(77 days)
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No
The description focuses on the microdilution technique and automated monitoring of growth, with no mention of AI or ML algorithms for interpretation or analysis.
No.
This device is an in vitro diagnostic (IVD) device used for antimicrobial susceptibility testing, which aids in determining the effectiveness of antibiotics against specific microorganisms. It does not directly treat or diagnose a disease in a patient.
Yes
Explanation: The device is designed for "antimicrobial susceptibility testing of Streptococcus species" and is a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," which directly assists in diagnosing and guiding treatment for bacterial infections.
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 processed by the VITEK® 2 Systems (hardware). This is not a software-only device.
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 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 test performed on a sample (bacterial or yeast isolate) outside of the body, using a specific card with premeasured reagents. This is characteristic of an in vitro test.
- Clinical Laboratories: The "Intended User / Care Setting" is listed as "clinical laboratories," which are the typical settings for performing IVD tests.
- Performance Studies: The performance studies compare the device's results to a "CLSI broth microdilution reference method," which is a standard method for in vitro susceptibility testing.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K111893) indicates that this device is being compared to a previously cleared medical device, which is a process for IVDs.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
VITEK® 2 Streptococcus Tetracycline 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 Tetracycline is a quantitative test. Tetracycline has been shown to be active against the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections: Streptococcus pneumoniae Streptococcus pyogenes*
*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. 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 Streptococcus pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.
Product codes
LON
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 and Gerlach. The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique.
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 Tetracycline has the following concentrations in the card: 0.125, 0.5, 1, and 4 ug/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 Tetracycline by comparing its performance with the CLSI broth microdilution reference method incubated at 16-24 hrs. 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)
VITEK® 2 Streptococcus Tetracycline 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).
VITEK® 2 Streptococcus Tetracycline (≤0.25 - ≥16 µg/mL) demonstrated acceptable performance of 98.3% overall Essential Agreement and 97.9% overall Category Agreement with the reference method as presented in Table 2 below:
Tetracycline (Streptococcus pneumoniae): Essential Agreement (284/289) 98.3%, Category Agreement (288/289) 99.7%. VME 0.0% (0/83), ME 0.0% (0/206), mE 0.3% (1/289).
Tetracycline (Streptococcus pyogenes): Essential Agreement (307/308) 99.7%, Category Agreement (308/308) 100.0%. VME 0.0% (0/28), ME 0.0% (0/280), mE 0.0% (0/308).
Tetracycline (Beta-hemolytic Streptococcus (Other than Streptococcus pyogenes)): Essential Agreement (518/530) 97.7%, Category Agreement (509/530) 96.0%. VME 0.6% (2/348), ME 0.6% (1/166), mE 3.4% (18/530).
Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement, Category Agreement, VME (Very Major Error), ME (Major Error), mE (Minor Error).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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February 3, 2023
bioMérieux, Inc Jared Bronson Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042
Re: K223481
Trade/Device Name: VITEK 2 Streptococcus Tetracycline (16 ug/mL)
Indications for Use (Describe)
VITEK® 2 Streptococcus Tetracycline 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 Tetracycline is a quantitative test. Tetracycline has been shown to be active against the microorganisms listed below, according to the FDA label for this antimicrobial.
Active in vitro and in clinical infections: Streptococcus pneumoniae Streptococcus pyogenes*
*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. 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 Streptococcus 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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510(k) SUMMARY
VITEK® 2 Streptococcus Tetracycline (≤ 0.25 -> 16 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: | 314-731-8799 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | February 02, 2023 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Streptococcus Tetracycline (≤ 0.25 - ≥ 16 |
| µg/mL) | |
| Classification Name: | 21 CFR 866.1645 |
| Fully Automated Short-Term Incubation Cycle | |
| Antimicrobial Susceptibility System | |
| Product Code: LON | |
| Common Name: | VITEK® 2 Streptococcus Tetracycline |
| C. Predicate Device: | VITEK® 2 Streptococcus Tetracycline (≤ 0.25 - ≥ 16 |
| µg/mL) (K111893) |
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).
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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 Tetracycline has the following concentrations in the card: 0.125, 0.5, 1, and 4 ug/mL (equivalent standard method concentration by efficacy in ug/mL).
