(36 days)
No
The description focuses on a traditional automated susceptibility testing method based on growth monitoring and comparison to a reference method, with no mention of AI or ML.
No.
This device is an in vitro diagnostic (IVD) device used in a laboratory setting to determine antimicrobial susceptibility, which aids in diagnosis and treatment decisions. It does not directly provide therapy.
Yes
Explanation: The device is intended for antimicrobial susceptibility testing and helps in determining in vitro susceptibility to antimicrobial agents, which are diagnostic processes for identifying appropriate treatments. It provides quantitative or qualitative susceptibility testing of isolated colonies for various bacteria.
No
The device description clearly details physical components like "AST Cards," "antimicrobial medium," and the "VITEK 2 System" and "VITEK 2 Compact" instruments which are hardware. The software is part of a larger hardware system.
Based on the provided information, 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 of Streptococcus pneumoniae" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Device Description: The description details a test performed on a bacterial isolate (outside the body) using a miniaturized microdilution methodology to determine the minimum inhibitory concentration (MIC). This process is conducted in a laboratory setting.
- Performance Studies: The performance studies compare the device's performance to a "CLSI broth microdilution reference method," which is a standard laboratory technique for in vitro testing.
- Intended User / Care Setting: The intended user is described as a "laboratory aid," further indicating its use in a clinical laboratory setting for diagnostic purposes.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 Gram Positive Meropenem for Streptococcus pneumoniae is a quantitative test. 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 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 isolated colonies for the most clinically significant aerobic gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
Product codes
LON
Device Description
VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. 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 the incubation cycle, 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
laboratory aid
Description of the training set, sample size, data source, and annotation protocol
An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Meropenem for Streptococcus pneumoniae by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002.
Key Metrics
97.3% overall Essential Agreement and 92.9% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
Predicate Device(s)
Reference Device(s)
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.”
0
JAN 1 1 2007
510(k) SUMMARY
VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae
B : D M &
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenllado |
| Senior Regulatory Affairs Specialist | |
| Phone Number: | 314 -731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | December 4, 2006 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Meropenem for Streptococcus |
| pneumoniae | |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GP Meropenem for Streptococcus |
| pneumoniae | |
| Predicate Device: | VITEK 2 Gram Positive Telithromycin for Streptococcus |
| pneumoniae (K053186). |
D. 510(k) Summarv:
B.
C.
VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. 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 the incubation cycle, 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 Positive Meropenem for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as
1
defined in the FDA Class II Special Controls 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 for Streptococcus pneumoniae. An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Meropenem for Streptococcus pneumoniae by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK 2 Gram Positive Amoxicillin for Streptococcus pneumoniae demonstrated acceptable performance of 97.3% overall Essential Agreement and 92.9% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jolyn Tenllado Senior Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
IJAN 1 1 2007
Re: K063623 Trade/Device Name: VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae ( 4 µg/ml)
Indications For Use:
VITEK® 2 Gram Positive Meropenem for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. VITEK 2 Gram Positive Meropenem for Streptococcus pneumoniae is a quantitative test. 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 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 isolated colonies for the most clinically significant aerobic gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Freddie Poole
Division Sign-Off
Office of in Vitro Diagnostic Device Evaluation and Sa
K06 3263