(47 days)
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No
The description focuses on automated quantitative/qualitative susceptibility testing using a miniaturized doubling dilution technique and monitoring bacterial growth. There is no mention of AI or ML in the intended use, device description, or the sections specifically checked for AI/ML terms. The performance studies compare the device to a reference method, not an AI/ML model.
No
The device is described as an "Antimicrobial Susceptibility Test" used to determine in vitro susceptibility to antimicrobial agents, which is a diagnostic function, not a therapeutic one. It provides information to aid in the determination of treatment, but does not itself treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section states that the VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended for "automated quantitative or qualitative susceptibility testing" and "is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This indicates its role in determining the susceptibility of bacteria to antibiotics, which directly aids in diagnosing and guiding treatment for infections.
No
The device description explicitly mentions "VITEK 2 AST Cards" and the "VITEK 2 System," which are physical components used in the testing process. The description details the physical handling of the cards and the automated filling, sealing, and incubation by the VITEK 2 System. This indicates the device is a system involving both hardware and software, not software-only.
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 VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended for the "automated quantitative or qualitative susceptibility testing of isolated colonies." This involves testing biological samples (bacterial isolates) in vitro (outside of the body) to provide information about a patient's potential response to antimicrobial agents.
- Device Description: The description details how the device works by testing bacterial isolates in a miniaturized microdilution format. This is a classic in vitro diagnostic method.
- Intended User / Care Setting: It is described as a "laboratory aid," which is a typical setting for IVD devices.
- Performance Studies: The performance studies compare the device's results to a "reference method," which is standard practice for validating IVD devices.
The core function of the device is to analyze a biological sample (bacterial isolate) in vitro to provide information relevant to patient care (antimicrobial susceptibility). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK 2 System for the automated qualitative or qualitative susceptibility testing of Enterobacteriaceae, Pseudomonas aeruginosa, other non-enteric Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and Streptococcus pneumoniae. VITEK 2 Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Enterococcus faecium, Staphylococcus epidermidis and Staphylococcus haemolyticus. It is intended for use with the VITEK 2 System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
Product codes
LON
Device Description
VITEK® 2 Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Enterococcus faecium, Staphylococcus epidermidis and Staphylococcus haemolyticus. It is intended for use with the VITEK 2 System 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 mcg/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 automatically fills, seals and places the card into the incubator/reader. 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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 Daptomycin by comparing its performance with the NCCLS broth microdilution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 Gram Positive Daptomycin demonstrated substantially equivalent performance when compared with the NCCLS reference broth microdilution 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.
VITEK 2 Gram Positive Daptomcyin demonstrated acceptable performance of 98.2% overall Essential Agreement and 100% overall Category Agreement when compared to the broth microdilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: 98.2%
Category Agreement: 100%
Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for BioMerieux. The logo consists of the word "BIOMERIEUX" in a stylized font. Above the text is a black circle with a design that resembles a tree or plant.
FEB 2 8 2005
510(k) SUMMARY
VITEK® 2 Gram Positive Daptomycin
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenllado |
| Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | January 10, 2005 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Daptomycin |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, | |
| 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GP Daptomycin |
| C. Predicate Device: | VITEK 2 Gram Positive Susceptibility Test for |
| Linezolid (K032766) |
D. 510(k) Summary:
VITEK® 2 Gram Positive Daptomycin is designed for antimicrobial susceptibility testing of Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Enterococcus faecium, Staphylococcus epidermidis and Staphylococcus haemolyticus. It is intended for use with the VITEK 2 System 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 mcg/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 automatically fills, seals and places the card into the incubator/reader. The VITEK 2 monitors the growth of each well in the card over a defined period of time (up
1
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 Daptomycin demonstrated substantially equivalent performance when compared with the NCCLS reference broth microdilution 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 Daptomycin. 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 Daptomycin by comparing its performance with the NCCLS broth microdilution reference method. VITEK 2 Gram Positive Daptomcyin demonstrated acceptable performance of 98.2% overall Essential Agreement and 100% overall Category Agreement when compared to the broth microdilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
FEB 2 8 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Jolyn Tenllado Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
K050075 Rc:
KU50073
Trade/Device Name: VITEK® 2 Gram Positive Daptomycin (≤0.5 - ≥16 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: January 10, 2005 Received: January 12, 2005
Dear Ms. Tenllado:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 310(x) premium is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosals) to regists and ment date of the Medical Device American processes of commerce print to May 20, 1770, in the provisions of the Federal Food, Drug, uevices mat have been resulted mequire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not requent of the general controls provisions of the Act. The 1 ou may, ulciclere, market the act include requirements for annual registration, listing of general controls provisions and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classified (doo as controls. Existing major regulations affecting your device it may be subject to submadations (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 can be found in Title Brouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that I Drivedants of rour device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of ally if ederal statutes and regulations ancluding, but not limited to: registration and listing (21 confity with an the Ace 31equirements, on and 809); and good manufacturing practice to CI K Fart 807), labeling (21 Se 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) This letter will allow you to begin marketing your article of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The FDA miding of bassance of the super and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, of In if you desire specific information avour trising of your device, please contact the Office of In
or questions on the promotion and advertising of your a season of the or questions on the promotion and ad rerrisonig or your and Safety at (2016) 276-0484. Also, please note the CCCD Parl Vitro Diagnostic Device Evaluation and Bareer at (210). And Sun Sun Since in Sun. Act from the regulation entitled, "Misolanding by reisenes we responsibilities under the Act from the You may obtain other general information on your copyour Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address (000) 050 = fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Sales, a. Forg
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 Health
Enclosure
4
Indications for Use
510(k) Number (if known):____K050075
Device Name: VITEK® 2 Gram Positive Daptomycin (