E. Substantial Equivalence Information:
The similarities and differences of the VITEK® 2 Streptococcus Tetracycline when compared to the predicate device, VITEK® 2 Streptococcus Tetracycline (K111893), are described in the following table. The differences between both devices include the addition of Streptococcus pneumoniae and Beta hemolytic streptococcus spp. breakpoints and removal of Streptococcus spp. breakpoint, as well as narrowing the indications for use to Streptococcus pneumoniae and Streptococcus pyogenes.
| Device and Predicate
| Device(s): | Device: | Predicate Device: K111893 |
|---|---|---|
| Device Trade Name | VITEK® 2 Streptococcus Tetracycline | |
| (≤ 0.25 – ≥ 16 µg/mL) | VITEK® 2 Streptococcus Tetracycline | |
| Intended Use | VITEK® 2 Streptococcus Tetracycline 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 Tetracycline is a | ||
| quantitative test. Tetracycline has been | ||
| shown to be active against most strains | ||
| of the microorganisms listed below, | ||
| according to the FDA label for this | ||
| antimicrobial. | VITEK® 2 Streptococcus Tetracycline is | |
| designed for antimicrobial susceptibility | ||
| testing of Streptococcus species. | ||
| VITEK® 2 Streptococcus Tetracycline is | ||
| a quantitative test intended for use with | ||
| the VITEK® 2 and the VITEK® 2 | ||
| Compact Systems as a laboratory aid in | ||
| the determination of in vitro | ||
| susceptibility to antimicrobial agents. | ||
| Tetracycline has an antimicrobial activity | ||
| against the microorganisms listed below, | ||
| according to the FDA label for this | ||
| antimicrobial. | ||
| 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 | ||
| Streptococcus pneumoniae , beta- | ||
| hemolytic Streptococcus , and | ||
| Viridans Streptococcus to | ||
| antimicrobial agents when used as | ||
| instructed. | The VITEK® 2 Antimicrobial | |
| Susceptibility Test (AST) is intended to | ||
| be used with the VITEK® 2 System 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 clinically significant yeast. | ||
| 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 | Tetracycline | 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 | 0.125, 0.5, 1, 4 | Same |
| General Device Characteristic Differences | ||
| Breakpoints | Streptococcus pneumoniae | |
| $S ≤ 1$ , I 2, $R ≥ 4$ |
Beta hemolytic Streptococcus species
(including S. pyogenes )
$S ≤ 2$ , I 4, $R ≥ 8$ | Streptococcus spp.
$S ≤ 4$ , I 8, $R ≥ 16$ |
| Indications for Use | Active in vitro and in clinical
infections :
Streptococcus pneumoniae
Streptococcus pyogenes *
*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 | Active in vitro and in clinical infections :
Streptococcus pneumoniae
Streptococcus pyogenes
Viridans group streptococci |
Table 1: Substantial Equivalence
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VITEK® 2 Streptococcus Tetracycline
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| (STIC): Streptococcus spp. ß- | |
|---|---|
| Hemolytic Group (other than S. | |
| pyogenes). |
F. Intended Use:
VITEK® 2 Streptococcus Tetracycline 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 Tetracycline is a quantitative test. Tetracycline 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*
*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. 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 Streptococcus pneumoniae, beta-hemolytic Streptococcus, and Viridans Streptococcus to antimicrobial agents when used as instructed.
G. Performance Overview and Conclusion:
VITEK® 2 Streptococcus Tetracycline 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 (510[k]) presents data in support of VITEK® 2 Streptococcus Tetracycline. 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 Tetracycline by comparing its performance with the CLSI broth
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microdilution reference method incubated at 16-24 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.
VITEK® 2 Streptococcus Tetracycline (≤0.25 - ≥16 µg/mL) demonstrated acceptable performance of 98.3% overall Essential Agreement and 97.9% overall Category Agreement with the reference method as presented in Table 2 below:
| Antimi-
| crobial | Comment | Essential Agreement Category | Category Agreement | ||||||
|---|---|---|---|---|---|---|---|---|---|
| % Error | % Error | ||||||||
| %EA | VME | ME | mE | %CA | VME | ME | mE | ||
| Tetracycline | Streptococcus pneumoniae. | (284/289) | |||||||
| 98.3% | N/A | N/A | N/A | (288/289) | |||||
| 99.7% | (0/83) | ||||||||
| 0.0% | (0/206) | ||||||||
| 0.0% | (1/289) | ||||||||
| 0.3% | |||||||||
| Streptococcus pyogenes. | (307/308) | ||||||||
| 99.7% | N/A | N/A | N/A | (308/308) | |||||
| 100.0% | (0/28) | ||||||||
| 0.0% | (0/280) | ||||||||
| 0.0% | (0/308) | ||||||||
| 0.0% | |||||||||
| Beta-hemolytic Streptococcus (Other than Streptococcus pyogenes). | (518/530) | ||||||||
| 97.7% | N/A | N/A | N/A | (509/530) | |||||
| 96.0% | (2/348) | ||||||||
| 0.6% | (1/166) | ||||||||
| 0.6% | (18/530) | ||||||||
| 3.4% |
Table 2: VITEK® 2 Streptococcus Tetracycline Performance
Reproducibility and Quality Control demonstrated acceptable results.
H. The performance data presented in the submission support a substantial equivalence decision. VITEK® 2 AST-Streptococcus Tetracycline (≤0.25 ->16 µg/mL) is substantially equivalent to VITEK® 2 AST Streptococcus Tetracycline (K111893).
G. 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.
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- 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.