(268 days)
Not Found
No
The description focuses on a microdilution technique and automated monitoring of bacterial growth, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic (IVD) test, not a therapeutic device. It is intended to help determine the susceptibility of Streptococcus species to antimicrobial agents, aiding in diagnostic processes rather than directly providing therapy.
Yes
The device, VITEK® 2 AST-Streptococcus Cefotaxime, is intended for antimicrobial susceptibility testing of Streptococcus spp. to determine in vitro susceptibility to antimicrobial agents. This provides information used in the diagnosis and treatment of infections, making it a diagnostic device.
No
The device description explicitly details a physical AST card with wells containing media and antibiotics, which is a hardware component. The system also involves automated or manual filling, sealing, and incubation, indicating a hardware-dependent process.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "designed for antimicrobial susceptibility testing of Streptococcus spp." 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." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a test performed on a sample (bacterial isolate) outside of the body, using a specific card containing reagents (antibiotics and culture media). This is characteristic of an in vitro test.
- Care Setting: The intended user is listed as "clinical laboratories," which are common settings for performing in vitro diagnostic tests.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard in vitro diagnostic technique for antimicrobial susceptibility testing.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the collection, preparation, and examination of specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease. In this case, the device is examining bacterial isolates from potentially infected individuals to determine their susceptibility to antibiotics, which aids in guiding treatment.
N/A
Intended Use / Indications for Use
VITEK® 2 AST-Streptococcus Cefotaxime is designed for antimicrobial susceptibility testing of Streptococcus spp. 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 AST- Streptococcus Cefotaxime is a quantitative test. Cefotaxime 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:
Streptococcus pneumoniae
Streptococcus pyogenes (Group A beta-hemolytic streptococci)*
Streptococcus spp. (Viridans group streptococci)
*The VITEK® 2 Streptococus Susceptibility Card also reports the susceptibility of the following additional organisms as listed on the FDA Susceptibility Test Interia website (STIC): Streptococcus spp. B-Hemolytic Group (other than S. pyogenes).
The VITEK® 2 Streptococcus Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.
Product codes (comma separated list FDA assigned to the subject device)
LON, LTW, LTT
Device Description
The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh(1) and Gerlach(0). The VITEK @ 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3).
Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. 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
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 contemporary and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of AST-ST Cefotaxime by comparing its performance with the CLSI broth microdilution reference method incubated at 20-24 hrs (i.e. Streptococcus). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
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 AST-ST Cefotaxime. An external evaluation was conducted with contemporary and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of AST-ST Cefotaxime by comparing its performance with the CLSI broth microdilution reference method incubated at 20-24 hrs (i.e. Streptococcus). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
The VITEK® 2 AST-ST Cefotaxime (≤0.125 - ≥8 µg/mL) demonstrated acceptable performance as presented in Table 2 below:
Cefotaxime:
Streptococcus pneumoniae (meningitis): %EA (346/351) 98.6; %CA (314/351) 89.5; VME (0/54) 0.0; ME (2/243) 0.8; mE (35/351) 10.0
Streptococcus pneumoniae (non-meningitis): %EA (346/351) 98.6; %CA (315/351) 89.7; VME (0/23) 0.0; ME (1/297) 0.3; mE (35/351) 10.0
Streptococcus pyogenes (Group A beta-Hemolytic GroupNS: %EA (310/310) 100.0; %CA (310/310) 100.0; VME (0/0) 0.0; ME (0/310) 0.0; % Reproducibility 100.0
Streptococcus spp. beta-Hemolytic Group (other than S. pyogenes) NS: %EA (554/554) 100.0; %CA (554/554) 100.0; VME (0/0) 0.0; ME (0/554) 0.0
Streptococcus spp. Viridans Group: %EA (397/408) 97.3; %CA (396/408) 97.1; VME (0/12) 0.0; ME (0/381) 0.0; mE (12/408) 2.9
The VITEK 2 Cefotaxime MC values for Streptococus spp Viridans Group ended to be at least one than the reference method and may contibute to the occurrence of very major errors.
Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA), Category Agreement (CA), Very Major Error (VME), Major Error (ME), minor Error (mE), Reproducibility.
