(25 days)
No
The summary describes a standard antimicrobial susceptibility testing system and its performance characteristics. There is no mention of AI or ML in the intended use, device description, or performance studies. The "instrument read capability" refers to automated reading of the test results, not necessarily using AI/ML for interpretation.
No.
The device is used to determine the susceptibility of bacteria to antimicrobial agents, which is an in vitro diagnostic function, not a direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section states that the device is "used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci." This process of determining susceptibility to guide treatment is a diagnostic function.
No
The device description explicitly mentions a "MicroScan® WalkAway instrument" which is a piece of hardware used to incubate and read the panels. The submission is for adding instrument read capability, indicating reliance on this hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to "determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae." This is a diagnostic test performed in vitro (outside the body) on biological samples (bacterial colonies).
- Device Description: The description details a miniaturized broth dilution susceptibility test, which is a standard laboratory method for determining how effective antimicrobial agents are against specific bacteria. This process involves preparing and testing samples in a laboratory setting.
- Performance Studies: The performance studies focus on evaluating the accuracy of the device in determining antimicrobial susceptibility, comparing its results to an "Expected Result" determined by a predicate device. This type of evaluation is typical for IVD devices.
The device is designed to provide information about a patient's potential response to antimicrobial treatment by analyzing a sample of bacteria from that patient. 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 Penicillin
Indication for Use: For determining antimicrobic susceptibility with aerobic streptococci including Streptococcus pneumoniae
Product codes
LRG, LTT
Device Description
The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative I he Microbial agent susceptibility of colonies grown on solid media of aerobic streptococi, anumicronal agent susceptionity of octories growation, panels are incubated for 20 – 24 hours at meluding bireplocouss prominent.
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 the antimicrobial agents are diluted in water, buffer or minute concentrations of broth to various animilierooms are anatos are unterest. Panels are rehydrated with 115 ul Muellerconcentrations only the railige of % 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 After inculture in a non CO2 measures ead by observing the lowest antimicrobial concentration (IVIC) For the torganism 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 external evaluation was conducted with stock and CDC Challenge strains. The external I he external evaluation was confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined the MICros I KL. 'pris' I uner of company is Panel demonstrated acceptable performance with an overall Essential Agreement of 98.6% for Penicillin instrument read results compared with the Expected Result.
Summary of Performance Studies
The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated I I le proposed instrument read mone with streptococcal isolates when compared with an expected substantially cqurvalent performance was se Panel, as defined in the FDA document "Class II Special IControls 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 Penicillin on the MicroScan® WalkAway instrument.
The external evaluation was conducted with stock and CDC Challenge strains. The external I he external evaluation was confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined the MICros I KL. 'pris' I uner of company is Panel demonstrated acceptable performance with an overall Essential Agreement of 98.6% for Penicillin instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Penicillin and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Penicillin.
Key Metrics
Essential Agreement of 98.6% for Penicillin instrument read results compared with the Expected Result.
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
Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string appears to be "Ko62773". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with distinct shapes for each character.
510(k) Summary Information:
| Device Manufacturer: | Dade Behring Inc. | OCT 13 2006 |
|---|---|---|
| Contact name: | Libby Warriner, Regulatory Affairs | |
| Phone/Fax: | 916-374-3244/916-374-3144 | |
| Date prepared: | September 7, 2006 | |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels | |
| Trade Name: | MicroScan MICroSTREP plus® Panel | |
| Intended Use: | To determine bacterial susceptibility to Penicillin | |
| 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 I he Microbial agent susceptibility of colonies grown on solid media of aerobic streptococi, anumicronal agent susceptionity of octories growation, panels are incubated for 20 – 24 hours at meluding bireplocouss prominent.
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 the antimicrobial agents are diluted in water, buffer or minute concentrations of broth to various animilierooms are anatos are unterest. Panels are rehydrated with 115 ul Muellerconcentrations only the railige of % 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 After inculture in a non CO2 measures ead by observing the lowest antimicrobial concentration (IVIC) For the torganism 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 I le proposed instrument read mone with streptococcal isolates when compared with an expected substantially cqurvalent performance was se Panel, as defined in the FDA document "Class II Special IControls 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 Penicillin on the MicroScan® WalkAway instrument.
The external evaluation was conducted with stock and CDC Challenge strains. The external I he external evaluation was confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined the MICros I KL. 'pris' I uner of company is Panel demonstrated acceptable performance with
1
an overall Essential Agreement of 98.6% for Penicillin instrument read results compared with the Expected Result.
Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Penicillin and the WalkAway® instrument.
Quality Control testing demonstrated acceptable results for Penicillin.
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 the department's name in a circular arrangement around a symbol. The symbol is an abstract representation of a human figure, with three overlapping profiles facing to the right. The profiles are stylized and appear to be connected, possibly symbolizing unity or collaboration.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Libby Warriner Regulatory Affairs/Quality Systems Compliance Senior Specialist Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972
OCT 1 3 2006
Re: K062773 Trade/Device Name: MicroScan MICroSTREP plus® Panel Penicillin (0.015 to 16 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: September 7, 2006 Received: September 18, 2006
Dear Ms. Warriner:
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) I ms icter wif anow you'ls ought finding of substantial equivalence of your device to a legally premarket notification. "The sults 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, If you destions on the promotion and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240)276-0450. Also, please note the vitto Diagnostic Dories Drananding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information on Jour versational 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 .:
K062173 (To be assigned by FDA)
MicroScan MICroSTREP plus® Panel Penicillin (0.015 to 16 mcg/ml)
Intended Use
Device Name:
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.
To determine bacterial antimicrobial agent susceptibility
This particular submission is for the addition of instrument read capability of the antimicrobial Penicillin, at concentrations of 0.015 to 16 mcg/ml on the MicroScan MICroSTREP plus® Panel.
The organisms which may be used for Penicillin susceptibility testing on this panel are:
Streptococcus pneumoniae Streptococci (Groups A, C, G, H, L, and M) Streptococcus agalactiae Viridans 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 M. Poole
Division Sign-Off
Page 1 of __ 1
Office of In Vitro Diagnostic Device Evaluation and Sufety
K06 2773
viii