(42 days)
N50510/S141
No
The description focuses on automated quantitative/qualitative susceptibility testing using miniaturized dilution techniques and monitoring bacterial growth. There is no mention of AI or ML algorithms being used for analysis or interpretation. The performance studies compare the device to a reference method, not evaluating an AI/ML model.
No.
The device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," which means it helps in diagnosing or guiding treatment by identifying which antibiotics might be effective, rather than directly treating a condition.
Yes
The device is intended to be used for automated quantitative or qualitative susceptibility testing of clinically significant aerobic gram-positive cocci, and serves as a laboratory aid in determining in vitro susceptibility to antimicrobial agents, which directly contributes to diagnostic information.
No
The device description clearly outlines physical components (AST cards, VITEK 2 and VITEK 2 Compact Systems) that perform automated filling, sealing, incubation, and reading, indicating it is a hardware-based system with integrated 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's for "in vitro susceptibility testing" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description details how the device tests bacterial isolates in a laboratory setting using a miniaturized dilution technique. This process is performed outside of the body (in vitro).
- Performance Studies: The performance studies compare the device's results to a reference method for determining antimicrobial susceptibility, which is a common type of evaluation for IVD devices.
The information provided clearly indicates that this device is used to perform tests on biological samples (bacterial isolates) in a laboratory setting to provide information about their susceptibility to antimicrobial agents, which is a core function of an IVD.
N/A
Intended Use / Indications for Use
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of listed spp., Entercoccus spp., Streptococcus agalactiae, and S. pneumoniae.
VITEK® 2 Gram Positive Meropenem is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epidemidis. VITEK 2 Gram Positive Meropenem 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.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
VITEK® 2 Gram Positive Meropenem is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epidermidis. 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 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 systems monitor 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 along with the interpretive category result for each antibiotic contained on the card.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the and stock challerige of VITEK 2 Gram Positive Meropenem by comparing its performance with the CLSI (NCCLS) agar dilution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 Gram Positive Meropenem demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the FDA when comparis with and Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003.
The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Meropenem. An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the and stock challerige of VITEK 2 Gram Positive Meropenem by comparing its performance with the CLSI (NCCLS) agar dilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms, as performance the AST Equivalency Study presented in the VITEK 2 Compact premarket notification, K050002. VITEK 2 Gram Positive Meropenem demonstrated acceptable performance of 100% overall Category Agreement when compared to the agar dilution perference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
100% overall Category Agreement when compared to the agar dilution perference method.
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.
N50510/S141
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.
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).
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§ 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.”
0
Image /page/0/Picture/1 description: The image shows the date "MAY 12 2005" in bold, sans-serif font at the top left. Below the date is the word "BIOMÉRIEUX" in a stylized font. To the right of the word is a circular seal with a line extending below it.
510(k) SUMMARY
VITEK® 2 Gram Positive Meropenem
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenllado |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | March 30, 2005 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Meropenem ( |