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-Streptococcus Cefotaxime (≤0.125 - ≥8 µg/mL) (K121863)
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
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October 28, 2021
bioMérieux, Inc Cherece L Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri, 63042 USA.
Re: K210287
Trade/Device Name: VITEK 2 AST- Streptococcus Cefotaxime (8 ug/mL) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON, LTW, LTT Dated: January 29, 2021 Received: February 2, 2021
Dear Cherece Jones:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
VITEK® 2 AST- Streptococcus Cefotaxime (≤0.125 - ≥8 µg/mL)
Indications for Use (Describe)
VITEK® 2 AST-Streptococcus Cefotaxime is designed for antimicrobial susceptibility testing of Streptococcus spp. 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 AST- Streptococcus Cefotaxime is a quantitative test. Cefotaxime 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:
Streptococcus pneumoniae Streptococcus pyogenes (Group A beta-hemolytic streptococci)* Streptococcus spp. (Viridans group streptococci)
*The VITEK® 2 Streptococus Susceptibility Card also reports the susceptibility of the following additional organisms as listed on the FDA Susceptibility Test Interia website (STIC): Streptococcus spp. B-Hemolytic Group (other than S. pyogenes).
The VITEK® 2 Streptococcus Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of S. pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------- | ------------------------------------------------------------ |
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3
Image /page/3/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle that is split into two halves. The top half is blue and contains the word "BIOMÉRIEUX" in white, sans-serif font. The bottom half of the circle is yellow and green.
510(k) SUMMARY
VITEK® 2 AST-Streptococcus Cefotaxime (≤0.125 - ≥8 µg/mL)
A. 510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Cherece L. Jones |
| Staff Regulatory Affairs Specialist | |
| Phone Number: | 314 -731-8684 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | January 29, 2021 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST- Streptococcus Cefotaxime (≤0.125 - ≥8 |
| µg/mL) | |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code: LON | |
| Common Name: | VITEK® 2 AST-ST Cefotaxime (≤0.125 - ≥8 µg/mL) |
| C. Predicate Device: | VITEK® 2 AST-Streptococcus Cefotaxime (≤0.125 - |
| ≥8 µg/mL) (K121863) |
D. Device Description:
The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh(1) and Gerlach(0). The VITEK @ 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3).
4
Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle on top and a yellow-green circle on the bottom, separated by a white line. The word "BIOMÉRIEUX" is written in white letters in the center of the blue circle.
Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. 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.
E. Substantial Equivalence Information:
The similarities and differences of the VITEK® 2 AST- Streptococcus Cefotaxime (≤0.125 - ≥8 ug/mL) when compared to the predicate device, VITEK® 2 AST-Streptococcus Cefotaxime (Active in vitro and in clinical
infections:
Streptococcus pneumoniae
Streptococcus pyogenes (Group A
beta-hemolytic streptococci)*
Streptococcus spp. (Viridans group
streptococci)
*The VITEK® 2 Streptococcus
Susceptibility Card also reports the
susceptibility of the following
additional organisms as
listed on the FDA Susceptibility Test
Interpretative Criteria website
(STIC): Streptococcus spp. ß-
Hemolytic Group (other than S.
pyogenes ).
The VITEK® 2 Streptococcus
Susceptibility Card is intended for
use with the VITEK® 2 Systems in
clinical laboratories as an in vitro test
to determine the susceptibility of S.
pneumoniae , beta-hemolytic
Streptococcus , and Viridans
Streptococcus to antimicrobial agents
when used as instructed | Cefotaxime has been shown to be
active against most strains of the
microorganism listed below, according
to the FDA label for this antimicrobial.
Active in vitro and in clinical
infections:
Streptococcus pneumoniae ,
Streptococcus pyogenes (Group A
beta-hemolytic streptococci),
Streptococcus spp.
The VITEK® 2 Antimicrobial
Susceptibility Test (AST) is intended
to be used with the VITEK® 2 and
VITEK 2 Compact 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
agalactiae , and S. pneumoniae . |
F. Performance Overview and Conclusion:
VITEK® 2 AST-ST Cefotaxime (≤0.125 - ≥8 µg/mL) 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).
