(90 days)
Not Found
No
The description focuses on the microdilution technique and automated monitoring of bacterial growth, with no mention of AI or ML algorithms for analysis or interpretation.
No.
This device is an in vitro diagnostic (IVD) tool designed for antimicrobial susceptibility testing, which provides information to aid in the determination of in vitro susceptibility, not direct therapy.
Yes
Explanation: The device is designed for "antimicrobial susceptibility testing of Streptococcus species" and is intended "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This directly relates to diagnosing which antimicrobial agents will be effective against a particular disease-causing microorganism.
No
The device description clearly states it is based on a microdilution technique using physical cards with wells containing antibiotics and culture media, which are then processed by the VITEK® 2 Systems (hardware). This is not a software-only device.
Based on the provided text, the device is indeed 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 "in vitro susceptibility testing of Streptococcus species" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory test method (microdilution minimum inhibitory concentration technique) performed on a sample (bacterial or yeast isolate) outside of the body.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard laboratory technique for in vitro testing.
- Intended User / Care Setting: The device is intended for use in "clinical laboratories," which are the typical settings for performing IVD tests.
The entire context of the document describes a test performed on biological samples in a laboratory setting to provide information for clinical decision-making, which aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Streptococcus species 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 Streptococcus Penicillin is a quantitative test. Penicillin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections: Beta hemolytic Streptococci groups C and G Streptococcus pyogenes Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae
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 Sireptococcus 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, LTT, LTW
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(2). 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 bacterial or yeast 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.
VITEK® 2 Streptococcus Penicillin has the following concentrations in the card: 0.06, 0.12, 0.5, and 2ug/mL (equivalent standard method concentration by efficacy in ug/mL).
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, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 Streptococcus Penicillin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK® 2 Streptococcus Penicillin demonstrated substantially equivalent performance when compared with the 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).
Performance data is available for:
- Streptococcus pneumoniae (non-meningitis) (N=350)
- Streptococcus pneumoniae (oral) (N=350)
- Streptococcus pneumoniae (meningitis) (N=350)
- Streptococcus Viridans group (except Streptococcus pneumoniae) (N=391)
- Beta-hemolytic Streptococcus (N=833)
Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement (EA)
- Streptococcus pneumoniae (non-meningitis): 97.7% (342/350)
- Streptococcus pneumoniae (oral): 97.7% (342/350)
- Streptococcus pneumoniae (meningitis): 97.7% (342/350)
- Streptococcus Viridans group (except Streptococcus pneumoniae): 98.5% (385/391)
- Beta-hemolytic Streptococcus: 100% (833/833)
Category Agreement (CA)
- Streptococcus pneumoniae (non-meningitis): 92.3% (323/350)
- Streptococcus pneumoniae (oral): 89.7% (314/350)
- Streptococcus pneumoniae (meningitis): 97.7% (342/350)
- Streptococcus Viridans group (except Streptococcus pneumoniae): 94.1% (368/391)
- Beta-hemolytic Streptococcus: 100% (833/833)
Very Major Error (VME)
- Streptococcus pneumoniae (non-meningitis): 0.0% (0/0)
- Streptococcus pneumoniae (oral): 0.0% (0/94)
- Streptococcus pneumoniae (meningitis): 1.2% (2/161)
- Streptococcus Viridans group (except Streptococcus pneumoniae): 0.0% (0/15)
- Beta-hemolytic Streptococcus: 0.0% (0/0)
Major Error (ME)
- Streptococcus pneumoniae (non-meningitis): 0.0% (0/304)
- Streptococcus pneumoniae (oral): 0.0% (0/189)
- Streptococcus pneumoniae (meningitis): 3.2% (6/189)
- Streptococcus Viridans group (except Streptococcus pneumoniae): 0.0% (0/268)
- Beta-hemolytic Streptococcus: 0.0% (0/833)
Minor Error (mE)
- Streptococcus pneumoniae (non-meningitis): 7.7% (27/350)
- Streptococcus pneumoniae (oral): 10.3% (36/350)
- Streptococcus pneumoniae (meningitis): N/A
- Streptococcus Viridans group (except Streptococcus pneumoniae): 5.9% (23/391)
- Beta-hemolytic Streptococcus: N/A
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side, there is a symbol representing the Department of Health & Human Services - USA. To the right, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, with 'ADMINISTRATION' written in a smaller font size below.
