(25 days)
Not Found
No
The description focuses on traditional broth dilution methods and instrument-based reading of growth inhibition, with no mention of AI or ML technologies.
No.
The device is used to determine the susceptibility of bacteria to antimicrobial agents, which is a diagnostic function, not a therapeutic one.
Yes
The device is used to determine bacterial antimicrobial agent susceptibility, which involves identifying the effectiveness of antibiotics against specific bacteria. This information is crucial for diagnosing and guiding treatment decisions for infections, thus qualifying it as a diagnostic device.
No
The device description explicitly mentions a "MicroScan® WalkAway instrument" which is a piece of hardware used for incubation and reading of the panels. The submission is for the addition of instrument read capability, indicating reliance on this hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "determine bacterial antimicrobial agent susceptibility." This is a diagnostic test performed on a sample taken from a patient (in this case, bacterial colonies grown from a sample).
- Device Description: The device is a "miniaturization of the broth dilution susceptibility test," which is a standard laboratory method for determining how well bacteria are inhibited by different antibiotics. This process is performed in vitro (outside the body).
- Performance Studies: The performance studies compare the device's results to "Expected Results" and a "CLSI frozen Reference Panel," which are standard methods used in clinical laboratories for diagnostic testing.
- Predicate Device: The predicate device is also an "Antimicrobial Susceptibility Test (AST) System," which falls under the category of IVDs.
The device is used to analyze a biological sample (bacterial colonies) in vitro to provide information about a patient's condition (the susceptibility of the bacteria causing an infection to different antibiotics), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: To determine bacterial antimicrobial agent susceptibility
Indications for Use: The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
This particular submission is for the addition of instrument read capability of the antimicrobial Vancomycin, at concentrations of 0.06 to 8 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Vancomycin susceptibility testing in this panel are:
Streptococcus pneumoniae (including penicillin-resistant strains) Streptococcus pyogenes Streptococcus agalactiae the viridans group Streptococcus bovis
Product codes
LRG, LTT
Device Description
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/-1 °C in a non-CO2 incubator, and read according to the Package Insert.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.
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
The external evaluation was conducted with stock and CDC Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation. The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of 100% for Vancomycin instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Vancomcyin and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Vancomycin.
Key Metrics
Essential Agreement of 100%
Predicate Device(s)
MicroScan MICroSTREP plus® Panel (K020822)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
0
SEP - 1 2006
510(k) Summary Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | Shannon Popson, Regulatory Affairs Manager |
| Phone/Fax: | 916-374-3330/916-374-3144 |
| Date prepared: | July 24, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Vancomycin |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci |
| including Streptococcus pneumoniae | |
| Predicate device: | MicroScan MICroSTREP plus® Panel (K020822) |
510(k) Summary:
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/-1 °C in a non-CO2 incubator, and read according to the Package Insert.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.
The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an expected result generated on a CLSI frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003.
This Premarket Notification (510[k]) presents data in support of reading the MICroSTREP plus Panel with Vancomycin on the MicroScan® WalkAway instrument.
The external evaluation was conducted with stock and CDC Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation. The MICroSTREP plus® Panel demonstrated acceptable performance with an
1
overall Essential Agreement of 100% for Vancomycin instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Vancomcyin and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Vancomycin.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Shannon Popson Regulatory Affairs Manager Dade Behring, Inc. 2040 Enterprise Boulevard West Sacramento, CA 95691-9972
SEP - 1 2006
Re: K062290
Trade/Device Name: MicroScan MICroSTREP plus® Panel Vancomycin (0.06 - 8 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: July 24, 2006 Received: August 17. 2006
Dear Ms. Popson:
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).
3
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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). Other general information on your responsibilities under the Act may be obtained 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,
Sally, attorn
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
Indication for Use Statement
510(k) No.:
Device Name:
Intended Use
Indications for Use:
K062290 (To be assigned by FDA)
MicroScan MICroSTREP plus® Panel Vancomycin (0.06 - 8 mcg/ml)
To determine bacterial antimicrobial agent susceptibility
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument.
This particular submission is for the addition of instrument read capability of the antimicrobial Vancomycin, at concentrations of 0.06 to 8 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Vancomycin susceptibility testing in this panel are:
Streptococcus pneumoniae (including penicillin-resistant strains) Streptococcus pyogenes Streptococcus agalactiae the viridans group Streptococcus bovis
Prescription Use
(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
Page 1 of
Devices (OIVD)
Ludellie-Poole
Division Sign-On
Office of to Vites Dis guostic Device Evaluation and Sarely
vii
行 1 / 0 / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /