(239 days)
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No
The device description and performance studies focus on the microbiological growth medium and transport capabilities, with no mention of AI or ML for analysis or interpretation.
No
The device is a microbiological device intended to differentiate and support the growth of Neisseria gonorrhoeae, which is a diagnostic function, not a therapeutic one.
Yes
The InTray GC is a microbiological device intended to differentiate and support the growth of pathogenic Neisseria gonorrhoeae, which is a diagnostic purpose.
No
The device description clearly outlines a physical, hardware-based microbiological device consisting of a sealed well, agar medium, a CO2 generating tablet, and an outer seal. There is no mention of software as a component or the primary function of the device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to differentiate and support the growth of pathogenic Neisseria gonorrhoeae". This is a diagnostic purpose, aiming to identify the presence of a specific pathogen in a patient sample.
- Sample Type: The device is used with "inoculated samples" and "patient sample", indicating it is used to test biological specimens taken from a human.
- Method: The device utilizes a microbiological culture medium to grow and identify the target organism. This is a common method used in in vitro diagnostics.
- Performance Studies: The document describes performance studies that evaluate the device's ability to recover and grow the target organism, which is a key aspect of demonstrating the diagnostic performance of an IVD.
The definition of an IVD generally includes devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The InTray GC is a microbiological device intended to differentiate and support the growth of pathogenic Neisseria gonorrhoeae when incubated at 35°C for 24-72 hours. Inoculated samples can optionally be pre-incubated prior to transport when pre-incubated at 35°C for 24 hours. Subsequent transport, of the pre-incubated specimen under controlled room temperature (18 to 25°C), is supported out to 72 hours.
Product codes (comma separated list FDA assigned to the subject device)
JTY
Device Description
The InTray GC is a Modified Thayer-Martin medium within a sealed inner well. The inner seal covers the inner well containing agar and an additional sealed cavity containing a CO2 generating tablet. There is also an outer adhesive label seal with a window that does not fog up under 100% relative humidity. The user opens and inoculates the surface of the medium with the patient sample followed by resealing the outer adhesive label. High humidity within the InTray causes the tablet to generate CO2 thus providing adequate bacterial growth condition for the target pathogen. After incubation of the inoculated InTray, the bacterial growth can be observed through the window without opening the InTray and therefore not disturbing the established CO2 concentration. Observation of culture growth can be by eye, hand lens or microscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Four InTray replicates were inoculated with approximately 20 colony forming units (CFU) for each experimental group and the process was repeated with the five different AR isolate bank strains (N. gonorrhoeae strains 0165, 0202, 0175, 0181 & 0197) and N. gonorrhoeae strain ATCC 43069. One lot of InTray GC transport device was used in the study.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Transport simulation study and comparative assessment study.
Sample Size:
- Transport simulation study: Four InTray replicates per experimental group, repeated with 6 different N. gonorrhoeae strains.
- Comparative assessment study: Multiple lots of InTray GC devices (3 lots testing 5 strains (N=15 replicates) and two different lots testing one of the six strains (N=2 replicates)). Three replicates of a legally marketed transport device for 6 N. gonorrhoeae strains.
Standalone Performance: The data from the transport simulation study showed that inoculated samples pre-incubated at 35℃ for 24 hours followed by transport at 18-25℃ for 72 hours, demonstrated recovery via increased colony size when compared to samples that were not pre-incubated.
Key Results: The results of the comparative assessment study showed that there was ≤2 log10 CFU/mL difference in N. gonorrhoeae recovery, for each strain, between time zero (no transport) and the experimental endpoint (72-hour transport) for the InTray GC device. There was no difference between the performance of the predicate device and transported InTray GC device. Acceptable recovery performance was also achieved for the legally marketed transport device when time zero and the experimental endpoint of 24 hours were compared, demonstrating that sufficient viability of N. gonorrhoeae was achieved using traditional transport and culture techniques. The results also substantiate that the InTray GC device may be used for transport when following the new procedure. Cross reactivity testing was previously captured in the original 510K (K993033).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
A decline in the CFU/mL of ≤2 log10 between time zero and the end of the experimental incubation was considered acceptable.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.2410 Culture medium for pathogenic
Neisseria spp.(a)
Identification. A culture medium for pathogenicNeisseria spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenicNeisseria spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo features the Department of Health & Human Services seal on the left. To the right of the seal is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 20, 2021
Biomed Diagnostics Incorporated John Antiabong Research and Development Director 1388 Antelope Road White City, Oregon 97503
Re: K210511
Trade/Device Name: InTray GC Regulation Number: 21 CFR 866.2410 Regulation Name: Culture Media for Pathogenic Neisseria Spp. Regulatory Class: Class II Product Code: JTY Dated: February 23, 2021 Received: February 23, 2021
Dear John Antiabong:
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 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
1
- 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 (QS) 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 medical devices and radiation-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.
