(95 days)
No
The description focuses on a traditional microdilution method and automated reading of growth, with no mention of AI/ML algorithms for interpretation or analysis.
No
The device is an in vitro diagnostic (IVD) tool used for antimicrobial susceptibility testing to aid in determining the in vitro susceptibility of certain bacteria to antimicrobial agents. It is not designed to treat a disease or condition.
Yes
The device is described as an "antimicrobial susceptibility testing" device designed to determine "in vitro susceptibility to antimicrobial agents" and provides "MIC value along with the interpretive category result for each antibiotic". This directly aids in diagnosing and guiding treatment for bacterial infections.
No
The device description explicitly details physical components (AST Cards, VITEK 2 System, VITEK 2 COMPACT) and processes involving bacterial isolates and incubation, indicating it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "designed for antimicrobial susceptibility testing" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates it is used to test samples outside of the body (in vitro) to provide diagnostic information.
- Device Description: The description details how the device works by testing bacterial isolates diluted in saline and monitoring their growth in the presence of antimicrobial agents. This is a classic method used in in vitro diagnostic testing for antimicrobial susceptibility.
- Anatomical Site: The "Not Applicable (in vitro diagnostic device)" entry further confirms its nature as an IVD.
- Intended User / Care Setting: The intended user is a "laboratory aid," which aligns with the use of IVDs in a laboratory setting.
Therefore, based on the provided information, the VITEK®2 Gram Negative Piperacillin/Tazobactam is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK®2 Gram Negative Piperacillin/Tazobactam is designed for antimicrobial susceptibility testing of Acinetobacter baumanii. Escherichia coli. Klebsiella pneumoniae. Pseudomonas aeruginosa, Citrobacter koseri, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, and Salmonella enterica. It 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. The antimicrobial presented in VITEK 2 AST 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.
Product codes
LON, LTW, LTT
Device Description
The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System 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 cvcle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic 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
Not Found
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
Not Found
Summary of Performance Studies
VITEK 2 Gram Neqative Piperacillin/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 Feb. 5, 2003.
This submission is the result of a FDA 2019 breakpoint change, as published on the FDA STIC website, for Pseudomonas aeruginosa tested with Piperacillin/Tazobactam (≤16, 32-64, 128 ≥). The intended use of the VITEK 2 Gram Negative Piperacillin/Tazobactam, as described in the labeling (package insert), has not changed as a result of this modification to the breakpoints specific to Pseudomonas aeruginosa. The overall performance of the device has been updated to reflect the performance of Pseudomonas aeruginosa when the updated breakpoints are applied. This modification does not affect the fundamental scientific technology of this device.
This premarket Notification (510(k)) presents the data in support of the VITEK 2 Gram Negative Piperacillin/Tazobactam test when the updated breakpoints for Pseudomonas aeruginosa (≤16, 32-64, 128 ≥) are applied. The data are representative of performance on both the VITEK 2 and VITEK 2 COMPACT instrument platforms. VITEK 2 Gram Negative Piperacillin/Tazobactam demonstrated an overall acceptable performance of 92.3% Category Agreement. Quality control and reproducibility are acceptable and remain unchanged from the original clearance (K113200).
The VITEK 2 Gram Neqative Piperacillin/Tazobactam test demonstrated acceptable performance during verification of the breakpoint change specific to Pseudomonas aeruginosa. No new risks were introduced through this modification and the performance equivalency has been established through verification testing. This allows for a substantial equivalence decision when compared to the current device cleared under K113200.
Key Metrics
92.3% Category Agreement.
Predicate Device(s)
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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August 30, 2021
bioMérieux, Inc Mary Beth Anheuser Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042 USA
Re: K211630
Trade/Device Name: VITEK 2 AST-Gram Negative Piperacillin / Tazobactam ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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Special 510(k) SUMMARY
VITEK ®2 Gram Negative Piperacillin/Tazobactam Special 510(k): Device Modification
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Mary Beth Anheuser |
| Staff, Regulatory Affairs Specialist | |
| Phone Number: | 618-667-3179 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | May 25, 2021 |
| Formal/Trade Name: | VITEK® 2 Gram Negative Piperacillin/Tazobactam |
| (≤4 - ≥128 µg/mL) | |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GN Piperacillin/Tazobactam |
| Predicate Device: | VITEK 2 AST-GN Piperacillin/Tazobactam (K113200) |
D. 510(k) Summary:
B.
C.
VITEK®2 Gram Negative Piperacillin/Tazobactam is designed for antimicrobial susceptibility testing of Acinetobacter baumanii. Escherichia coli. Klebsiella pneumoniae. Pseudomonas aeruginosa, Citrobacter koseri, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, and Salmonella enterica. It 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. The antimicrobial presented in VITEK 2 AST 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 bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System 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
bioMérieux, Inc.
595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700
4
the incubation cvcle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.
VITEK 2 Gram Neqative Piperacillin/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 Feb. 5, 2003.
This submission is the result of a FDA 2019 breakpoint change, as published on the FDA STIC website, for Pseudomonas aeruginosa tested with Piperacillin/Tazobactam (≤16, 32-64, 128 ≥). The intended use of the VITEK 2 Gram Negative Piperacillin/Tazobactam, as described in the labeling (package insert), has not changed as a result of this modification to the breakpoints specific to Pseudomonas aeruginosa. The overall performance of the device has been updated to reflect the performance of Pseudomonas aeruginosa when the updated breakpoints are applied. This modification does not affect the fundamental scientific technology of this device.
This premarket Notification (510(k)) presents the data in support of the VITEK 2 Gram Negative Piperacillin/Tazobactam test when the updated breakpoints for Pseudomonas aeruginosa (≤16, 32-64, 128 ≥) are applied. The data are representative of performance on both the VITEK 2 and VITEK 2 COMPACT instrument platforms. VITEK 2 Gram Negative Piperacillin/Tazobactam demonstrated an overall acceptable performance of 92.3% Category Agreement. Quality control and reproducibility are acceptable and remain unchanged from the original clearance (K113200).
The VITEK 2 Gram Neqative Piperacillin/Tazobactam test demonstrated acceptable performance during verification of the breakpoint change specific to Pseudomonas aeruginosa. No new risks were introduced through this modification and the performance equivalency has been established through verification testing. This allows for a substantial equivalence decision when compared to the current device cleared under K113200.