VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin

K232201 · bioMerieux, Inc. · LON · Oct 23, 2023 · Microbiology

Device Facts

• Record ID: K232201
• Device Name: VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Oct 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

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.

Device Story

VITEK 2 AST-Streptococcus Penicillin is an in vitro diagnostic test for determining antimicrobial susceptibility of Streptococcus species. The device uses 64-well cards containing premeasured penicillin and culture media. Clinical laboratory technicians prepare a saline suspension of the bacterial isolate, which is used to rehydrate the card. The VITEK 2 system automatically fills, seals, and incubates the card; the VITEK 2 Compact system requires manual filling/sealing. The system monitors well growth over time. Output includes MIC values and interpretive category results. Results assist clinicians in selecting appropriate antibiotic therapy for patients with streptococcal infections.

Clinical Evidence

Performance evaluated via external study comparing VITEK 2 Streptococcus Penicillin to CLSI broth microdilution reference method. Testing included fresh clinical isolates, stock isolates, and challenge strains. Results showed high Essential Agreement (97.7%–100%) and Category Agreement (89.7%–100%) across tested Streptococcus species. Reproducibility and quality control were acceptable.

Technological Characteristics

Microdilution MIC technique; 64-well plastic test cards containing premeasured antibiotic and culture media; automated incubation and optical growth monitoring; compatible with VITEK 2 and VITEK 2 Compact systems; uses discriminant analysis algorithms.

Indications for Use

Indicated for antimicrobial susceptibility testing of Streptococcus species (S. pneumoniae, beta-hemolytic Streptococcus groups C and G, S. pyogenes, S. agalactiae, S. viridans group) in clinical laboratories. Quantitative test for penicillin susceptibility.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• VITEK® 2 Streptococcus Penicillin (K112000)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-----------------------------------------------------------------|----------------------------------------------------------------|
| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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### 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<br>Hazelwood, MO 63042 |
| Contact Person: | Jared Bronson<br>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<br>Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility System<br>Product Code: LON, LTT, LTW |
| Common Name: | VITEK® 2 Streptococcus Penicillin |
| C. Predicate Device: | VITEK® 2 Streptococcus Penicillin (≤0.06 - ≥8 µg/mL)<br>(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 Predicate<br>Device(s): | Device: | Predicate Device: K112000 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | VITEK® 2 Streptococcus Penicillin | VITEK® 2 Streptococcus Penicillin |
| General Device Characteristic Similarities | | |
| Intended Use/Indications<br>for Use | VITEK® 2 Streptococcus Penicillin<br>is designed for antimicrobial<br>susceptibility testing of Gram-<br>positive microorganisms and is<br>intended for use with the VITEK® 2<br>and VITEK® 2 Compact Systems as<br>a laboratory aid in the determination<br>of in vitro susceptibility to<br>antimicrobial agents. VITEK® 2<br>Streptococcus Penicillin is a<br>quantitative test.<br><br>The VITEK® 2 Streptococcus<br>Susceptibility Card is intended for<br>use with the VITEK® 2 Systems in<br>clinical laboratories as an in vitro test<br>to determine the susceptibility of<br>Streptococcus pneumoniae, beta-<br>hemolytic Streptococcus, and | VITEK® 2 Streptococcus Penicillin is<br>designed for antimicrobial<br>susceptibility testing of Gram-positive<br>microorganisms and is intended for<br>use with the VITEK® 2 and VITEK®<br>2 Compact Systems as a laboratory aid<br>in the determination of in vitro<br>susceptibility to antimicrobial agents.<br>VITEK 2 Gram Positive Penicillin is a<br>quantitative test.<br><br>The VITEK® 2 Streptococcus<br>Susceptibility Card is intended for use<br>with the VITEK® 2 Systems in<br>clinical laboratories as an in vitro test<br>to determine the susceptibility of<br>Streptococcus pneumoniae, beta-<br>hemolytic Streptococcus, and Viridans<br>Streptococcus to antimicrobial agents |
| | | |
| Viridans <i>Streptococcus</i> to<br>antimicrobial agents when used as<br>instructed. | when used as instructed. | |
| Penicillin has been shown to be<br>active against most strains of the<br>microorganisms listed below,<br>according to the FDA label for this<br>antimicrobial. | Penicillin has an antimicrobial activity<br>against the microorganisms listed<br>below, according to the FDA label for<br>this antimicrobial. | |
| Active both in vitro and in clinical<br>infections:<br>Beta hemolytic <i>Streptococci</i> groups<br>C and G<br><i>Streptococcus pyogenes</i><br><i>Streptococcus agalactiae</i><br><i>Streptococcus viridans</i> group<br><i>Streptococcus pneumoniae</i> | Active in vitro and in clinical<br>infections:<br>Beta hemolytic <i>Streptococci</i> groups C<br>and G<br><i>Streptococcus pyogenes</i><br><i>Streptococcus agalactiae</i><br><i>Streptococcus viridans</i> group<br><i>Streptococcus pneumoniae</i> | |
| Test Methodology | Automated quantitative antimicrobial<br>susceptibility test for use with the<br>VITEK® 2 and VITEK® 2 Compact<br>Systems to determine the <i>in vitro</i><br>susceptibility of microorganisms | |
| | Same | |
| Antimicrobial Agent | Penicillin | |
| | Same | |
| Inoculum | Saline suspension of organism | |
| | Same | |
| Test Card | <i>Streptococcus</i> (AST-ST) Susceptibility<br>Card | |
| | Same | |
| Analysis Algorithms | Discriminant Analysis | |
| | Same | |
| Instrument | VITEK® 2 and VITEK® 2 Compact<br>Systems | |
| | Same | |
| Concentrations | 0.06, 0.12, 0.5, 2 | |
| | Same | |
| General Device Characteristic Differences | | |
| Breakpoints | <i>S. pneumoniae</i> (non-meningitis) [≤2 / 4 / ≥8] <i>S. pneumoniae</i> (meningitis) [≤0.06/ - /≥0.12] <i>Viridans Streptococci</i> [≤0.12/0.25-2/≥4] Beta-hemolytic <i>Streptococcus</i> [≤0.12/-/-] <i>S. pneumoniae</i> (oral/non-meningitis) [≤0.06/0.12-1/≥2] | |
| | <i>S. pneumoniae</i> (non-meningitis) [≤2 / 4 / ≥8] <i>S. pneumoniae</i> (meningitis) [≤0.06/ - /≥0.12] <i>Viridans Streptococci</i> [≤0.12/0.25-2/≥4] Beta-hemolytic <i>Streptococcus</i> [≤0.12/-/-] <i>S. pneumoniae</i> (oral) [none] | |

