(62 days)
Not Found
No
The device description explicitly states that the panels are "read visually according to the Package Insert" and the MIC is "manually read by observing the lowest antimicrobial concentration showing inhibition of growth." There is no mention of automated analysis or any technology that would suggest AI/ML is involved.
No
The device is used to determine antimicrobial agent susceptibility, not to treat a condition. It provides information for diagnosis or guiding therapy, but is not therapeutic itself.
Yes
The device determines the susceptibility of bacteria to antimicrobial agents, which is a crucial step in diagnosing and guiding treatment for bacterial infections.
No
The device is a physical panel used for antimicrobial susceptibility testing, requiring incubation and visual reading. It is 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 on a sample taken from a patient (in this case, bacterial colonies grown from a sample).
- Device Description: The device description details a method for performing antimicrobial susceptibility testing using a miniaturized broth dilution method. This involves testing a biological sample (bacterial culture) in vitro (outside the body) to obtain diagnostic information.
- Performance Studies: The performance studies compare the device's performance to a reference method for determining antimicrobial susceptibility, which is a key characteristic of 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 clearly falls under 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. This particular submission is for the addition of the antimicrobial Ceftriaxone at concentrations of 0.015 to 8 mcg/ml to the test panel. The organisms which may be used for Ceftriaxone susceptibility testing in this panel are: Streptococcus pneumoniae, Streptococcus pyogenes, viridans group streptococci.
Product codes (comma separated list FDA assigned to the subject device)
JWY
Device Description
The MicroScan® MICroSTREP plus™ 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% bysed 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.
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
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.
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 MICroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 97.5% for Ceftriaxone when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Ceftriaxone.
Quality Control testing demonstrated acceptable results for Ceftriaxone.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement of 97.5% for Ceftriaxone
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
6 2002 Jun
Image /page/0/Picture/1 description: The image shows handwritten text that appears to be a code or identifier. The text includes the letters 'K' and 'O', followed by the numbers '2', '1', '1', and '0'. There is also a circle-like shape at the end of the text. The text is slightly tilted.
510(k) Summary Information:
| Device Manufacturer: | Dade MicroScan Inc. |
|---|---|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | April 3, 2002 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® MICroSTREP plus™ Panel |
| Intended Use: | To determine bacterial susceptibility to Ceftriaxone |
| 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™ 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% bysed 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.
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 Ceftriaxone.
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 MICroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 97.5% for Ceftriaxone when compared with the frozen Reference panel.
Reproducibility testing demonstrated acceptable reproducibility and precision with Ceftriaxone.
Quality Control testing demonstrated acceptable results for Ceftriaxone.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight, arranged in a row.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
6 2002 JUN
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
Re: K021110
Trade/Device Name: MicroScan® MICroSTREP plus™ Panels Antimicobial agent: Ceftriaxone Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: JWY Dated: April 3, 2002 Received: April 5, 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 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 Part 801); good manufacturing practice requirements as set
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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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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.: | KOZ1110
(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
Ceftriaxone at concentrations of 0.015 to 8 mcg/ml to the test panel |
| | The organisms which may be used for Ceftriaxone susceptibility
testing in this panel are: |
| | Streptococcus pneumoniae
Streptococcus pyogenes
viridans group streptococci |
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 | ||
| 310(k) Number | K021110 | |
| Prescription Use | ✓ | Over-The-Counter Use |
| (Per 21 CFR 801.109) | OR |
(Optional Format 1-2-96)