(73 days)
Not Found
No
The description focuses on traditional broth dilution susceptibility testing and visual or standard instrumentation reading, with no mention of AI/ML for interpretation or analysis.
No.
This device is designed to determine the susceptibility of bacteria to antimicrobial agents, which is a diagnostic function, not a direct treatment.
Yes
The device is used to determine quantitative and/or qualitative antimicrobial agent susceptibility, which is a diagnostic function to help understand the characteristics of bacterial colonies and aid in selecting appropriate treatments for infections.
No
The device description clearly states it is a "Dried Gram-Negative MIC/Combo Panel" which is a physical panel used for antimicrobial susceptibility testing. It is inoculated with a suspension and incubated, indicating a physical component. While it can be read with MicroScan instrumentation (which might involve software), the core device itself is a physical panel.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to determine antimicrobial agent susceptibility of bacterial colonies. This is a diagnostic test performed in vitro (outside the body) on a biological sample (bacterial colonies).
- Device Description: The description details a miniaturized broth dilution susceptibility test, which is a common method for in vitro diagnostic testing of microbial susceptibility.
- Performance Studies: The performance studies compare the device's performance to a reference panel, a standard practice for validating the accuracy and reliability of in vitro diagnostic tests. The metric used, "Essential Agreement," is also a common measure in AST (Antimicrobial Susceptibility Testing) which is a type of IVD.
The entire context of the document describes a device used to perform a diagnostic test on a biological sample in a laboratory setting, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To determine antimicrobial agent susceptibility.
The MicroScan® Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the addition of the antimicrobial gemifloxacin at concentrations of 0.002 to 16 mcg/ml to the test panel.
The gram-negative organisms which may be used for gemifloxacin susceptibility testing in this panel are:
Klebsiella pneumoniae
Klebsiella oxytoca
Proteus vulgaris
Product codes
LRG, JWY, LTT, LTW
Device Description
MicroScan® Dried Gram-Negative MIC/Combo Panels are in determing quatitizive MicroScan® Dried Gram-Negative MrC/Contibo Facils are designed for solid media of rapidly growing and of qualitative anaerobic Gram-Negative bacilli.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution usseentibility tost that have The antimicrobial susceptibility tests are intimations on all agents are diluted in broth to concentrations been diluted in broth and debydrated. Vallous and research incoulation with a standardized suspension of the organism. After inculation in a non-CO inculor for 16-20 hours, the minimum inhibitory suspension of the organism. After incuration in a not 007 more 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
The proposed MicroScan® Dried Gram-Negative MIC/Combo Panel demonstrated substantialy equivalent performance when compared with an NCCLS frozen Reference Party September Compares f performance when compared will all NCCCS trozed it Susceptibility Test (AST) Systems; Guidance for II Special Controls Guidance Document: Annuncroum Dasephoning 's 10[K]) presents data in support of Industry and PDA , autos Foor and vith Combo Panel with Gemifloxacin.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains The external evaluations was confirm the acceptability of the proposed Dried Gram-Negative The external evaluations were designed to commission in Challenge strains were Panel by comparing its performatic with an ACED to evaluation. The Dried Gram-Negative Panel compared to Expected Results determined prox to the evential Agreement of >98% for gemifloxacin when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with on to SCAN Inoculum and instrument reproducibulty testing demonstrated acceptable topicolours. And 2010.
gemifloxacin, regardless of which inoculum method (i.e., Turbidity and Prompt), and WalkAway®) was used.
Quality Control testing demonstrated acceptable results for gemifloxacin.
Key Metrics
Agreement of >98% for gemifloxacin when compared with the frozen Reference panel.
Predicate Device(s)
MicroScan Dried Gram-Negative and Gram-Positive MIC/Combo Panels
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
510(k) Summary
510(k) Submission Information:
| Device Manufacturer: | Dade Behring, Inc. |
|---|---|
| Contact name: | Cynthia Van Duker, Regulatory Affairs Manager |
| Fax: | 916-374-3144 |
| Date prepared: | December 17, 2003 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan® Dried Gram-Negative MIC/Combo Panels |
| Intended Use: | To determine antimicrobial agent susceptibility |
| 510(k) Notification: | New antimicrobial - Gemifloxacin |
| Predicate device: | MicroScan Dried Gram-Negative and Gram-Positive MIC/Combo Panels |
510(k) Summary:
ummary:
MicroScan® Dried Gram-Negative MIC/Combo Panels are in determing quatitizive MicroScan® Dried Gram-Negative MrC/Contibo Facils are designed for solid media of rapidly growing and of qualitative anaerobic Gram-Negative bacilli.
The antimicrobial susceptibility tests are miniaturizations of the broth dilution usseentibility tost that have The antimicrobial susceptibility tests are intimations on all agents are diluted in broth to concentrations been diluted in broth and debydrated. Vallous and research incoulation with a standardized suspension of the organism. After inculation in a non-CO inculor for 16-20 hours, the minimum inhibitory suspension of the organism. After incuration in a not 007 more antimicrobial concentration showing inhibition of growth.
The proposed MicroScan® Dried Gram-Negative MIC/Combo Panel demonstrated substantialy equivalent The proposed Microscan® Dried Cranel Reference Panel, as defined in the FDA document Class
performance when compared with an NCCLS frozen Reference Party September Compares f performance when compared will all NCCCS trozed it Susceptibility Test (AST) Systems; Guidance for II Special Controls Guidance Document: Annuncroum Dasephoning 's 10[K]) presents data in support of Industry and PDA , autos Foor and vith Combo Panel with Gemifloxacin.
The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains The external evaluations was confirm the acceptability of the proposed Dried Gram-Negative The external evaluations were designed to commission in Challenge strains were Panel by comparing its performatic with an ACED to evaluation. The Dried Gram-Negative Panel compared to Expected Results determined prox to the evential Agreement of >98% for gemifloxacin when compared with the frozen Reference panel.
Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with on to SCAN Inoculum and instrument reproducibulty testing demonstrated acceptable topicolours. And 2010.
gemifloxacin, regardless of which inoculum method (i.e., Turbidity and Prompt), and WalkAway®) was used.
Quality Control testing demonstrated acceptable results for gemifloxacin.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 three stripes forming its body and wings. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A."
Public Health Service
MAR - 1 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Cynthia Van Duker Regulatory Affairs Manager Dade MicroScan Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
Re: K033948
Trade/Device Name: MicroScan® Dried Gram-Negative MIC/Combo Panels with Gemifloxacin (0.002-16 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LRG, JWY, LTT, LTW Dated: December 17, 2003 Received: December 29, 2003
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Salamat
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
3
Indications for Use
510(k) Number (if known): K033948
MicroScan® Dried Gram-Negative MIC/Combo Panels with Gemifloxacin Device Name: (0.002 - 16 mcg/ml)
Indications For Use:
. .
The MicroScan® Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.
This particular submission is for the addition of the antimicrobial gemifloxacin at concentrations of 0.002 to 16 mcg/ml to the test panel.
The gram-negative organisms which may be used for gemifloxacin susceptibility testing in this panel are:
Klebsiella pneumoniae Klebsiella oxytoca Proteus vulgaris
Prescription Use र (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 Poole
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KD33948