#### Table 1: Substantial Equivalence

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# 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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# VITEK® 2 Streptococcus Penicillin

| Antimicrobi<br>al | Antimic<br>robial<br>Code | Antibio<br>tic<br>Version | Bp1 | Comment | Essential Agreement Category | | | | Category Agreement | | | |
|-------------------|---------------------------|---------------------------|---------------|-----------------------------------------------------------------------------------------|------------------------------|-----|-----|-----|--------------------|-----------------|-----------------|-------------------|
| | | | | | %EA | VME | ME | mE | %CA | VME | ME | mE |
| Penicillin | P | (p01n) | CLSI<br>(FDA) | #, E Strepto-<br>coccus pneu-<br>moniae (non-<br>meningitis). | (342/350)<br>97.7 | N/A | N/A | N/A | (323/350)<br>92.3 | (0/0)<br>0.0 | (0/304)<br>0.0 | (27/350)<br>7.7 |
| | | | | #, E Strepto-<br>coccus pneu-<br>moniae (oral). | (342/350)<br>97.7% | N/A | N/A | N/A | (314/350)<br>89.7% | (0/94)<br>0.0% | (0/189)<br>0.0% | (36/350)<br>10.3% |
| | | | | #, E Strepto-<br>coccus pneu-<br>moniae (menin<br>gitis). | (342/350)<br>97.7% | N/A | N/A | N/A | (342/350)<br>97.7% | (2/161)<br>1.2% | (6/189)<br>3.2% | N/A |
| | | | | #, E Strepto<br>coccus Viridan<br>s group (except<br>Strepto<br>coccus pneum<br>oniae). | (385/391)<br>98.5% | N/A | N/A | N/A | (368/391)<br>94.1% | (0/15)<br>0.0% | (0/268)<br>0.0% | (23/391)<br>5.9% |
| | | | | #, E Beta-<br>hemoly-<br>tic Strepto-<br>coccus | (833/833)<br>100% | N/A | N/A | N/A | (833/833)<br>100% | (0/0)<br>0.0% | (0/833)<br>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:

- 1. 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.
- 2. 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.