(93 days)
No
The description focuses on automated quantitative/qualitative susceptibility testing using a miniaturized doubling dilution technique and monitoring growth over time. There is no mention of AI or ML algorithms being used for interpretation or analysis.
No.
Explanation: The device is a diagnostic tool used to determine the susceptibility of bacteria to antimicrobial agents, aiding in treatment decisions but not directly providing therapy.
Yes
Explanation: The device is used for automated quantitative or qualitative susceptibility testing of isolated colonies to antimicrobial agents, which aids in determining the appropriate treatment for infections. This directly contributes to diagnosing the susceptibility of bacteria to drugs, which falls under the definition of a diagnostic device.
No
The device description clearly outlines physical components like "VITEK 2 AST Cards" containing antimicrobial medium and mentions the "VITEK 2 System" and "VITEK 2 Compact" instruments which are hardware. The submission is for an addition of interpretive criteria, which is software-related, but the core device involves hardware for testing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is for "in vitro susceptibility testing of isolated colonies" and acts as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description details how the device tests bacterial isolates in a laboratory setting by rehydrating antimicrobial medium within a card and monitoring growth. This process is performed in vitro (outside the body).
- Performance Studies: The performance studies compare the device's performance to a "CLSI broth microdilution reference method," which is a standard laboratory technique for in vitro susceptibility testing.
All these points confirm that the VITEK® 2 Gram Positive Erythromycin for Streptococcus pneumoniae is designed and used for testing biological samples in vitro to aid in clinical decision-making, making it an IVD.
N/A
Intended Use / Indications for Use
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae:
VITEK® 2 Gram Positive Erythromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Gram positive Streptococcus pneumoniae 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 Erythromycin for Streptococcus pneumoniae is a qualitative test.
This submission is for the addition of an intermediate interpretive criteria.
Erythromycin has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.
Active in vitro and in clinical infections: Streptococcus pneumoniae
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
VITEK® 2 Gram Positive Erythromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococus pneumoniae. It is intended for use with the VITEK 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mog/ml. The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% 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 and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Erythromycin for Streptococcus pneumoniae by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK 2 Gram Positive Erythromycin for Streptococcus pneumoniae demonstrated acceptable performance of 98.4% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
98.4% overall Category Agreement
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.
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
1083383
BIOMÉRIEUX
FEB 1 8 2009
510(k) SUMMARY
VITEK® 2 Gram Positive Erythromycin for Streptococcus pneumoniae
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenllado |
| Associate Staff Regulatory Affairs Specialist | |
| Phone Number: | 314 -731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | November 14, 2008 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Erythromycin for Streptococcus |
| pneumoniae | |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GP Erythromycin for Streptococcus |
| pneumoniae | |
| Predicate Device: | VITEK 2 Gram Positive Telithromycin for Streptococcus |
D, 510(k) Summary:
в.
C.
. A 510(k) for VITEK 2 Gram Positive Erythromycin for Streptococcus pneumoniae (K063492) was cleared by FDA on 21Dec2006. This premarket notification is for the same AST with the only modification being a software algorithm change to utilize the existing FDA intermediate breakpoint for Erythromycin and S. pneumoniae, and thereby lift the VITEK 2 Systems limitation regarding the inability of the Systems to report intermediate results for Erythromycin and S. pneumoniae strains. There has been no change to the VITEK 2 AST-GP Erythromcyin for S. pneumoniae formulation since K063492 was cleared. The analysis was modified to conform to standard practice of reporting results for all available FDA breakpoints for an antibiotic/organism combination. The clinical trial data submitted as part of K063492 was re-analyzed using the modified algorithm analysis. There was no new clinical data gathered for this 510(k) notification. The modified algorithm for this AST will be included in a future software release (VITEK 2 Systems software version PC 4.01).
pneumoniae (K053186).
VITEK® 2 Gram Positive Erythromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Streptococus pneumoniae. It is intended for use with the VITEK 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK 2 AST Cards is in concentrations equivalent by efficacy to standard method concentrations in mog/ml. The VITEK 2 AST Cards are
bioMérieux, Inc.
Fax: 314/731-800/638-4835 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 8700
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essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% 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 and sealing operation. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). 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 Gram Positive Erythromycin for Streptococcus pneumoniae demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA, Issued Feb. 5, 2003.
The Premarket Notification (510[k]) presents data in support of VITEK 2 Gram Positive Erythromycin for Streptococcus pneumoniae. An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains. The external evaluations were designed to confirm the acceptability of VITEK 2 Gram Positive Erythromycin for Streptococcus pneumoniae by comparing its performance with the CLSI broth microdilution reference method. The data is representative of performance on both the VITEK 2 and VITEK 2 Compact instrument platforms, as evidenced in the AST equivalency study presented in the VITEK 2 Compact 510(k), K050002. VITEK 2 Gram Positive Erythromycin for Streptococcus pneumoniae demonstrated acceptable performance of 98.4% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FFB 1 8 2009
Ms. Jolyn Tenllado Associate Staff Regulatory Affairs Specialist bioMérieux 595 Anglum Road Hazelwood. MO 63042
Re: K083383
Trade/Device Name: VITEK® 2 Gram Positive Erythromycin (≤ 0.25 .- ≥ 1. jig/til) Regulation Number: 21 CFR § 866.1645 Regulation Name: Antimicrobial Susceptibility Test System - Short Incubation Regulatory Class: II Product Code: LON Dated: November 14, 2008 Received: November 17, 2008
Dear Ms. Tenllado:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041, or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attaymto
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Fealth
Enclosure
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Indications for Use
510(k) Number (if known): K083383
Device Name: VITEK® 2 Gram Positive Erythromycin ( 1 ug/ml)
Indications For Use:
:
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gramnegative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae:
VITEK® 2 Gram Positive Erythromycin for Streptococcus pneumoniae is designed for antimicrobial susceptibility testing of Gram positive Streptococcus pneumoniae 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 Erythromycin for Streptococcus pneumoniae is a qualitative test.
This submission is for the addition of an intermediate interpretive criteria.
Ervthromcvin has been shown to be active against the microorganisms listed below according to the FDA label for the antimicrobial.
Active in vitro and in clinical infections: Streptococcus pneumoniae
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart.C)
(PEEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Freddie In Cooke
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K08 3383
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