(74 days)
Not Found
No
The device description explicitly states that the minimum inhibitory concentration (MIC) is "manually read by observing the lowest antimicrobial concentration showing inhibition of growth." There is no mention of automated analysis, algorithms, or machine learning.
No
The device is used to determine antimicrobial agent susceptibility, which aids in diagnosis and treatment selection, but it does not directly provide therapy.
Yes
The device determines the susceptibility of bacteria to antimicrobial agents, which is a diagnostic function used to guide treatment decisions for bacterial infections.
No
The device description clearly outlines a physical panel that is inoculated with a bacterial suspension, incubated, and then visually read. This involves physical components and processes, not solely software.
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 in vitro (outside the body) on a biological sample (bacterial colonies grown on solid media).
- Device Description: The description details a laboratory test method (broth dilution susceptibility test) performed on a panel containing various antimicrobial agents. This is a typical format for an IVD used in clinical microbiology laboratories.
- Performance Studies: The performance studies compare the device's results to a "frozen Reference panel," which is a standard practice for evaluating the accuracy of IVD devices.
- Predicate Device: The mention of a "Predicate Device" (K963641; MicroScan® Streptococcus MIC Panel) indicates that this device is being compared to a previously cleared IVD device, further confirming its classification as an IVD.
The device is designed to provide information about the susceptibility of bacteria to antimicrobial agents, which is crucial for guiding treatment decisions for infections. This falls squarely within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: To determine bacterial susceptibility to Chloramphenicol
Indication for Use: For determining antimicrobic susceptibility with aerobic streptococci, including Streptococcus pneumoniae
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.
This particular submission is for the addition of the antimicrobial Chloramphenicol at concentrations of 1 to 32 mcg/ml to the test panel. The organisms which may be used for Chloramphenicol susceptibility testing in this panel are: Susceptible streptococci, including Streptococcus pneumoniae
Product codes (comma separated list FDA assigned to the subject device)
JWY
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 visually 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 (MC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
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)
The proposed MicroScan® MICroSTREP plus™ Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000.
The Premarket Notification (510[k]) presents data in support of the new MICroSTREP plus™ Panel with Chloramphenicol.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus™ Panel by comparing its performance with an NCCLS frozen Reference panel. The MCroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 100% for Chloramphenicol when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Chloramphenicol.
Quality Control testing demonstrated acceptable results for Chloramphenicol.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 100% for Chloramphenicol
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.
MicroScan® Streptococcus MIC Panel (K963641).
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.
Not Found
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
§ 866.1640 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
JUN 11 2002
510(k) Summary Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | March 26, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus™ Panel |
| Intended Use: | To determine bacterial susceptibility to Chloramphenicol |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci, including |
| Streptococcus pneumoniae | |
| Predicate device: | MicroScan® Streptococcus MIC Panel (K963641). |
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 visually 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 (MC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth.
The proposed MicroScan® MICroSTREP plus™ Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000.
The Premarket Notification (510[k]) presents data in support of the new MICroSTREP plus™ Panel with Chloramphenicol.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed MICroSTREP plus™ Panel by comparing its performance with an NCCLS frozen Reference panel. The MCroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 100% for Chloramphenicol when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Chloramphenicol.
Quality Control testing demonstrated acceptable results for Chloramphenicol.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three wavy lines representing the body and head. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 1 2002
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
Re: K021018
Trade/Device Name: MicroScan® MICroSTREP plus™ Panels For Chloramphenicol Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: JWY Dated: March 26, 2002 Received: March 29, 2002
Dear Ms. Van Duker:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 dctermination 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 Part 801); good manufacturing practice requirements as set
2
Page 2 -
This letter will allow you to begin marketing your device as described in your 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 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indication for Use Statement
・
| 510(k) No.: | KOZ1018
(To be assigned by FDA) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MicroScan ® MICroSTREP plus ™ Panel |
| 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. |
This particular submission is for the addition of the antimicrobial Chloramphenicol at concentrations of 1 to 32 mcg/ml to the test panel
The organisms which may be used for Chloramphenicol susceptibility testing in this panel are:
Susceptible streptococci, including Streptococcus pneumoniae
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Clinical Laboratory Devices | ||
| 510(k) Number | K021018 | |
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
(Optional Format 1-2-96)