(257 days)
VITEK® 2 GN Doxycycline (K121546)
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No
The description focuses on a miniaturized doubling dilution technique and automated monitoring of bacterial growth, with no mention of AI or ML algorithms for interpretation or analysis.
No
This device is designed for in vitro antimicrobial susceptibility testing, providing information for laboratory use, not for direct therapeutic intervention in a patient.
Yes
The device is designed for "antimicrobial susceptibility testing of Gram negative bacilli" and acts as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," which are diagnostic activities.
No
The device description clearly describes a physical AST card and its interaction with the VITEK® 2 and VITEK® 2 Compact Systems, which are hardware instruments. The software component is part of the larger system that processes the results from the physical card.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "designed for antimicrobial susceptibility testing of Gram negative bacilli" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details how the device tests isolated colonies in a laboratory setting using a miniaturized version of a standard laboratory technique (doubling dilution). This process is performed outside of the living organism.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard laboratory method for determining antimicrobial susceptibility. This further confirms its use in a laboratory setting for diagnostic purposes.
- Intended User / Care Setting: The intended user is described as a "laboratory aid," reinforcing its use in a clinical laboratory environment.
Therefore, the VITEK® 2 Gram Negative Ceftolozane Tazobactam device, as described, clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Negative Ceftolozane Tazobactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Gram Negative Ceftolozane/Tazobactam is a quantitative test. Ceftolozane Tazobactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
In vitro data available but clinical significance is unknown Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Proteus vulgaris Providencia stuartii Serratia liquefacians
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococus spp., Enterococcus spp. and clinically significant yeast
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
The antimicrobial presented in VITEK® 2 AST-GN Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory aid
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
An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GN Ceftolozane/Tazobactam by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 AST-GN Ceftolozane/Tazobactam demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009). The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GN Ceftolozane/Tazobactam. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GN Ceftolozane/Tazobactam by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Ceftolozane/Tazobactam demonstrated acceptable performance of 94.8% overall Essential Agreement and 98.4% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: 94.8%
Category Agreement: 98.4%
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.
VITEK® 2 GN Doxycycline (K121546)
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
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2017
BIOMÉRIEUX, INC CHERECE JONES STAFF REGULATORY AFFAIRS SPECIALIST 595 ANGLUM RD. HAZELWOOD MO 63042
Re: K161510
Trade/Device Name: VITEK 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥ 32 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON, LTW, LTT Dated: January 12, 2017 Received: January 13, 2017
Dear Ms. Jones:
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, 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ribhi Shawar -A
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
2
Indications for Use
510(k) Number (if known) K161510
Device Name
VITEK® 2 AST-GN Ceftolozane/Tazobactam (≤0.25 ->32 µg/mL)
Indications for Use (Describe)
VITEK® 2 Gram Negative Ceftolozane Tazobactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Gram Negative Ceftolozane/Tazobactam is a quantitative test. Ceftolozane Tazobactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
In vitro data available but clinical significance is unknown Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Proteus vulgaris Providencia stuartii Serratia liquefacians
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococus spp., Enterococcus spp. and clinically significant yeast
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY
VITEK® 2 AST-GN Ceftolozane/Tazobactam
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Cherece L. Jones |
| Staff Regulatory Affairs Specialist | |
| Phone Number: | 314 -731-8684 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | May 31, 2016 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-GN Ceftolozane/Tazobactam (≤ 0.25 - |
32 µg/mL) |
| Classification Name: | 21 CFR 866.1645
Fully Automated Short-Term Incubation Cycle
Antimicrobial Susceptibility System
Product Code LON |
| Common Name: | VITEK® 2 AST-GN Ceftolozane/Tazobactam |
| Predicate Device: | VITEK® 2 GN Doxycycline (K121546) |
D. 510(k) Summary:
B.
C.
VITEK® 2 Gram Negative Ceftolozane/Tazobactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK®2 Gram Negative Ceftolozane/Tazobactam is a quantitative test. Ceftolozane/Tazobactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections Enterobacter cloacae
5
Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
In vitro data available but clinical significance is unknown Citrobacter freundii Citrobacter koseri Enterobacter aerogenes Enterobacter cloacae Proteus vulgaris Providencia stuartii Serratia liquefacians
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast
The antimicrobial presented in VITEK® 2 AST-GN Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.
VITEK® 2 AST-GN Ceftolozane/Tazobactam demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009).
The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GN Ceftolozane/Tazobactam. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GN Ceftolozane/Tazobactam by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs. The data is
6
representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Ceftolozane/Tazobactam demonstrated acceptable performance of 94.8% overall Essential Agreement and 98.4% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.