INTRAY GC

K993033 · Biomed Diagnostics, Inc. · JTY · Dec 16, 1999 · Microbiology

Device Facts

• Record ID: K993033
• Device Name: INTRAY GC
• Applicant: Biomed Diagnostics, Inc.
• Product Code: JTY · Microbiology
• Decision Date: Dec 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2410
• Device Class: Class 2

Indications for Use

InTray GC is used, like conventional Thayer-Martin media plates, to grow Neisseria gonomhoeae and similar organisms.

Device Story

InTray GC is a self-contained diagnostic packaging system for Modified Thayer-Martin (MTM) culture media. It consists of a sealed inner well containing 5-6ml of MTM media and a separate sealed cavity containing a CO2-generating tablet. The user inoculates the medium with a patient sample, punctures the CO2 cavity seal, and reseals the outer label. High humidity within the tray activates the tablet to generate a CO2-enriched atmosphere. The device allows for incubation and observation of organism growth through a fog-resistant window without opening the tray, maintaining the internal atmosphere. It is used in clinical laboratory settings to facilitate the isolation of pathogenic Neisseria. Observation is performed via eye, hand lens, or microscope. The system provides a shelf-stable alternative to traditional culture plates, offering improved suppression of contaminants like C. albicans.

Clinical Evidence

Clinical study performed with 228 female patients using cervical swabs. Results for N. gonorrhoeae detection were identical to commercially prepared media (18 positive, 210 negative). The device showed superior suppression of C. albicans (17 positive vs 30 positive in comparison media). Laboratory bench testing using pure cultures of four N. gonorrhoeae strains and various contaminants (N. sicca, E. coli, S. epidermidis, P. mirabilis, C. albicans) demonstrated successful recovery of organisms and superior contaminant suppression after one year of room temperature storage.

Technological Characteristics

InTray GC utilizes Modified Thayer-Martin (MTM) culture medium. The device features a two-inch diameter well, a CO2-generating tablet, and a fog-resistant adhesive label seal. It is a standalone, non-electronic diagnostic device. Sterilization and specific material standards are not detailed.

Indications for Use

Indicated for the isolation and growth of Neisseria gonorrhoeae and similar organisms from clinical samples. Intended for prescription use.

Regulatory Classification

Identification

A culture medium for pathogenic Neisseria spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenic Neisseria spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.

Submission Summary (Full Text)

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K993033

510(k) Summary

BioMed Diagnostics Incorporated has gought premarket approval for its proprietary InTrayTM GC packaging of MTM media for isolation of pathogenic Neisseria, (83JTY).

Classification Name:

Culture Medium, for isolation of pathogenic Neisseria, (83JTY) .

Common/Usual Name: Gonorrhoea isolation medium.

Trade/Proprietary Name: InTrayTM GC

The InTray GC contains a Modified Thayer-Martin (MTM) medium within a sealed inner well. It has a two inch
diameter well and 5-6ml of media. The inner seal that covers this well also covers another 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 reseals this outer label. In practice, when the user opens the outer seal, he may then remove and discard the inner seal exposing the surface of the medium and the sealed cavity. The next step is to inoculate the surface of the medium with the patient sample. Next, puncture the seal over the cavity with any convenient sharp point. Finally, reseal the outer label over the InTray. High humidity within the InTray causes the tablet to generate · CO2. Incubate the InTray and observe the growth of organisms through the window without opening the InTray and therefore without disturbing the atmosphere. Observation can be by eye, hand lens or microscope. This packaging has been used since 1994 for other BioMed media products.

Two one year studies were performed comparing the performance of room temperature stored InTray GC against fresh commercial MTM and chocolate media. Tests were performed in the laboratory using pure cultures at 102 cfu for each of four strains of N. gonorrhoeae and at 105 cfu for competing organisms. The four strains of N. gonorrhoeae included the NCCLS standard strain and three others drawn from a world wide data base. One of them was an AHU auxotype known to be difficult to grow. For two of the strains, recovered colony counts were comparable to fresh commercially prepared media. For the other two, colony counts were about half compared to fresh commercial media. In no case was there failure to recover the organism.

1430 Koll Circle, Suite 101, San Jose, CA 95112 • Tel [phone] • Fax [phone]

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The potential contaminants that were tested include N. sicca, E. coli, S. epidermidis, P. mirabilis and C. albicans. After one year at room temperature, the InTray GC was superior to fresh commercial media in suppressing growth of these organisms.

A clinical study was performed with 228 female patients using cervical swabs. Results positive for N. gonorrhoeae were identical to those for commercially prepared media, 18 positive, 210 negative. The principal contaminant was C. albicans with 17 positive for the InTray GC and 30 positive with the comparison MTM medium. There were no adverse indications in these tests.

In conclusion, the laboratory tests established the presumption of effectiveness and safety which was borne out by the clinical testing. The evidence indicates that InTray GC is superior for shelf life, ease of observation and suppression of C. albicans.

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DEC 1 6 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert D. Hall President BioMed Diagnostics, Inc. 1430 Koll Circle, Suite 101 San Jose, California 95112

Re: K993033 Trade Name: InTray™ GC Regulatory Class: II Product Code: JTY Dated: September 3, 1999 Received: November 23, 1999

Dear Mr. Hall:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K993033

Device Name: InTray™ GC

Indications For Use:

InTray GC is used, like conventional Thayer-Martin media plates, to grow Neisseria gonomhoeae and similar organisms.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubocs

n of Clinical Laboratory Devices K44303 510(k) Number

Prescription Use_Y (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)