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Indications for Use (Describe)
| 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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510(k) Summary
February 12, 2021
510(k) Owner: Biomed Diagnostics, Inc. (Registration number 2951280)
1388 Antelope Rd
White City, OR 97503
Phone: 541-8303000
Fax: 541-8303001
Contact person: Dr. John F Antiabong
Director Research and Development
BIOMED DIAGNOSTICS INC.
1388 Antelope Rd
White City, OR 97503
Phone: 541-8303000-1040
Email: jantiabong@biomeddiagnostics.com
Device
Trade name: InTray® GC
Common name: Culture Medium For Pathogenic Neisseria Spp
Classification name: Culture medium for pathogenic Neisseria spp Class II, 21 CFR 866.2410, (Device product code: JTY).
Predicate device
InTray GC, 510K# K993033 cleared in 1999
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Image /page/4/Picture/0 description: The image shows the logo for BioMed Diagnostics. The logo has the words "BIO MED" in large, bold, black letters on the top line. Below that, the word "DIAGNOSTICS" is written in smaller, blue letters. To the left of the words, there is a blue crescent shape that curves upwards and around the left side of the words.
Device description
The InTray GC is a Modified Thayer-Martin medium within a sealed inner well. The inner seal covers the inner well containing agar and an additional sealed cavity containing a CO2 generating tablet. There is also an outer adhesive label seal with a window that does not fog up under 100% relative humidity. The user opens and inoculates the surface of the medium with the patient sample followed by resealing the outer adhesive label. High humidity within the InTray causes the tablet to generate CO2 thus providing adequate bacterial growth condition for the target pathogen. After incubation of the inoculated InTray, the bacterial growth can be observed through the window without opening the InTray and therefore not disturbing the established CO2 concentration. Observation of culture growth can be by eye, hand lens or microscope.
Intended Use
The InTray GC is a microbiological device intended to differentiate and support the growth of pathogenic Neisseria gonorrhoeae when incubated at 35°C for 24-72 hours. Inoculated samples can optionally be pre-incubated prior to transport when pre-incubated at 35°C for 24 hours. Subsequent transport, of the pre-incubated specimen under controlled room temperature (18 to 25°C), is supported out to 72 hours.
Substantial equivalence
The InTray GC (K210511) is substantially equivalent to the current legally marketed InTray GC (K993033). The InTray GC support the growth of pathogenic Neisseria gonorrhoeae. Both devices utilize the same technology by supporting N. gonorrhoeae on Modified Thayer-Martin medium. A transport simulation study as well as a comparative assessment study, using the InTray GC device, were conducted to determine the performance characteristics of InTray GC and to validate the new transportation claim. The study results showed that the InTray GC is acceptable for its intended use and is substantially equivalent to the predicate device. The table below shows the similarities and differences between the InTray GC and the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for BioMed Diagnostics. The logo has the words "BIO MED" in bold, black letters on the top line. Below that, the word "DIAGNOSTICS" is in smaller, blue letters. A blue crescent shape is on the left side of the logo, arching over the words "BIO MED".
| SIMILARITIES | ||
|---|---|---|
| Descriptive Category | Subject Device: InTray GC | |
| Transport Function | Predicate Device: InTray GC | |
| (K993033) | ||
| Indications for use | The InTray GC is a | |
| microbiological device intended | ||
| to differentiate and support the | ||
| growth of pathogenic Neisseria | ||
| gonorrhoeae when incubated at | ||
| 35°C for 24-72 hours. Inoculated | ||
| samples can optionally be pre- | ||
| incubated prior to transport when | ||
| pre-incubated at 35°C for 24 | ||
| hours. Subsequent transport, of | ||
| the pre-incubated specimen under | ||
| controlled room temperature (18 | ||
| to 25°C), is supported out to 72 | ||
| hours. | InTray GC is used, like conventional | |
| Thayer-Martin media plates, to grow | ||
| Neisseria gonorrhoeae and similar | ||
| organisms. | ||
| Device Product Code | JTY | Same |
| Prescription/over-the- | ||
| counter use | Rx Only | Same |
| Collection apparatus | Does not include a specimen | |
| collection swab | Same | |
| Reagents | Modified Thayer Martin medium | |
| (agar) | Same | |
| Specimen type | Only sample intended for growth | |
| of Neisseria species | Same | |
| Shelf-life | 12 months | Same |
| DIFFERENCES | ||
| Descriptive Category | Subject Device: InTray GC | |
| Transport Function | Predicate Device: InTray GC | |
| (K933033) | ||
| Transport claim | Transport at 18-25°C for up to 72 | |
| hours | No transport |
1388 Antelope Road | White City, OR 97503, USA | 541.830.3000 | f 541.830.3001
biomeddiagnostics.com biomeddiagnostics.com
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Image /page/6/Picture/0 description: The image shows the logo for Bio Med Diagnostics. The logo has the words "BIO MED" in bold, black letters on the top line. Below that, the word "DIAGNOSTICS" is in a smaller, lighter blue font. A blue curved line starts at the bottom left of the logo and extends upwards and over the top of the words "BIO MED".