October 23, 2023
bioMerieux, Inc Jared Bronson Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K232201
Trade/Device Name: VITEK 2 AST-Streptococcus Penicillin (=8 µg/mL), VITEK 2 Streptococcus Penicillin (=8 ug/mL), VITEK 2 Streptococcus Penicillin 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: July 20, 2023 Received: July 25, 2023
Dear Jared Bronson:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S
Ribhi Shawar, Ph.D. (ABBM) Branch Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232201
Device Name
VITEK® 2 Streptococcus Penicillin (≤0.06 - ≥8 µg/mL)
Indications for Use (Describe)
VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Streptococcus species 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 Streptococcus Penicillin is a quantitative test. Penicillin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections: Beta hemolytic Streptococci groups C and G Streptococcus pyogenes Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae
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 Sireptococcus 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo is a circle with a blue upper half and a gradient yellow-to-green lower half. The company name, "BIOMÉRIEUX", is written in white, sans-serif font across the center of the blue portion of the circle.
510(k) SUMMARY
VITEK® 2 Streptococcus Penicillin (≤ 0.06 -> 8 µg/mL)
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jared Bronson |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-201-8799 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | June 12, 2023 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Streptococcus Penicillin (≤0.06 - ≥8 µg/mL) |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code: LON, LTT, LTW | |
| Common Name: | VITEK® 2 Streptococcus Penicillin |
| C. Predicate Device: | VITEK® 2 Streptococcus Penicillin (≤0.06 - ≥8 µg/mL) |
| (K112000) |
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(2). 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
4
Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with the top half in dark blue and the bottom half in yellow-green. The word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue portion of the circle.
portions of a specific antibiotic combined with culture media. The bacterial or yeast 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.
VITEK® 2 Streptococcus Penicillin has the following concentrations in the card: 0.06, 0.12, 0.5, and 2ug/mL (equivalent standard method concentration by efficacy in ug/mL).
E. Substantial Equivalence Information:
The similarities and differences of the VITEK® 2 Streptococcus Penicillin when compared to the predicate device, VITEK® 2 Streptococcus Penicillin (K112000), are described in the following table. There is no difference between the new device and the predicate device.
| Device and Predicate
| Device(s): | Device: | Predicate Device: K112000 |
|---|---|---|
| Device Trade Name | VITEK® 2 Streptococcus Penicillin | VITEK® 2 Streptococcus Penicillin |
| General Device Characteristic Similarities | ||
| Intended Use/Indications | ||
| for Use | VITEK® 2 Streptococcus Penicillin | |
| is designed for antimicrobial | ||
| susceptibility testing of Gram- | ||
| positive microorganisms 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 | ||
| Streptococcus Penicillin is a | ||
| quantitative test. |
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
Streptococcus pneumoniae, beta-
hemolytic Streptococcus, and | VITEK® 2 Streptococcus Penicillin is
designed for antimicrobial
susceptibility testing of Gram-positive
microorganisms 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 Gram Positive Penicillin is a
quantitative test.
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
Streptococcus pneumoniae, beta-
hemolytic Streptococcus, and Viridans
Streptococcus to antimicrobial agents |
| | | |
| Viridans Streptococcus to
antimicrobial agents when used as
instructed. | when used as instructed. | |
| Penicillin has been shown to be
active against most strains of the
microorganisms listed below,
according to the FDA label for this
antimicrobial. | Penicillin has an antimicrobial activity
against the microorganisms listed
below, according to the FDA label for
this antimicrobial. | |
| Active both in vitro and in clinical
infections:
Beta hemolytic Streptococci groups
C and G
Streptococcus pyogenes
Streptococcus agalactiae
Streptococcus viridans group
Streptococcus pneumoniae | Active in vitro and in clinical
infections:
Beta hemolytic Streptococci groups C
and G
Streptococcus pyogenes
Streptococcus agalactiae
Streptococcus viridans group
Streptococcus pneumoniae | |
| Test Methodology | Automated quantitative antimicrobial
susceptibility test for use with the
VITEK® 2 and VITEK® 2 Compact
Systems to determine the in vitro
susceptibility of microorganisms | |
| | Same | |
| Antimicrobial Agent | Penicillin | |
| | Same | |
| Inoculum | Saline suspension of organism | |
| | Same | |
| Test Card | Streptococcus (AST-ST) Susceptibility
Card | |
| | Same | |
| Analysis Algorithms | Discriminant Analysis | |
| | Same | |
| Instrument | VITEK® 2 and VITEK® 2 Compact
Systems | |
| | Same | |
| Concentrations | 0.06, 0.12, 0.5, 2 | |
| | Same | |
| General Device Characteristic Differences | | |
| Breakpoints | S. pneumoniae (non-meningitis) [≤2 / 4 / ≥8] S. pneumoniae (meningitis) [≤0.06/ - /≥0.12] Viridans Streptococci [≤0.12/0.25-2/≥4] Beta-hemolytic Streptococcus [≤0.12/-/-] S. pneumoniae (oral/non-meningitis) [≤0.06/0.12-1/≥2] | |
| | S. pneumoniae (non-meningitis) [≤2 / 4 / ≥8] S. pneumoniae (meningitis) [≤0.06/ - /≥0.12] Viridans Streptococci [≤0.12/0.25-2/≥4] Beta-hemolytic Streptococcus [≤0.12/-/-] S. pneumoniae (oral) [none] | |
Table 1: Substantial Equivalence
5
Image /page/5/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a circle that is split into two halves. The top half is a dark blue color, and the bottom half is a gradient of yellow to green. The company name, "BIOMÉRIEUX", is written in white letters in the center of the blue half of the circle.