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Image /page/6/Picture/0 description: The image shows the logo for bioMérieux. The logo consists of a blue circle on top of a green and yellow circle. The word "BIOMÉRIEUX" is written in white letters in the center of the blue circle.
The Premarket Notification (510|k]) presents data in support of VITEK® 2 AST-ST Cefotaxime. An external evaluation was conducted with contemporary and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of AST-ST Cefotaxime by comparing its performance with the CLSI broth microdilution reference method incubated at 20-24 hrs (i.e. Streptococcus). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
The VITEK® 2 AST-ST Cefotaxime (≤0.125 - ≥8 µg/mL) demonstrated acceptable performance as presented in Table 2 below:
| Antimicrobial | Antimicrobial
Code | Antibiotic
Version | Bp1 | Comment2 | Essential Agreement Category | | | | Category Agreement | | | | % Repr du cibilit |
|---------------|-----------------------|-----------------------|---------------|------------------------------------------------------------------------------------------|------------------------------|-----|-----|-----|--------------------|---------------|----------------|------------------|-------------------|
| | | | | | % Error | | | | % Error | | | | |
| | | | | | %EA | VME | ME | mE | %CA | VME | ME | mE | |
| Cefotaxime* | CTX | (ctx01n) | FDA
(CLSI) | #, E
Streptococcus
pneumoniae
(meningitis) | (346/351)
98.6 | N/A | N/A | N/A | (314/351)
89.5 | (0/54)
0.0 | (2/243)
0.8 | (35/351)
10.0 | |
| | | | | #, E
Streptococcus
pneumoniae
(non -
meningitis) | (346/351)
98.6 | N/A | N/A | N/A | (315/351)
89.7 | (0/23)
0.0 | (1/297)
0.3 | (35/351)
10.0 | |
| | | | | #, E
Streptococcus
pyogenes
(Group A β-
Hemolytic
GroupNS | (310/310)
100.0 | N/A | N/A | N/A | (310/310)
100.0 | (0/0)
0.0 | (0/310)
0.0 | N/A | 100.0 |
| | | | | #, E
Streptococcus
spp. β-
Hemolytic
Group (other
than S.
pyogenes) NS | (554/554)
100.0 | N/A | N/A | N/A | (554/554)
100.0 | (0/0)
0.0 | (0/554)
0.0 | N/A | |
| | | | | #, E
Streptococcus
spp. Viridans
Group | (397/408)
97.3 | N/A | N/A | N/A | (396/408)
97.1 | (0/12)
0.0 | (0/381)
0.0 | (12/408)
2.9 | |
Toble 21 VITEV® 2 AST ST Cafatoximo Porformonea
The VITEK 2 Cefotaxime MC values for Streptococus spp Viridans Group ended to be at least one than the reference method and may contibute to the occurrence of very major errors.
NS - The current absence of resistant isolates defining any results other than susceptible. Isolates pieding MC results suggestive of Nonsuceptible category should be submitted to a reference laboratory for further testing.
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Image /page/7/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with the top half being blue and the bottom half being yellow-green. The word "BIOMÉRIEUX" is written in white letters in the center of the blue portion of the circle.
*For specific information regarding succession and associaed test methods and quality contriss standards recognized by FDA for his drug, pleas sec https://www.fda.gov/STIC
Kev: # = US Food and Drug Administration 510(k) cleared E = External performance data
Quality Control demonstrated acceptable results.
G. Limitations:
The ability of the AST card to detect resistance with the following combination(s) is unknown because resistant strains were either not available or an insufficient number were encountered at the time of comparative testing:
- Cefotaxime (ctx01n): Streptococcus pyogenes (Group A ß-hemolytic streptococci) and ● Streptococcus spp ß-Hemolytic Group (other than S. pyogenes)
H. References:
- MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic 1. Sensitivity Testing in the Clinical laboratory, Journal of Laboratory Clinical Medicine, 72:685-687, 1968.
- Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. Current Techniques for 2. Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL, 1974.
- Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, 3. Philadelphia, PA, 1976.