(84 days)
Not Found
No
The description details a traditional automated susceptibility testing method based on minimum inhibitory concentration (MIC) determination through miniaturized doubling dilution. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is a laboratory aid for in vitro susceptibility testing of antimicrobial agents, not a device used for therapy.
Yes
The VITEK® 2 Gram Negative Ceftazidime/Avibactam is designed for antimicrobial susceptibility testing, providing quantitative results (MIC values and interpretive category results) for antimicrobial agents against various Gram-negative bacilli, which aids in determining the in vitro susceptibility to these agents. This directly contributes to diagnosing the susceptibility of microorganisms to specific antimicrobial agents, a function of a diagnostic device.
No
The device description explicitly states that the VITEK® 2 AST Cards are miniaturized versions of a physical laboratory technique and are used with the VITEK® 2 and VITEK® 2 Compact Systems, which are described as instruments that fill, seal, and incubate the cards. This indicates a significant hardware component is integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: 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." This clearly indicates it's used to test samples in vitro (outside the body) to provide information for diagnosis or treatment.
- Device Description: The description details a laboratory test method ("miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology") performed on isolated colonies.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard laboratory technique for determining antimicrobial susceptibility.
- Intended User: The intended user is a "laboratory aid," further confirming its use in a clinical laboratory setting.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Negative Ceftazidime/Avibactam 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 Ceftazidime/ Avibactam is a quantitative test. Ceftazidime/Avibactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections:
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa
The following in vitro data are available, but clinical significance is unknown:
Citrobacter koseri
Enterobacter aerogenes
Morganella morganii
Providencia stuartii
Serratia marcescens
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., Streptococcus spp., Streptococcus spp. and clinically significant yeast.
Product codes
LON, LTW, LTT
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 Ceftazidime/Avibactam by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs.
Summary of Performance Studies
Study type: External evaluation comparing VITEK® 2 AST-GN Ceftazidime/Avibactam performance with the CLSI broth microdilution reference method.
Sample size: Not explicitly stated, but the major error rate calculation mentions 998 for the denominator of the adjusted categorical major error rate.
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results:
Overall Performance (with the reference method):
% Essential Agreement (EA): 94.5
% Category Agreement (CA): 98.7
The overall categorical major error rate for Entervase and Pseudomonas 1.4% (14/998). Nine (9) major errors were one dilution apart from the reference method and as such fall within essential agreement, and the lack of an intermediate breakpoint for Ceftazidime/Avibactam, the adjusted categorical major error rate is 0.5% (5/998).
Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics
Essential Agreement (EA): 94.5%
Category Agreement (CA): 98.7%
Overall categorical major error rate for Entervase and Pseudomonas: 1.4% (14/998)
Adjusted categorical major error rate: 0.5% (5/998)
Predicate Device(s)
VITEK® 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥ 32 ug/ml) (K161510)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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December 19, 2017
bioMerieux, Inc. Ms. Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K172944
Trade/Device Name: VITEK 2 AST-GN Ceftazidime/Avibactam (16 ug/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system Regulatory Class: Class II Product Code: LON, LTW, LTT Dated: September 25, 2017 Received: September 26, 2017
Dear Ms. Cherece 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 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
1
Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Ribhi Shawar -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
2
Indications for Use
510(k) Number (if known) K172944
Device Name
VITEK® 2 AST-GN Ceftazidime/Avibactam (≤0.12 ->16 µg/mL)
Indications for Use (Describe)
VITEK® 2 Gram Negative Ceftazidime/Avibactam 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 Ceftazidime/ Avibactam is a quantitative test. Ceftazidime/Avibactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections:
Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
The following in vitro data are available, but clinical significance is unknown:
Citrobacter koseri Enterobacter aerogenes Morganella morganii Providencia stuartii Serratia marcescens
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., Streptococcus spp., Streptococcus spp. and clinically significant yeast.
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 Ceftazidime/Avibactam
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: | September 25, 2017 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-GN Ceftazidime/Avibactam (≤0.12 - ≥ 16 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 Ceftazidime/Avibactam |
| C. Predicate Device: | |
| VITEK® 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥ 32 ug/ml) (K161510) |
D. 510(k) Summary:
VITEK® 2 Gram Negative Ceftazidime/Avibactam 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 Ceftazidime/Avibactam is a quantitative test. Ceftazidime/Avibactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections:
5
Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
The following in vitro data are available, but clinical significance is unknown:
Citrobacter koseri Enterobacter aerogenes Morganella morganii Providencia stuartii Serratia marcescens
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 Ceftazidime/Avibactam 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 Ceftazidime/Avibactam. 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
6
the acceptability of VITEK® 2 AST-GN Ceftazidime/Avibactam 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 Compact instrument platforms.
The VITEK® 2 AST-GN Ceftazidime/Avibactam (≤ 0.12 – ≥ 16 µg/mL) demonstrated acceptable performance as presented in Table 1 below:
Table 1: Performance Characteristics for VITEK® 2 AST-GN Ceftazidime/Avibactam (ڪ 0.12 – ≥ 16 µg/mL)
| % Essential Agreement | % Category Agreement* | |
|---|---|---|
| (EA) | (CA) | |
| Overall Performance (with the | ||
| reference method) | 94.5 | 98.7 |
- The overall categorical major error rate for Entervase and Pseudomonas 1.4% (14998). Nine (9) major errors were one dilution apart from the reference method and as such fall within essential agreement, and the lack of an intermediate breakpoint for Ceftazidime/Avibactam, the adjusted categorical major error rate is 0.5% (5/998).
Reproducibility and Quality Control demonstrated acceptable results.