(66 days)
K031410, K00510/S135
K031410, K00510/S135, N50510/S135
No
The description focuses on a traditional microdilution methodology and automated reading of growth, with no mention of AI/ML terms or processes.
No
The device is described as a "laboratory aid" for "antimicrobial susceptibility testing" and does not directly treat or diagnose a disease.
Yes
The device is designed for antimicrobial susceptibility testing and is intended for use as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents, which is a diagnostic purpose. It determines the minimum inhibitory concentration (MIC) of antibiotics against a bacterial isolate.
No
The device description clearly outlines physical components (AST Cards, VITEK 2 System) and a process involving rehydration, filling, sealing, incubation, and reading, 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 of Streptococcus pneumoniae" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates it is used to test samples in vitro (outside the body) to provide information about a patient's condition (in this case, the susceptibility of a bacterial infection to antibiotics).
- Device Description: The description details a method for testing bacterial isolates in a laboratory setting using a standardized procedure and a specialized card. This is a typical description of an IVD.
- Performance Studies: The description of performance studies involves comparing the device's results to a reference method using clinical isolates, which is a standard practice for validating IVDs.
- Predicate Device: The mention of a predicate device (VITEK 2® Streptococcus pneumoniae Susceptibility Test for Ceftriaxone) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
The core function of the device is to analyze a biological sample (bacterial isolate) in vitro to provide diagnostic information (antimicrobial susceptibility), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"VITEK 2® Gram Positive Linezolid for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the VITEK 2® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents."
Product codes
LON
Device Description
"The VITEK 2® Gram Positive Linezolid for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the VITEK 2® System 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) my 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 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
"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 Linezolid for Streptococcus pneumoniae by comparing its performance with the NCCLS microbroth dilution reference method."
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
"VITEK 2® Gram Positive Linezolid for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the NCCLS reference microbroth dilution method, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial susceptibility Devices", dated March 8, 2000 and 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 Linezolid 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 Linezolid for Streptococcus pneumoniae by comparing its performance with the NCCLS microbroth dilution reference method. VITEK 2 Gram Positive Linezolid for Streptococcus pneumoniae demonstrated acceptable performance of 100.0% overall Category Agreement when compared to the microbroth dilution reference method. Reproducibility and Quality Control demonstrated acceptable results."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
"100.0% overall Category Agreement"
Predicate Device(s)
K031410 is substantially equivalent to K00510/S135
VITEK 2® Streptococcus pneumoniae Susceptibility Test for Ceftriaxone (N50510/S135)
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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Image /page/0/Picture/0 description: The image shows a date and a company name. The date is "JUL 10 2003", indicating July 10th, 2003. Below the date, the company name "BIOM ÉRIE U X" is printed in a stylized font. There is also a black circle between the date and the company name.
K0314/10
510(k) SUMMARY
VITEK 2® Gram Positive Linezolid for Streptococcus pneumoniae
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Nancy Weaver, Staff Regulatory Specialist |
| Phone Number: | 314-731-8695 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | April 25, 2003 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK 2® Gram Positive Linezolid for |
| Streptococcus pneumoniae | |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, | |
| 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GP Linezolid for Streptococcus |
| pneumoniae | |
| C. Predicate Device: | VITEK 2® Streptococcus pneumoniae |
| Susceptibility Test for Ceftriaxone (N50510/S135) |
D. 510(k) Summary:
The VITEK 2® Gram Positive Linezolid for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the VITEK 2® System 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) my 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 monitors the growth of each well in the card over a defined period of time (up to 18 hours).
1
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 Linezolid for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the NCCLS reference microbroth dilution method, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial susceptibility Devices", dated March 8, 2000 and 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 Linezolid 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 Linezolid for Streptococcus pneumoniae by comparing its performance with the NCCLS microbroth dilution reference method. VITEK 2 Gram Positive Linezolid for Streptococcus pneumoniae demonstrated acceptable performance of 100.0% overall Category Agreement when compared to the microbroth dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows a logo with a circular border containing text, surrounding a stylized depiction of an eagle. The eagle is composed of three curved lines that suggest the wings and body of the bird. The text around the border is small and difficult to read, but it appears to be part of an organization's name. The logo is simple and uses a monochrome color scheme.
JUL 1 0 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Weaver Staff Regulatory/Clinical Affairs Specialist BioMerieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
Re: K031410 Trade/Device Name: VITEK 2® Gram Positive Linezolid (1 ug/ml) for Streptococcus pneumoniae Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: April 25, 2003 Received: May 13, 2003
Dear Ms. Weaver:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
Indications for Use Statement
510(k) Number (if known): K034110
Device Name: VITEK 2® Gram Positive Linezolid (1ug/ml) for Streptococcus pneumoniae
Indications for Use:
VITEK 2® Gram Positive Linezolid for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococcus pneumoniae. It is intended for use with the VITEK 2® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Freddie L. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KO3 1410
for Prescription Use only