Non-clinical performance data
To demonstrate substantial equivalence of the InTray GC (K210511) to the previously cleared InTray GC (K993033) as a predicate device, Biomed Diagnostics Inc. performed data analysis on the recoverability of the N. gonorrhoeae after sample inoculation, transport simulation and incubation of both devices according to manufacturer's specifications. First, to determine the optimal specimen transport condition that ensures recovery of viable N. gonorrhoeae in the InTray GC, various transport conditions that simulated potential conditions in the healthcare operations were evaluated to determine the clinical utility of the InTray GC as a specimen transport device from site of collection to the laboratory. Four InTray replicates were inoculated with approximately 20 colony forming units (CFU) for each experimental group outlined in the table below and the process was repeated with the five different AR isolate bank strains (N. gonorrhoeae strains 0165, 0202, 0175, 0181 & 0197) and N. gonorrhoeae strain ATCC 43069. One lot of InTray GC transport device was used in the study.
Experimental groups
| Experimental
Group | Experimental Treatment Post Inoculation with 20 CFU N.
gonorrhoeae | | |
|-----------------------|-------------------------------------------------------------------------------------|-------------------------|-------------------------------|
| | Pre-incubate: | Store: | Incubate*: |
| Group A | At 35°C for 24 hours | At 18-25°C for 72 hours | At 35°C for at least 72 hours |
| Group B | At 35°C for 24 hours | None | At 35°C for at least 72 hours |
| Group C1 | No pre-incubation | At 18-25°C for 24 hours | At 35°C for at least 72 hours |
| Group C2 | No pre-incubation | At 18-25°C for 48 hours | At 35°C for at least 72 hours |
| Group C3 | No pre-incubation | At 18-25°C for 72 hours | At 35°C for at least 72 hours |
- Also, continuous observation for up to 144 hours.
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Image /page/7/Picture/0 description: The image shows the logo for BioMed Diagnostics. The logo has the words "BIO MED" in bold, black letters on the top line. Below that, the word "DIAGNOSTICS" is in smaller, blue letters. A blue crescent shape is on the left side of the logo, curving from the top to the bottom.
The data from the transport simulation study showed that inoculated samples pre-incubated at 35℃ for 24 hours followed by transport at 18-25℃ for 72 hours, demonstrated recovery via increased colony size when compared to samples that were not pre-incubated.
InTray GC transport and recovery was also compared to recovery using a legally marketed transport device and six N. gonorrhoeae strains. Multiple lots of variously aged InTray GC devices were used to test the six strains of N. gonorrhoeae, with 3 lots testing 5 strains (N=15 replicates) and two different lots testing one of the six strains (N=2 replicates). InTray GC devices were inoculated with 20 uL of a 1.5x103 CFU/mL in 0.85% saline of each N. gonorrhoeae strain. Group B experimental design was used to establish time zero of incubation and Group A experimental design was used to evaluate the 72-hour transport claim - schematic in the Table above.
Three replicates of the legally marketed transport device were used to inoculate the same six N. gonorrhoeae strains, as those used for the InTray GC device, at an inoculum of 1.5x107 CFU/mL in 0.85% saline. The legally marketed transport device was incubated at room temperature for 24-hours. Chocolate agar culture media was used for the determination of the organism recovery and for enumeration of the colony forming units recovered. The differences in inoculum concentration between InTray and the legally marketed transport device are to account for the 24-hour pre-incubation step and size of InTray GC device.
A decline in the CFU/mL of ≤2 log10 between time zero and the end of the experimental incubation was considered acceptable. The results of the comparative assessment study showed that there was ≤2 log10 CFU/mL difference in N. gonorrhoeae recovery, for each strain, between time zero (no transport) and the experimental endpoint (72-hour transport) for the InTray GC device. There was no difference between the performance of the predicate device and transported InTray GC device. Acceptable recovery performance was also achieved for the legally marketed transport device when time zero and the experimental endpoint of 24 hours were compared, demonstrating that sufficient viability of N. gonorrhoede was achieved using traditional transport and culture techniques. The results also substantiate that the InTray GC device may be used for transport when following the new procedure.
Cross reactivity testing of the InTray GC device is already captured in the original 510K (K993033) and also presented in the instruction for use (IFU) document.
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Image /page/8/Picture/0 description: The image shows the logo for BioMed Diagnostics. The logo has the words "BIO MED" in large, bold, black letters. Below the words "BIO MED" is the word "DIAGNOSTICS" in smaller, blue letters. To the left of the words "BIO MED" is a blue crescent shape.
Conclusion
These performance characteristics therefore show that the InTray GC (K210511) is substantially equivalent to the previously cleared InTray GC (K993033) as an IVD for the transport of inoculated sample/specimen and subsequent recovery of N. gonorrhoeae in the laboratory.