(90 days)
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.
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).
Here's a summary of the acceptance criteria and study details for the VITEK® 2 Streptococcus Penicillin device:
1. Acceptance Criteria and Reported Device Performance
The device performance is compared to the broth microdilution reference method. The key metrics are Essential Agreement (EA) and Category Agreement (CA), along with Very Major Errors (VME), Major Errors (ME), and Minor Errors (mE).
| Antimicrobial | Organism/Comment | Acceptance Criteria (Not explicitly stated as numerical, but implied to be "acceptable performance") | Reported Device Performance: Essential Agreement (EA) | Reported Device Performance: Category Agreement (CA) | Reported Device Performance: VME | Reported Device Performance: ME | Reported Device Performance: mE |
|---|---|---|---|---|---|---|---|
| Penicillin | Streptococcus pneumoniae (non-meningitis) | Acceptable performance | 97.7% (342/350) | 92.3% (323/350) | 0.0% (0/0) | 0.0% (0/304) | 7.7% (27/350) |
| Penicillin | Streptococcus pneumoniae (oral) | Acceptable performance | 97.7% (342/350) | 89.7% (314/350) | 0.0% (0/94) | 0.0% (0/189) | 10.3% (36/350) |
| Penicillin | Streptococcus pneumoniae (meningitis) | Acceptable performance | 97.7% (342/350) | 97.7% (342/350) | 1.2% (2/161) | 3.2% (6/189) | N/A (not applicable) |
| Penicillin | Streptococcus Viridans group (except Streptococcus pneumoniae) | Acceptable performance | 98.5% (385/391) | 94.1% (368/391) | 0.0% (0/15) | 0.0% (0/268) | 5.9% (23/391) |
| Penicillin | Beta-hemolytic Streptococcus | Acceptable performance | 100% (833/833) | 100% (833/833) | 0.0% (0/0) | 0.0% (0/833) | N/A (not applicable) |
The document states that the device "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)." This guidance document typically outlines specific numerical acceptance criteria for EA, CA, VME, ME, and mE, which are implicitly met by the reported percentages being considered "acceptable."
2. Sample Size Used for the Test Set and Data Provenance
The sample sizes for the test set are embedded within the "Reported Device Performance" column (e.g., 350 for Streptococcus pneumoniae (non-meningitis), 391 for Streptococcus Viridans group, 833 for Beta-hemolytic Streptococcus).
The data provenance is from "external evaluation... conducted with fresh and stock clinical isolates, as well as a set of challenge strains." This implies a combination of retrospective (stock clinical isolates) and prospective (fresh clinical isolates) data. The country of origin of the data is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth is established by the CLSI broth microdilution reference method, but details on expert involvement in this process (e.g., reading/interpreting the reference method results) are not mentioned.
4. Adjudication Method for the Test Set
This information is not explicitly provided in the document. The study compares the VITEK® 2 results to the CLSI broth microdilution reference method. Adjudication might be part of the standard CLSI method, but it is not detailed here for discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of an automated diagnostic device against a reference method, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The VITEK® 2 system is a "Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System," and its performance was evaluated against the CLSI broth microdilution reference method. This is an evaluation of the algorithm's output (MIC values and interpretive categories) without direct human intervention in the interpretation of the VITEK® 2 results.
7. The Type of Ground Truth Used
The type of ground truth used is the broth microdilution reference method, specifically the CLSI method incubated at 16-20 hours. This is typically considered the gold standard for antimicrobial susceptibility testing.
8. The Sample Size for the Training Set
The document does not explicitly state the sample size for the training set. The study describes "external evaluation" for performance, but it doesn't separate out a specific training set size for the VITEK® 2 algorithm itself.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for any training set was established, as it primarily focuses on the performance evaluation of the final device against a reference method. However, given that the device is an "Automated quantitative antimicrobial susceptibility test," it's highly probable that any internal training/development would have used an established reference method (like broth microdilution) to establish ground truth for algorithm development.
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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 (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=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).
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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
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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) |
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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 RoadHazelwood, MO 63042 |
| Contact Person: | Jared BronsonRegulatory 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 866.1645Fully Automated Short-Term Incubation CycleAntimicrobial Susceptibility SystemProduct 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
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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 PredicateDevice(s): | Device: | Predicate Device: K112000 |
|---|---|---|
| Device Trade Name | VITEK® 2 Streptococcus Penicillin | VITEK® 2 Streptococcus Penicillin |
| General Device Characteristic Similarities | ||
| Intended Use/Indicationsfor Use | VITEK® 2 Streptococcus Penicillinis designed for antimicrobialsusceptibility testing of Gram-positive microorganisms and isintended for use with the VITEK® 2and VITEK® 2 Compact Systems asa laboratory aid in the determinationof in vitro susceptibility toantimicrobial agents. VITEK® 2Streptococcus Penicillin is aquantitative test.The VITEK® 2 StreptococcusSusceptibility Card is intended foruse with the VITEK® 2 Systems inclinical laboratories as an in vitro testto determine the susceptibility ofStreptococcus pneumoniae, beta-hemolytic Streptococcus, and | VITEK® 2 Streptococcus Penicillin isdesigned for antimicrobialsusceptibility testing of Gram-positivemicroorganisms and is intended foruse with the VITEK® 2 and VITEK®2 Compact Systems as a laboratory aidin the determination of in vitrosusceptibility to antimicrobial agents.VITEK 2 Gram Positive Penicillin is aquantitative test.The VITEK® 2 StreptococcusSusceptibility Card is intended for usewith the VITEK® 2 Systems inclinical laboratories as an in vitro testto determine the susceptibility ofStreptococcus pneumoniae, beta-hemolytic Streptococcus, and ViridansStreptococcus to antimicrobial agents |
| Viridans Streptococcus toantimicrobial agents when used asinstructed. | when used as instructed. | |
| Penicillin has been shown to beactive against most strains of themicroorganisms listed below,according to the FDA label for thisantimicrobial. | Penicillin has an antimicrobial activityagainst the microorganisms listedbelow, according to the FDA label forthis antimicrobial. | |
| Active both in vitro and in clinicalinfections:Beta hemolytic Streptococci groupsC and GStreptococcus pyogenesStreptococcus agalactiaeStreptococcus viridans groupStreptococcus pneumoniae | Active in vitro and in clinicalinfections:Beta hemolytic Streptococci groups Cand GStreptococcus pyogenesStreptococcus agalactiaeStreptococcus viridans groupStreptococcus pneumoniae | |
| Test Methodology | Automated quantitative antimicrobialsusceptibility test for use with theVITEK® 2 and VITEK® 2 CompactSystems to determine the in vitrosusceptibility of microorganisms | |
| Same | ||
| Antimicrobial Agent | Penicillin | |
| Same | ||
| Inoculum | Saline suspension of organism | |
| Same | ||
| Test Card | Streptococcus (AST-ST) SusceptibilityCard | |
| Same | ||
| Analysis Algorithms | Discriminant Analysis | |
| Same | ||
| Instrument | VITEK® 2 and VITEK® 2 CompactSystems | |
| 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
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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
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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
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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
| Antimicrobial | AntimicrobialCode | AntibioticVersion | 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 (meningitis). | (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 Streptococcus Viridans group (exceptStreptococcus pneumoniae). | (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.
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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.
§ 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.”