(46 days)
The Liofilchem® MTST™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTST™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The MTST™ Eravacycline at concentrations of 0.002 - 32 µg/mL should be interpreted at 16-20 hours of incubation.
MTST™ Eravacycline can be used to determine the MIC of eravacycline against the following bacteria.
Eravacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:
Gram-positive bacteria
Enterococcus faecalis
Enterococcus faecium
Staphylococcus aureus
Gram-negative bacteria
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Eravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label:
Citrobacter koseri
Klebsiella (Enterobacter) aerogenes
MTST™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.
The provided text describes the 510(k) premarket notification for the Liofilchem® MTST™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL. This device is an antimicrobial susceptibility test (AST) that determines the minimum inhibitory concentration (MIC) of eravacycline against certain bacteria.
However, the provided document is a clearance letter and an indications for use statement. It does not contain the detailed study results, acceptance criteria, or the methodology of the studies used to prove the device meets its performance requirements. Typically, this information would be found in the 510(k) submission itself or in a summary document (e.g., a 510(k) Summary or 510(k) Review Memorandum) which is often publicly available from the FDA.
Therefore, based solely on the provided text, I cannot fulfil the request to describe the acceptance criteria and the study that proves the device meets them, as the relevant information is absent. I can only infer what kind of study was likely performed based on the device type.
What is present in the document:
- Device: Liofilchem® MTST™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL
- Regulation Number/Name: 21 CFR 866.1640, Antimicrobial susceptibility test powder
- Intended Use: Quantitative method for in vitro determination of antimicrobial susceptibility of bacteria, specifically for determining MIC of eravacycline against listed Gram-positive and Gram-negative bacteria.
- Performance Claim: The device measures MICs against specific bacteria.
What is NOT present in the document (and thus cannot be answered):
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or training set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts, their qualifications, or adjudication methods for ground truth.
- Information on Multi Reader Multi Case (MRMC) comparative effectiveness studies or effect sizes.
- Stand-alone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) or how it was established for training/test sets.
To provide the requested information, a different document detailing the device's validation studies would be needed.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is the acronym FDA in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 2, 2018
Liofilchem s. r. 1. % Laura Koeth President Laboratory Specialists, Inc 26214 Center Ridge Road Westlake, Ohio 44145
Re: K182557
Trade/Device Name: MTS Eravacycline 0.002 - 32 ug/mL Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY Dated: September 14, 2018 Received: September 17, 2018
Dear Ms. Koeth:
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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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.
Steven R. Gitterman -S 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. | Indications for Use |
|---|---|---|
| 510(k) Number (if known) | K182557 | |
| Device Name | MTST™ Eravacycline 0.002-32 µg/mL | |
| Indications for Use (Describe) | The Liofilchem® MTST™ (MIC Test Strip) Eravacycline 0.002-32 µg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTST™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in µg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures.The MTST™ Eravacycline at concentrations of 0.002 - 32 µg/mL should be interpreted at 16-20 hours of incubation.MTST™ Eravacycline can be used to determine the MIC of eravacycline against the following bacteria.Eravacycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label: | |
| Gram-positive bacteriaEnterococcus faecalisEnterococcus faeciumStaphylococcus aureusGram-negative bacteriaCitrobacter freundiiEnterobacter cloacaeEscherichia coliKlebsiella oxytocaKlebsiella pneumoniae | ||
| Eravacycline has been shown to be active in vitro only against the non-fastidious bacteria listed below according to the FDA drug approved label: | ||
| Citrobacter koseriKlebsiella (Enterobacter) aerogenes | ||
| 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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ਦੂਰ
- 2012-04-04
ੂ
୍କ ସେ
a
- 2017-02-04
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).