(105 days)
Not Found
No
The description focuses on automated microbial growth monitoring and comparison to standard methods, with no mention of AI/ML algorithms for interpretation or analysis.
No.
This device is for in vitro diagnostic testing to determine the susceptibility of bacteria to antimicrobial agents, which aids in treatment decisions but does not directly treat a patient.
Yes
The device is designed for antimicrobial susceptibility testing and determines the in vitro susceptibility of bacterial isolates to antimicrobial agents, providing results that aid in clinical decision-making regarding treatment.
No
The device description clearly outlines physical components like "VITEK® 2 AST-ST Cards" and the "VITEK® 2 and VITEK® 2 Compact Systems" which are instruments that perform physical processes like filling, sealing, and incubating. This indicates it is a hardware-based system with associated software, not a software-only device.
Based on the provided text, 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 agalactiae and Streptococcus pyogenes" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates testing performed in vitro (outside the body) on biological samples (bacterial isolates) to provide information for diagnosis or treatment decisions.
- Device Description: The description details a process of testing bacterial isolates diluted in saline and placed in a card with antimicrobial agents. This is a classic in vitro diagnostic methodology.
- Performance Studies: The performance studies compare the device's performance to a "reference method" (CLSI Interpretive Criteria), which is typical for validating an IVD.
- Predicate Device: The mention of a predicate device (K080201; VITEK® 2 Gram Positive Inducible Clindamycin Resistance) which is also an IVD, further supports this classification.
The core function of the device is to test biological samples (bacterial isolates) in vitro to determine their susceptibility to antimicrobial agents, which directly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Streptococcus Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Streptococcus agalactiae and Streptococcus pyogenes. VITEK® 2 Streptococcus Inducible Clindamycin Resistance 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.
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 bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and yeast.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
The antimicrobial presented in VITEK® 2 AST-ST Cards are 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, seas and places the card into the incubator/reader. The VITE variet 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
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, as well as a set of challenge strains.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Premarket Notification (510[k]) presents data in support of VITEK® 2 Streptococcus Inducible Clindamycin Resistance. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 Streptococcus Inducible Clinidamycin Resistance by comparing its performance with the CLSI Interpretive Criteria incubated at 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 Streptococcus Inducible Clindamycin Resistance demonstrated acceptable performance of 99.2% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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
KIN 909
Image /page/0/Picture/1 description: The image shows the logo for bioMerieux. The logo consists of a stylized globe with half of it shaded with horizontal lines and the other half shaded black. The company name "BIOMERIEUX" is written in a stylized font below the globe.
OCT 1 8 2011
510(k) SUMMARY
VITEK® 2 Streptococcus Inducible Clindamycin Resistance
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Nathan Hardesty |
| Senior Regulatory Affairs Specialist | |
| Phone Number: | 314 - 731-8666 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | June 30, 2011 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 Streptococcus Inducible Clindamycin Resistance |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code LON | |
| Common Name: | VITEK® 2 AST-ST Inducible Clindamycin Resistance |
| Predicate Device: | VITEK® 2 Gram Positive Inducible Clindamycin Resistance |
| (K080201) |
D. 510(k) Summary:
B.
C.
VITEK® 2 Streptococcus Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Streptococcus agalactiae & Streptococcus pyogenes. VITEK® 2 Streptococcus Inducible Clindamycin Resistance 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.
The antimicrobial presented in VITEK® 2 AST-ST Cards are 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, seas and places the card into the incubator/reader. The VITE variet 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.
bioMérieux, Inc.
595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 x: 314/731-8700 http://www.biomerieux-usa.com
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Page 159
VITEK® 2 Streptococcus Inducible Clindamycin Resistance demonstrated substantially equivalent performance when compared with the CLSI Interpretive Criteria, 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 Streptococcus Inducible Clindamycin Resistance. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 Streptococcus Inducible Clinidamycin Resistance by comparing its performance with the CLSI Interpretive Criteria incubated at 24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 Streptococcus Inducible Clindamycin Resistance demonstrated acceptable performance of 99.2% overall category agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.
2
from 1/01/2008 to 8/2
' l ﺮﺓ ﺍﻟﻤﺮﺍﺟﻊ
TPLC Detailed View
Product Code Manufacturer Class Regulation Device Classification Device Name Date Last Listed Not Listed
t listed
CDRH Gen Docs without Manufacturer (None)
ﺮ ، ﻣﺴﺮ
Premarket Reviews Completed (None)
Under Review, Withdrawn or Closed without Product Code (None)
Standards and Guidance (None)
MDR Summary (None)
MDR Analyst (None)
MDR Distribution by Brand - Death or Injury (None)
Patient Problems (None)
Patient Outcomes (None)
Device Problems (None)
Manufacturer Evaluation Results (None)
Manufacturer Evaluation Conclusions (None)
Recalls (None)
Inspections (None)
CDRH Gen Docs without Manufacturer (None)
Rad Health Reports (None)
Rad Health Correspondence (None)
Rad Health Adverse Events (None)
Rad Health EIRs (None)
http://bi.fda.gov/businessobjects/enterprise115/desktoplaunch/viewers/cdz_adv/report.jsp?... 8/25/2011
3
Image /page/3/Picture/0 description: The image shows a black and white image with some black shapes on a white background. The black shapes are scattered throughout the image. The shapes appear to be random and do not form any recognizable pattern.
data last refreshed on 08/25/2011 08:16 AM
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4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Druq Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
OCT 1 8 2011
bioMérieux, Inc. c/o Nathan Hardesty Sr. Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K111909
Trade/Device Name: VITEK® 2 Streptococcus Inducible Clindamycin Resistance Regulation Number: 21 CFR& 866.1645 Regulation Name: Short-Term Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LON Dated: October 17, 2011 Received: October 17, 2011
Dear Mr. Hardesty:
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 class II (Special Controls), 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
5
Page 2 – Nathan Hardesty
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): 长川|969
Device Name: VITEK® 2 Streptococcus Inducible Clindamycin Resistance
Indications For Use:
VITEK® 2 Streptococcus Inducible Clindamycin Resistance is designed for antimicrobial VITEK® 2 susceptibility testing of Streptococcus agalactiae and Streptococcus pyogenes. Streptococcus Inducible Clindamycin Resistance 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.
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 bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and yeast.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Luddeke Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111969
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