | Chlamydia trachomatis (CT)
Neisseria gonorrhoeae (NG)
Trichomonas vaginalis (TV) | Same | |
| Patient
Population | Asymptomatic and symptomatic female
patients | Same | |
| Intended Use | The Visby Medical Sexual Health
Click 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
collected using 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. | Same, only change is to the name of the
device.
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 collected using 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. | |
| Specimen Type | Patient-collected vaginal swab in Visby
Collection Media | Same | |
| CLIA Complexity
Level | CLIA waived | Same | |
| Quality Control | Internal electronic and process controls
External Controls (by Zeptometrix) | Same | |
| Characteristics | Predicate
Click Test | Subject Device
Visby Test | |
| Reagents | Target specific primers
Target specific capture probes
Lyophilized PCR reagent
Enzyme linked colorimetric reagents of
visualization of target amplicon | Same | |
| | Results
interpretation | Operator visually interprets test results | Same |
| | Time to result | Approximately 30 minutes | Same |
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G. Summary of Performance Data
Comparison of Limit of Detection between the Visby Test and Click Test
This study provides objective evidence that the LoD for the Visby Test is comparable to that of the Click Test. Negative pooled clinical vaginal sample in Visby Collection Media was spiked at the LoD that was established with the Click Test and tested with 20 Visby devices and 20 Click devices. If at least 19/20 devices returned a positive test result, the organism was diluted 3-fold and the testing was repeated until the detection rate was