(93 days)
No
The description focuses on a traditional automated susceptibility testing method based on monitoring bacterial growth in the presence of antimicrobials, not AI/ML algorithms. There are no mentions of AI, ML, or related concepts.
No.
This device is described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents" and is used for "antimicrobial susceptibility testing," indicating it is an in vitro diagnostic (IVD) device, not a therapeutic device.
Yes
This device is designed for antimicrobial susceptibility testing of Staphylococcus species, which is a key step in diagnosing and guiding treatment for bacterial infections. It serves as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," directly contributing to diagnostic decision-making.
No
The device description explicitly mentions "VITEK 2 AST Cards" which are physical components containing antimicrobial medium, and the system involves filling, sealing, and incubating these cards. This indicates the device includes hardware components beyond just software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states the device is "designed for antimicrobial susceptibility testing of Staphylococcus species" and is intended for use "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates the device is used to test samples in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details how the device works by testing bacterial isolates diluted in saline and monitoring their growth in the presence of antimicrobial agents. This process is characteristic of in vitro diagnostic testing.
- Performance Studies: The performance studies compare the device's performance to a "CLSI Disk Approximation Test reference method," which is a standard in vitro diagnostic method for susceptibility testing.
- Intended User: The intended user is a "laboratory aid," further supporting its use in a clinical laboratory setting for diagnostic purposes.
Therefore, all the key elements point to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
VITEK® 2 Gram Positive Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus species. VITEK 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test. 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
VITEK® 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test designed for antimicrobial susceptibility testing of Staphylococcus species. A positive ICR test is indicative of inducible MLS, resistance, which confers resistance to macrolides, lincosamides, and type B
inducible MLS, resistance, which confers resistance to macrolides, and VITEK® 2 Co 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% - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System belomatically 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 over a delined pend of the (up to To Tronice). It 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
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 Inducible Clindamycin Resistance by comparing its performance with the CLSI Disk Approximation Test 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK 2 Gram Positive Inducible Clindamycin Resistance demonstrated substantially equivalent performance when compared with the CLSI Disk Approximation Test 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.
VITEK 2 Gram Positive Inducible Clindamycin Resistance demonstrated acceptable performance of 99.3% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
99.3% 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.
VITEK 2 Gram Positive Cefoxitin Screen (K053097)
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
Image /page/0/Picture/1 description: The image shows the logo for BIOMÉRIEUX. The logo consists of the company name in block letters, with a stylized graphic above it. The graphic features a black circle with lines emanating from it, bisected by a curved line.
APR 3 0 2008
510(k) SUMMARY
VITEK® 2 Gram Positive Inducible Clindamycin Resistance
510(k) Submission Information:
| Submitter's Name: | bioMérieux, Inc. |
|---|---|
| Address: | 595 Anglum Road |
| Hazelwood, MO 63042 | |
| Contact Person: | Jolyn Tenllado |
| Senior Regulatory Affairs Specialist | |
| Phone Number: | 314-731-8386 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | January 24, 2008 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 Gram Positive Inducible Clindamycin |
| Resistance | |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device, 21 CFR 866.1645 | |
| Common Name: | VITEK 2 AST-GP Inducible Clindamycin Resistance |
| C. Predicate Device: | VITEK 2 Gram Positive Cefoxitin Screen (K053097). |
D. 510(k) Summary:
в.
VITEK® 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test designed for antimicrobial susceptibility testing of Staphylococcus species. A positive ICR test is indicative of inducible MLS, resistance, which confers resistance to macrolides, lincosamides, and type B
inducible MLS, resistance, which confers resistance to macrolides, and VITEK® 2 Co 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% - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 System belomatically 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 over a delined pend of the (up to To Tronice). It the interpretive category result for each antibiotic contained on the card.
VITEK 2 Gram Positive Inducible Clindamycin Resistance demonstrated substantially equivalent performance when compared with the CLSI Disk Approximation Test reference method, as defined
bioMérieux, Inc.
Fax: 314/731-Phone: 314/731-8500 800/638-4835 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA 8700
1
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 Inducible Clindamycin Resistance. 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 Inducible Clindamycin Resistance by comparing its performance with the CLSI Disk Approximation Test 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 Inducible Clindamycin Resistance demonstrated acceptable performance of 99.3% overall Category Agreement. Reproducibility and Quality Control demonstrated acceptable results.
*Note: This device clinical trial was initiated prior to the March 5, 2007 issuance of the revised guidance, which is why the older guidance document is cited.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right and is composed of several curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 3 0 2008
Mr. John Tenllado Senior Regulatory Affairs Specialist bioMérieux 595 Anglum Road Hazelwood, MO 63042
Re: K080201
Trade/Device Name: VITEK® 2 Gram Positive Inducible Clindamycin Resistance Regulation Number: 21 CFR § 866.1645 Regulation Name: Antimicrobial Susceptibility Test System -- Short Incubation Regulatory Class: II Product Code: LON Dated: April 17th, 2008 Received: April 18th, 2008
Dear Mr. 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, isting 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 attaym
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):_k 080201
Device Name: VITEK® 2 Gram Positive Inducible Clindamycin Resistance
Indications For Use:
VITEK® 2 Gram Positive Inducible Clindamycin Resistance is designed for antimicrobial susceptibility testing of Staphylococcus species. VITEK 2 Gram Positive Inducible Clindamycin Resistance is a qualitative test. 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 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Freddie Poole
Page 1 of 1
Sion Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K08 0201