(26 days)
Not Found
No
The summary describes a traditional broth dilution susceptibility test read manually or by an instrument, with no mention of AI/ML in the device description or performance studies.
No.
This device is an in-vitro diagnostic (IVD) device used to determine bacterial antimicrobial agent susceptibility, not to treat a disease.
Yes
The device determines bacterial antimicrobial agent susceptibility, which is a diagnostic function to help guide treatment decisions by identifying effective antimicrobial agents.
No
The device description explicitly mentions physical panels, incubation in a non-CO2 incubator, and the use of a MicroScan® WalkAway instrument, all of which are hardware components. The submission is for adding instrument read capability to an existing hardware-based system.
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 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 how the panel is used to perform miniaturized broth dilution susceptibility tests on bacterial isolates. This process involves analyzing a biological sample (bacteria) in a laboratory setting.
- Performance Studies: The performance studies compare the device's results to "Expected Results" and a "CLSI frozen Reference Panel," which are standard practices for evaluating the accuracy of diagnostic tests.
- Key Metrics: The use of "Essential Agreement" as a key metric is common in the evaluation of diagnostic tests, particularly for antimicrobial susceptibility testing.
The device is designed to be used in vitro (outside the body) to diagnose or provide information about a disease or condition (bacterial infection and its susceptibility to treatment).
N/A
Intended Use / Indications for Use
To determine bacterial susceptibility to Clarithromycin
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℃ +/- 1℃ 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 Clarithromycin, at concentrations of 0.06 - 2 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Clarithromycin susceptibility testing on this panel are:
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus agalactiae
Streptococci (Groups C, F, G)
viridans group streptococci
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 ℃ 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 µl 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
Prescription Use
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: External evaluation, Instrument reproducibility testing, Quality Control testing.
Key Results: The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of 98.6% for Clarithromycin instrument read results compared with the Expected Result. Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Clarithromycin and the WalkAway® instrument. Quality Control testing demonstrated acceptable results for Clarithromycin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Essential Agreement: 98.6%
Predicate Device(s)
MicroScan® MICroSTREP plus® Panel
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
NOV 2 7 200E
510(k) Summary Information:
| Device Manufacturer: | Dade Behring Inc. |
|---|---|
| Contact name: | May Morishima, Regulatory Affairs Administrator |
| Phone/Fax: | 916-374-2006/916-374-3144 |
| Date prepared: | October 11, 2006 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan MICroSTREP plus® Panel |
| Intended Use: | To determine bacterial susceptibility to Clarithromycin |
| Indication for Use: | For determining antimicrobic susceptibility with aerobic streptococci |
| including Streptococcus pneumoniae. | |
| Predicate device: | MicroScan® MICroSTREP plus® Panel |
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 ℃ 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 µl 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 Clarithromycin 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.
1
The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agrecment of 98.6% for Clarithromycin instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Clarithromycin and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Clarithromycin.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and three horizontal lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 27 2006
Ms. May Morishima Dade Behring Inc. Microscan 2040 Enterprise Blvd West Sacramento, CA 95691
Re: K063299
Trade/Device Name: MicroScan MICroSTREP plus® Panel Clarithromycin (0.06 – 2 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: LRG, LTT Dated: October 11, 2006 Received: November 1, 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 FFA may publish further announcements concerning your device in the Federal Degister.
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. Your 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 10gally marketed predicate device results in a classification for your device and thus, perror to 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 tollified non ber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Sally, artm
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.:
K063299 (To be assigned by FDA)
MicroScan MICroSTREP plus® Panel Clarithromycin (0.06 -- 2 mcg/ml)
Intended Use
Device Name:
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℃ +/- 1℃ 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 Clarithromycin, at concentrations of 0.06 - 2 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Clarithromycin susceptibility testing on this panel are:
Streptococcus pneumoniae Streptococcus pyogenes Streptococcus agalactiae Streptococci (Groups C, F, G) 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)
Freddi tu. Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 1
KD6329fi
viii