(46 days)
Not Found
No
The description focuses on automated quantitative or qualitative susceptibility testing using a miniaturized doubling dilution technique and monitoring growth over time. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a "laboratory aid" for "antimicrobial susceptibility testing" and provides "in vitro susceptibility" information, which helps determine the effectiveness of antimicrobials rather than directly treating a condition.
Yes
The device is designed for "antimicrobial susceptibility testing of Gram positive microorganisms" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This information is used to help determine the most effective treatment for an infection, which is a diagnostic purpose.
No
The device description explicitly details hardware components (VITEK® 2 AST Cards, VITEK® 2 and VITEK® 2 Compact Systems) and their physical interactions (filling, sealing, incubation, reading). While software is involved in data processing and reporting, the core functionality relies on physical hardware and consumables.
Based on the provided text, the 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 Gram positive microorganisms" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a test performed on isolated colonies (microorganisms grown outside the body) using a miniaturized version of a laboratory technique (doubling dilution). This is characteristic of an in vitro test.
- Performance Studies: The performance studies compare the device's performance to a "CLSI broth microdilution reference method," which is a standard laboratory method for determining antimicrobial susceptibility in vitro.
- Predicate Device: The predicate device listed (K122547 VITEK® 2 AST-GP Clindamycin) is also an antimicrobial susceptibility test, which are typically classified as IVDs.
All these points strongly indicate that the VITEK® 2 Gram Positive Ceftaroline is a device used to perform tests on biological samples outside the body to provide information for diagnosis or treatment, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Positive Ceftaroline is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Ceftaroline is a quantilative test. Ceftaroline has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections Staphylococcus aureus (including methicillin-susceptible and -resistant isolates) 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 arrobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., and clinically significant yeast.
Product codes
LON
Device Description
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 microorganisms, Staphylococcus spo., Enterococcus spo., Streptococcus spp. and clinically significant yeast. The antimicrobial presented in VITEK 2 AST-GP 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
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
An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GP strains. Ceftaroline by comparing its performance with the CLSI broth microdilution reference method incubated at 16 - 20 hrs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 AST-GP Ceftaroline 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.
VITEK 2 AST-GP Ceftaroline demonstrated acceptable performance of 97.9% overall essential Agreement and 99.2% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
97.9% overall essential Agreement and 99.2% overall category agreement.
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.
VITEK® 2 AST-GP Clindamycin (K122547)
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.
Not Found
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).
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
K/41149
Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of the word "BIOMERIEUX" in a stylized font, with a circular symbol above it. The circle is divided in half, with the left half filled with horizontal lines and the right half solid black. A curved line runs vertically through the center of the circle and the text.
JUN 20 2014 VITEK® 2 AST-GP Ceftaroline
Traditional 510(k) Submission
510(k) SUMMARY
VITEK® 2 AST-GP Ceftaroline
510(k) Submission Information:
Submitter's Name: Address:
bioMérieux, Inc.
Charlene Ferrand Regulatory Affairs Officer
314 -731-8630
314-731-8689
21 CFR 866.1645
Product Code LON
595 Anglum Road Hazelwood, MO 63042
Contact Person:
Phone Number:
Fax Number:
Date of Preparation:
April 8th, 2014
VITEK® 2 AST-GP Ceftaroline
Antimicrobial Susceptibility System
VITEK® 2 AST-GP Ceftaroline
B. Device Name:
Formal/Trade Name:
Classification Name:
Common Name:
VITEK® 2 AST-GP Clindamycin (K122547)
Fully Automated Short-Term Incubation Cycle
D. 510(k) Summary:
C. Predicate Device:
VITEK® 2 Gram Positive Ceftaroline is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive Ceftaroline is a quantitative test. Ceftaroline has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections
Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)
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 microorganisms, Staphylococcus spo., Enterococcus spo., Streptococcus spp. and clinically significant yeast.
The antimicrobial presented in VITEK 2 AST-GP Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized
1
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-GP Ceftaroline 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-GP Ceftaroline. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-GP strains. Ceftaroline 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 and VITEK® 2 Compact instrument platforms. VITEK 2 AST-GP Ceftaroline demonstrated acceptable performance of 97.9% overall essential Agreement and 99.2% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is horizontally oriented and appears to be a header or title. The font is a sans-serif typeface, and the overall impression is one of official documentation or signage.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BIOMERIEUX, INC. CHARLENE FERRAND 595 ANGLUM RD. HAZELWOOD MO 63042-2320
June 20, 2014
Re: K141149
Trade/Device Name: VITEK® 2 AST-GP Ceftaroline ( Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Ribhi Shawar -S 2014.06.20 11:01:26 -04'00'
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