(22 days)
Not Found
No
The document describes a traditional broth dilution susceptibility test read visually or by an instrument, with no mention of AI or ML.
No.
This device is designed to determine antimicrobial agent susceptibility, which aids in diagnosis and treatment selection, but it does not directly treat a disease or condition itself.
Yes
This device determines the antimicrobial susceptibility of bacterial colonies, which is a diagnostic procedure used to guide treatment decisions for infections.
No
The device description explicitly mentions physical panels, incubation in a non-CO2 incubator, and the option of being read by a MicroScan WalkAway instrument, indicating hardware components are involved. The submission is specifically for adding instrument read capability for a particular antimicrobial on an existing panel.
Based on the provided text, 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 classic example of an in vitro diagnostic test, as it analyzes a sample (bacterial colonies) outside of the body to provide information about a patient's condition (susceptibility to antibiotics).
- Device Description: The description details a "miniaturization of the broth dilution susceptibility test," which is a laboratory method for determining the minimum inhibitory concentration (MIC) of an antimicrobial agent. This process involves handling and analyzing biological samples in a laboratory setting.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K021188) and the name "MicroScan® MICroSTREP plus® Panel" strongly indicates that this is a submission for a medical device, specifically an IVD, seeking regulatory clearance (likely a 510(k) submission in the US). Predicate devices are used to demonstrate substantial equivalence for new devices, a common process for IVDs.
- Performance Studies: The description of performance studies comparing the device's results to "Expected Results determined before the evaluation" and referencing an FDA guidance document for "Antimicrobial Susceptibility Test (AST) Systems" further confirms its nature as an IVD undergoing regulatory review.
The device performs a test on a biological sample (bacterial colonies) in a laboratory setting to provide diagnostic information about the susceptibility of those bacteria to antimicrobial agents. This aligns perfectly with 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 Cefepime, at concentrations of 0.015 - 8 mcg/ml on the MicroScan MICroSTREP plus® Panel. The organisms which may be used for Cefepime susceptibility testing on this panel are: Streptococcus pneumoniae Streptococcus pyogenes (Lancefield's Group A streptococci) Streptococcus agalactiae (Lancefield's Group B streptococci) Viridans group streptococci
Product codes (comma separated list FDA assigned to the subject device)
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, andiniteroofal agent subceptions, or versite = culation, 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. I ho annimer only case of at a started in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Muellereontoont one origing the with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, rfinen orolation 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
The evaluations were conducted with stock and CDC Challenge strains. The 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Performance evaluation
Sample Size: Not provided
Key Results: The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of 95.7% for Cefepime instrument read results compared with the Expected Result. Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Cefepime and the WalkAway® instrument. Quality Control testing demonstrated acceptable results for Cefepime.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: 95.7% (for Cefepime instrument read results compared with the Expected Result)
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® MICroSTREP plus® Panel (K021188)
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
510(k) Summary Information:
| Device Manufacturer: Dade Behring Inc. | |||
|---|---|---|---|
| Contact name: | May Morishima, Regulatory Affairs Administrator | NOV - 1 2006 | |
| Phone/Fax: | 916-374-2006/916-374-3144 | ||
| Date prepared: | October 4, 2006 | ||
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels | ||
| Trade Name: | MicroScan MICroSTREP plus® Panel | ||
| Intended Use: | To determine bacterial susceptibility to Cefepime | ||
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci | ||
| including Streptococcus pneumoniae | |||
| Predicate device: | MicroScan® MICroSTREP plus® Panel (K021188) |
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, andiniteroofal agent subceptions, or versite = culation, 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. I ho annimer only case of at a started in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Muellereontoont one origing the with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, rfinen orolation 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 I ho propoted mixalent 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 Cefepime on the MicroScan® WalkAway instrument.
1
The evaluations were conducted with stock and CDC Challenge strains. The 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 95.7% for Cefepime instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Cefepime and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Cefepime.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The logo is in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. May Morishima Regulatory Affairs Administrator Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
NOV - 1 2006
Re: K063099
Trade/Device Name: MicroScan MICroSTREP plus® Panel Cefepime (0.015 - 8 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: October 4, 2006 Received: October 11, 2006
Dear Ms. Morishima:
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, autum
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.: | K063099
(To be assigned by FDA) |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | MicroScan MICroSTREP plus® Panel
Cefepime (0.015 - 8 mcg/ml) |
| 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 Cefepime, at concentrations of
0.015 - 8 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Cefepime susceptibility testing
on this panel are:
Streptococcus pneumoniae
Streptococcus pyogenes (Lancefield's Group A streptococci)
Streptococcus agalactiae (Lancefield's Group B streptococci)
Viridans group streptococci |
| 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 Tu. Poole
Division Sign-Off
Page 1 of _1
Office of In Vitro Diagnostic Device Evaluation and Safety