(42 days)
N50510/S143
Not Found
No
The description focuses on optical monitoring and automated calculation based on a predetermined growth threshold, not AI/ML algorithms. There is no mention of AI, ML, or related terms.
No
The device is a laboratory aid for determining in vitro antimicrobial susceptibility, not a device used to treat patients or alleviate a medical condition.
Yes
The device is intended for susceptibility testing to determine the in vitro susceptibility of microorganisms to antimicrobial agents, which is a key component of diagnosing and guiding treatment for infections. It's explicitly described as a "laboratory aid in the determination of in vitro susceptibility to antimicrobial agents," implying its role in the diagnostic process.
No
The device description explicitly mentions "VITEK GPS Cards" which are physical components containing antimicrobial agents and are inoculated with organism suspensions. The system also includes a "Reader/Incubator" which is hardware. Therefore, the device is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "in vitro susceptibility testing of isolated colonies" and "as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents." This clearly indicates testing is performed outside of the body on biological samples (isolated colonies of bacteria).
- Device Description: The description details how the device works by "optically monitored throughout the 6-15 hour incubation cycle" after being "inoculated with a standardized organism suspension." This process of testing a biological sample in a laboratory setting is characteristic of an IVD.
- Performance Studies: The performance studies compare the device's performance to a "reference method" for susceptibility testing, further confirming its role in laboratory diagnostics.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device fits that description by testing bacterial isolates to determine their susceptibility to antibiotics.
N/A
Intended Use / Indications for Use
The VITEK® Gram Positive Susceptibility Test is intended to be used with the VITEK® System for automated quantitative or qualitative susceptibility testing of isolated clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. VITEK® Gram Positive Rifampin is designed for antimicrobial susceptibility testing of Staphylococcus aureus and Staphylococcus epidermidis. VITEK Gram Positive Rifampin is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
Product codes
LON
Device Description
VITEK® Gram Positive Rifampin is designed for antimicrobial susceptibility testing of Staphyloccocus aureus and Staphylococcus epidermidis. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK GPS Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GPS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
After the card is inoculated with a standardized organism suspension, it is placed in the Reader/Incubator of the VITEK System. Organism growth inside the card is optically monitored throughout the 6-15 hour incubation cycle. MIC results are automatically calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.
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
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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 r nice challenge strains. The external evaluations were designed to confirm the acceptability of VITEK Gram Positive Rifampin by comparing its performance with the NCCLS agar dillution reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
VITEK Gram Positive Rifampin demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the FDA Class U Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued Feb. 5, 2003.
VITEK Gram Positive Rifampin demonstrated acceptable performance of 98.9% overall Category Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
98.9% overall Category Agreement
Predicate Device(s)
N50510/S143
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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DFC - 7 2004
Image /page/0/Picture/2 description: The image shows the logo for bioMérieux. The logo consists of the company name in block letters, with a stylized black circle above it. A thin, curved line extends from the top and bottom of the circle, bisecting the logo vertically.
510(k) SUMMARY
VITEK® Gram Positive Rifampin
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: | October 22, 2004 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® Gram Positive Rifampin (0.25 - 1.5 µg/ml) |
| Classification Name: | Fully Automated Short-Term Incubation Cycle |
| Antimicrobial Susceptibility Device. | |
| 21 CFR 866.1645 | |
| Common Name: | VITEK GPS Rifampin (Rifampin 2003, RA 2003) |
| C. Predicate Device: | VITEK Gram Positive Susceptibility (GPS) Card for |
| Gatifloxacin (N50510/S143) |
D. 510(k) Summary:
VITEK® Gram Positive Rifampin is designed for antimicrobial susceptibility testing of Staphyloccocus aureus and Staphylococcus epidermidis. It is intended for use with the VITEK® System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. The antimicrobial presented in VITEK GPS Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK GPS Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.
After the card is inoculated with a standardized organism suspension, it is placed in the Reader/Incubator of the VITEK System. Organism growth inside the card is optically monitored throughout the 6-15 hour incubation cycle. MIC results are automatically calculated once a predetermined growth threshold is reached, and a report is generated that contains the MIC result and the interpretive category result.
1
VITEK Gram Positive Rifampin demonstrated substantially equivalent performance when compared with the NCCLS reference agar dilution method, as defined in the FDA Class U 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 Gram Positive Rifamin. An external evaluation was conducted with fresh and stock clinical isolates r nice challenge strains. The external evaluations were designed to confirm the acceptability of VITEK Gram Positive Rifampin by comparing its performance with the NCCLS agar dillution reference method. VITEK Gram Positive Rifampin demonstrated acceptable performance of 98.9% overall Category Agreement when compared to the agar dilution reference method. Reproducibility and Quality Control demonstrated acceptable results.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping, curved lines representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC - 7 2004
Ms. Jolyn Tenllado Regulatory Affairs Specialist BioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042-2320
K042946 Re:
Ro+2940
Trade/Device Name: VITEK® Gram Positive Rifampin (≤0.25 - ≥4 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: October 22, 2004 Received: October 26, 2004
Dear Ms. Tenllado:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave rowled 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 for use bared in the enactment date of the enactment date of the Medical Device Amendments, or to conimered provise 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). and Cosmetic rear (110.) that the device, subject to the general controls provisions of the Act. The r ou may, diererere, mains 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 it indy of bacies of Saccord 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 i lease of actived and i termination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I edolar statutes and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice erequirements 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) I his lower with and my your e FDA finding of substantial equivalence of your device to a legally promatics notification " results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or you dents on the promotion and advertising of your device, please contact the Office of or questions on atte promise Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Saqartys
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): ___K042946
Device Name: VITEK® Gram Positive Rifampin (4 µg/ml)
Indications For Use:
The VITEK® Gram Positive Susceptibility Test is intended to be used with the VITEK® The VI LA *G antomated quantitative or qualitative susceptibility testing of isolated oystem for the most clinically significant aerobic gram-negative bacilli, Staphylooocus sport Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae. VITEK® Gram Spp., Enterooooooo opp., On antimicrobial susceptibility testing of Staphylococcus r ositive Filiampir. Is doogra epidermidis. VITEK Gram Positive Rifampin is for aurous und elaphyrooooooooo opensied for use with the VITEK System as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.
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)
Freddi H. Poole
ision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
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