HardyDisk AST Plazomicin 30ug (PLZ30)
Device Facts
| Record ID | K181700 |
|---|---|
| Device Name | HardyDisk AST Plazomicin 30ug (PLZ30) |
| Applicant | Hardy Diagnostics |
| Product Code | JTN · Microbiology |
| Decision Date | Jul 10, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.1620 |
| Device Class | Class 2 |
Device Story
HardyDisk AST Plazomicin 30ug (PLZ30) is an antimicrobial susceptibility test (AST) disc used in clinical microbiology laboratories. The device consists of a paper disc impregnated with 30ug of the antibiotic Plazomicin. It is used to determine the susceptibility of microorganisms to Plazomicin by measuring the zone of inhibition around the disc on agar media. The test is performed by laboratory professionals to guide clinical decision-making regarding antibiotic therapy for patients with bacterial infections.
Technological Characteristics
Antimicrobial susceptibility test disc; 30ug Plazomicin concentration; paper disc format; Class II device (21 CFR 866.1620); Product Code JTN.
Regulatory Classification
Identification
An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure by a disc-agar diffusion technique or a disc-broth elution technique the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents. In the disc-agar diffusion technique, bacterial susceptibility is ascertained by directly measuring the magnitude of a zone of bacterial inhibition around the disc on an agar surface. The disc-broth elution technique is associated with an automated rapid susceptibility test system and employs a fluid medium in which susceptibility is ascertained by photometrically measuring changes in bacterial growth resulting when antimicrobial material is eluted from the disc into the fluid medium. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.
Related Devices
- K993993 — HARDYDISK AMIKACIN 30MCG · Hardy Diagnostics · Dec 27, 1999
- K183298 — HardyDisk AST Omadacycline 30µg (OMC30) · Hardy Diagnostics · Jan 18, 2019
- K994063 — HARDYDISK AZTREONAM, 30MCG · Hardy Diagnostics · Jan 14, 2000
- K093807 — HARDYDISK AST TELAVANCIN,30UG · Hardy Diagnostics · Jan 8, 2010
- K152838 — HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 · Hardy Diagnostics · Nov 24, 2015
Submission Summary (Full Text)
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July 10, 2018
Hardy Diagnostics Anna Klavins Performance Studies Microbiologist 1430 West McCoy Lane Santa Maria, California 93455
Re: K181700
Trade/Device Name: HardyDisk AST Plazomicin 30ug (PLZ30) Regulation Number: 21 CFR 866.1620 Regulation Name: Antimicrobial susceptibility test disc Regulatory Class: Class II Product Code: JTN Dated: June 25, 2018 Received: June 27, 2018
Dear Anna Klavins:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health 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 <i>one</i> or <i>both</i> , as applicable) |
|----------------------------------------------------------------|
|----------------------------------------------------------------|
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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