(57 days)
N50510/S135
Not Found
No
The description focuses on standard microbiological techniques and automated reading of growth, with no mention of AI/ML algorithms for interpretation or analysis.
No
The device is described as a "laboratory aid" for antimicrobial susceptibility testing, which provides MIC values and interpretive categories. It does not directly treat or diagnose diseases but rather provides information used in a laboratory setting to inform treatment decisions.
Yes
This device is designed for antimicrobial susceptibility testing, which helps determine the effectiveness of antimicrobial agents against specific bacteria. This information is crucial for guiding treatment decisions and is therefore a diagnostic aid.
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 "intended for use with the VITEK® 2 System as 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 a specific antibiotic).
- Device Description: The description details how the device works by testing bacterial isolates in a laboratory setting using a microdilution methodology. This is a standard technique for in vitro diagnostic testing.
- Intended User / Care Setting: It is described as a "laboratory aid," further reinforcing its use in a clinical laboratory setting for diagnostic purposes.
- Performance Studies: The performance studies compare the device's results to a "reference method" (NCCLS microbroth dilution), which is typical for validating the accuracy of an IVD.
The core function of the device is to analyze a biological sample (bacterial isolate) in vitro to provide information that aids in the diagnosis and treatment of a patient's condition (determining which antibiotic will be effective against the infection). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Positive Moxifloxacin 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 (comma separated list FDA assigned to the subject device)
LON
Device Description
VITEK 2 Gram Positive Moxifloxacin 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
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
The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae by companing 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 Moxifloxacin for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the NCCLS reference microbroth dilution method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; guidance for Industry and FDA. Issued February 5, 2003.
VITEK 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae demonstrated acceptable performance of 99.6% overall Essential Agreement when compared to the microbroth dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: 99.6%
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/S135
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.”
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Image /page/0/Picture/0 description: The image shows the date AUG 13 2003. Below the date is a logo for BIOMERIEUX. The logo is a circle that is half black and half white with lines.
K03/865-
p. 39
510(k) SUMMARY
VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae
A. Submitter 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: | June 6, 2003 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Moxifloxacin for |
| Streptococcus pneumoniae | |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, | |
| 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GP Moxifloxacin for Streptococcus |
| pneumoniae | |
| C. Predicate Device: | VITEK® 2 Streptococcus pneumoniae |
| Susceptibility Test for Ceftriaxone (N50510/S135) |
D. 510(k) Summary:
VITEK 2 Gram Positive Moxifloxacin 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
1
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 Moxifloxacin for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the NCCLS reference microbroth dilution method, as defined in the Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; guidance for Industry and FDA. Issued February 5, 2003.
The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Moxifloxacin 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 Moxifloxacin for Streptococcus pneumoniae by companing its performance with the NCCLS microbroth dilution reference method. VITEK 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae demonstrated acceptable performance of 99.6% overall Essential Agreement when compared to the microbroth dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
AUG 1 3 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
K031865 Re: Trade/Device Name: VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae (0.25-2 mcg/ml) 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: June 6, 2003 Received: June 18, 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, listing 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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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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Indications for Use Statement
510(k) Number (if known):
Device Name: VITEK® 2 Gram Positive Moxifloxacin for Streptococcus pneumoniae, 0.25 - 2 mcg/ml
Indications for Use:
VITEK® 2 Gram Positive Moxifloxacin 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)
Neesa 8/12/03
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
✓
Perscription use -
(Per 21 CFR 801.109)
KO3186 2 510(k)_
Over the - Counter un