(35 days)
VITEK 2 Gram Positive AST for Sparfloxacin
No
The description focuses on automated quantitative/qualitative susceptibility testing using miniaturized microdilution methodology and monitoring bacterial growth over time. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is a laboratory aid for determining the in vitro susceptibility of bacteria to antimicrobial agents, not a device for treating a patient's condition.
Yes
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is used to determine the in vitro susceptibility of bacteria to antimicrobial agents, providing results (MIC values and interpretive categories) that aid laboratories in determining the appropriate treatment for infections.
No
The device description clearly outlines physical components like VITEK 2 AST Cards, saline, and the VITEK 2 and VITEK 2 Compact Systems which are hardware. The software is part of a larger system that includes hardware for incubation, reading, and processing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "in vitro susceptibility testing of isolated colonies of clinically significant aerobic gram positive bacteria" 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 to provide information for diagnosis or treatment.
- Device Description: The description details how the device interacts with bacterial isolates (samples taken from a patient) and performs tests on them in a laboratory setting.
- Care Setting: The intended user is a "laboratory aid," further reinforcing its use in a clinical laboratory environment for diagnostic purposes.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, taken from the human body, to detect diseases, conditions, or infections. This device fits that description by testing bacterial isolates from patients to determine their susceptibility to antibiotics, which is crucial information for guiding treatment decisions.
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 isolates of typically significant aerobic gram-positive organisms such as Enterococcus spp., Staphylococcus spp., and Streptococcus spp., and Streptococcus agalactiae, and S. pneumoniae.
VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole is designed for Trimethoprim/ sulfamethoxazole susceptibility testing of Staphylococcus aureus. VITEK 2 Gram Positive Trimethoprim/sulfamethoxazole is a qualitative 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.
Product codes
LON
Device Description
VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole is designed for antimicrobial susceptbility VITER 2 Oran't oolare himourophin since with the VITEK® 2 and 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 r he unlinerebial procentrations in mcg/mi. 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 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive The Premiation (o ro[it]) procente levaluation was conducted with fresh and stock Trined isolates and stock challenge strains. The external evaluations were designed to confirm the cillitical solates and stock onailer Trimethoprim/ suffamethoxazole by comparing its acceptablily of VTLR 2 Oran Positive minorition reference method.
Data source: fresh and stock clinical isolates and stock challenge strains.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 Gram Positive Trimethoprim/sulfamethoxazole demonstrated substantially equivalent performance when compared with the NCCLS reference macrobroth dilution 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. The data is representative of performance with the NOOLS macrosition relevel instrument platforms, as evidenced in the periormance on bout the VTTEK 2 and VTER 2 Compact file, K050002 . VITEK 2 Gram Positive AST equivalency study presented in the VITER a Company of 99.6% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99.6% overall Category Agreement
Predicate Device(s)
VITEK 2 Gram Positive AST for Sparfloxacin
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
Image /page/0/Picture/1 description: The image shows the logo for BioMerieux. The logo consists of the company name in a stylized font, with a circular graphic above it. A thin line extends vertically through the center of the circle and the text.
MAY 2 3 2005
VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Nancy Weaver |
| Staff Regulatory Affairs Specialist | |
| Phone Number. | 314-731-8695 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | April 12, 2005 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GP SXT |
| Prodicate Device: | VITEK 2 Gram Positive AST for Sparfloxacin |
D. 510(k) Summary:
C. Predicate Device:
B.
VITEK® 2 Gram Positive Trimethoprim/sulfamethoxazole is designed for antimicrobial susceptbility VITER 2 Oran't oolare himourophin since with the VITEK® 2 and 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 r he unlinerebial procentrations in mcg/mi. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
(N50510/S141)
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 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 Trimethoprim/sulfamethoxazole demonstrated substantially equivalent performance when compared with the NCCLS reference macrobroth dilution 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.
bioMérieux, Inc.
800/638-4835 Fax: 314/731-Phone: 314/731-8500 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA 8700
1
The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive The Premiation (o ro[it]) procente levaluation was conducted with fresh and stock Trined isolates and stock challenge strains. The external evaluations were designed to confirm the cillitical solates and stock onailer Trimethoprim/ suffamethoxazole by comparing its acceptablily of VTLR 2 Oran Positive minorition reference method. The data is representative of performance with the NOOLS macrosition relevel instrument platforms, as evidenced in the periormance on bout the VTTEK 2 and VTER 2 Compact file, K050002 . VITEK 2 Gram Positive AST equivalency study presented in the VITER a Company of 99.6% 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 3 2005
Ms. Nancy Weaver Staff Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
K050976 Re:
K02070
Trade/Device Name: VITEK® 2 Gram Positive Trimethoprim/Sulfamethoxazole (