(91 days)
N50510/S139
Not Found
No
The description focuses on automated optical readings and standard microbiological methods for determining MIC and susceptibility categories. There is no mention of AI/ML algorithms being used for interpretation or analysis.
No.
The device is an in vitro diagnostic (IVD) test used to determine the susceptibility of an organism to antimicrobial agents, not to treat or prevent a disease or condition in a patient.
Yes
The device is an in vitro test used to determine the susceptibility of Streptococcus pneumoniae to antimicrobial agents, which is a diagnostic purpose. It helps identify how effective an antimicrobial agent will be against a specific bacterial strain, informing treatment decisions.
No
The device description clearly outlines hardware components like the VITEK 2 System, AST panels, optical reader/incubator, and an optical system, which are integral to the device's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states it is "intended for use with the VITEK® 2 System in clinical laboratories as an in vitro test to determine the susceptibility of Streptococcus pneumoniae to antimicrobial agents." The phrase "in vitro test" is a key indicator of an IVD.
- Device Description: The description details how the device works by testing organism growth in a panel containing antimicrobial agents. This process is performed outside of the living organism, which is the definition of "in vitro."
- Clinical Laboratories: The intended user setting is clinical laboratories, which are where IVD tests are typically performed.
Therefore, based on the provided information, the VITEK® 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VITEK® 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin is intended for use with the VITEK® 2 System in clinical Laboratories as an in vitro test to determine the susceptibility of Streptococcus pneumoniae to antimicrobial agents. The antimicrobial presented in the VITEK® 2 AST panel is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
The VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin is intended for use with the VITEK® 2 System in clinical laboratories as an in vitro test to intendou the susceptibility of Streptococcus pneumoniae to antimicrobial agents. The antimicrobial presented in the VITEK® 2 AST panel is in concentrations equivalent by afficacy to standard method concentrations in mcg/ml. The AST panels are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) my microdilution methodology.
The VITEK 2 system automatically fills the AST panels with a standardized organism suspension. The organism suspension may either be prepared automatically by the VITEK 2 or prepared manually. The filled AST panels are automatically sealed and loaded into the optical reader/incubator. Temperature is monitored and controlled throughout the incubation cycle. Organism growth in the test panel is continually monitored by the optical system. Optical readings are transformed by the VITEK 2 System into antimicrobial MIC's and category (Sensitive/Intermediate/Resistant) interpretations.
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
clinical laboratories
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 the VITEK 2 AST Panel by comparing its performance with an NCCLS frozen reference panel. Challenge strains were compared to an "Expected Result".
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial susceptibility Devices", dated March 8, 2000. The Premarket Notification (510[k]) presents data in support of the VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin. 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 the VITEK 2 AST Panel by comparing its performance with an NCCLS frozen reference panel. Challenge strains were compared to an "Expected Result". The VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin demonstrated acceptable performance of 99.8% overall Essential Agreement with automatic dilution when compared to the frozen reference panel. Reproducibility testing demonstrated acceptable reproducibility with both automatic and manual dilution methods. Quality Control demonstrated acceptable results for VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99.8% overall Essential 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.
N50510/S139
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
KO20871
MAR 2 9 2002
510(k) SUMMARY
VITEK® 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Nancy Weaver, Staff Regulatory/Clinical |
| Affairs Specialist | |
| Phone Number: | 314-731-8695 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | November 19, 2001 |
| B. Device Name: | VITEK 2 Gram Positive AST Panel for |
| Streptococcus pneumoniae: Levofloxacin | |
| Trade Name: | VITEK® 2 Levofloxacin |
| Common Name: | Levofloxacin (LEV) |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, | |
| 21 CFR 866.1645 | |
| C. Predicate Device: | VITEK ® 2 Gram Positive AST Panel for |
| Streptococcus pneumoniae: | |
| Trimethoprim/Sulfamethoxazole (N50510/S139) |
D. 510(k) Summary:
The VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin is intended for use with the VITEK® 2 System in clinical laboratories as an in vitro test to intendou the susceptibility of Streptococcus pneumoniae to antimicrobial agents. The antimicrobial presented in the VITEK® 2 AST panel is in concentrations equivalent by afficacy to standard method concentrations in mcg/ml. The AST panels are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) my microdilution methodology.
The VITEK 2 system automatically fills the AST panels with a standardized organism suspension. The organism suspension may either be prepared automatically by the VITEK 2 or prepared manually. The filled AST panels are automatically sealed and loaded into the optical reader/incubator. Temperature is monitored and controlled throughout the incubation cycle. Organism growth in the test panel is continually monitored by the optical system. Optical readings are transformed by the VITEK 2
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510(k) Summary (continued)
System into antimicrobial MIC's and category (Sensitive/Intermediate/Resistant) interpretations.
The VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document ""Guidance on Review Criteria for Assessment of Antimicrobial susceptibility Devices", dated March 8, 2000. The Premarket Notification (510[k]) presents data in support of the VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin.
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 the VITEK 2 AST Panel by comparing its performance with an NCCLS frozen reference panel. Challenge strains were compared to an "Expected Result". The VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin demonstrated acceptable performance of 99.8% overall Essential Agreement with automatic dilution when compared to the frozen reference panel.
Reproducibility testing demonstrated acceptable reproducibility with both automatic and manual dilution methods.
Quality Control demonstrated acceptable results for VITEK 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nancy Weaver Staff Regulatory/Clinical Affairs Specialist bioMerieux, Inc. 595 Anglum Road, Hazelwood, Missouri 63042-2320
MAR 2 9 2002
Re: K020871
Trade/Device Name: VITEK® 2 Gram Positive Antimicrobial Susceptibility Test Panel for Streptococcus pneumoniae: Levofloxacin 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: November 19, 2001 Received: December 28, 2001
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): _ K 02087/
Device Name: VITEK® 2 Gram Positive AST Panel for Streptococcus pneumoniae: Levofloxacin
Indications for Use:
The VITEK® 2 Gram Positive AST Panel for Streptococcus pneumoniae: The VITERS E Granded for use with the VITEK® 2 System in clinical Levonoxacin is intended for abo flet mine the susceptibility of Streptococcus laboratories as an in throughts. The antimicrobial panel presented in phoumations as as T card is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
PRESCRIPTION USE X
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woodyk Dubrez
Division of Clinical Laboratory Devices 510(k) Number_