VITEK® 2 Streptococcus Penicillin
6
Image /page/6/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 dark blue and contains the word "BIOMÉRIEUX" in white, sans-serif font. The bottom half is yellow, fading into green.
F. Intended Use:
VITEK® 2 Streptococcus Penicillin is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Streptococcus Penicillin is a quantitative test. Penicillin has been shown to be active against the microorganisms listed below, according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections: Beta hemolytic Streptococci groups C and G Streptococcus pyogenes Streptococcus agalactiae Streptococcus viridans group Streptococcus pneumoniae
The VITEK® 2 Streptococcus Penicillin Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Streptococcus pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.
G. Performance Overview and Conclusion:
VITEK® 2 Streptococcus Penicillin demonstrated substantially equivalent performance when compared with the 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).
The Premarket Notification (PMA) presents data in support of VITEK® 2 Streptococcus Penicillin. 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 Penicillin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
VITEK® 2 Streptococcus Penicillin (≤0.06 - ≥8 µg/mL) demonstrated acceptable performance as presented in Table 2 below:
Table 2: VITEK® 2 Streptococcus Penicillin Performance
7
Image /page/7/Picture/0 description: The image shows the logo for bioMérieux, a French multinational biotechnology company. The logo consists of a circle divided into two sections. The top section is a dark blue color and contains the company name "BIOMÉRIEUX" in white, sans-serif font. The bottom section is a gradient of yellow to green.
VITEK® 2 Streptococcus Penicillin
| Antimicrobi
al | Antimic
robial
Code | Antibio
tic
Version | Bp1 | Comment | Essential Agreement Category | | | | Category Agreement | | | |
|-------------------|---------------------------|---------------------------|---------------|-----------------------------------------------------------------------------------------|------------------------------|-----|-----|-----|--------------------|-----------------|-----------------|-------------------|
| | | | | | %EA | VME | ME | mE | %CA | VME | ME | mE |
| Penicillin | P | (p01n) | CLSI
(FDA) | #, E Strepto-
coccus pneu-
moniae (non-
meningitis). | (342/350)
97.7 | N/A | N/A | N/A | (323/350)
92.3 | (0/0)
0.0 | (0/304)
0.0 | (27/350)
7.7 |
| | | | | #, E Strepto-
coccus pneu-
moniae (oral). | (342/350)
97.7% | N/A | N/A | N/A | (314/350)
89.7% | (0/94)
0.0% | (0/189)
0.0% | (36/350)
10.3% |
| | | | | #, E Strepto-
coccus pneu-
moniae (menin
gitis). | (342/350)
97.7% | N/A | N/A | N/A | (342/350)
97.7% | (2/161)
1.2% | (6/189)
3.2% | N/A |
| | | | | #, E Strepto
coccus Viridan
s group (except
Strepto
coccus pneum
oniae). | (385/391)
98.5% | N/A | N/A | N/A | (368/391)
94.1% | (0/15)
0.0% | (0/268)
0.0% | (23/391)
5.9% |
| | | | | #, E Beta-
hemoly-
tic Strepto-
coccus | (833/833)
100% | N/A | N/A | N/A | (833/833)
100% | (0/0)
0.0% | (0/833)
0.0% | N/A |
Reproducibility and Quality Control demonstrated acceptable results.
8
Image /page/8/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with two distinct color sections. The top half of the circle is a dark blue color, and the word "BIOMÉRIEUX" is written in white, sans-serif font in the center of the blue section. The bottom half of the circle transitions from yellow to green.
H. References:
-
- MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic 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 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.