(73 days)
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
MicroScan® Dried Gram-Negative MIC/Combo Panels 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 susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations used to determine minimum inhibitory concentrations (MICs) and research concentrations. The panels are inoculated with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration showing inhibition of growth.
The provided text describes the 510(k) submission for the MicroScan® Dried Gram-Negative MIC/Combo Panels with the addition of gemifloxacin. It focuses on demonstrating substantial equivalence to a predicate device for determining antimicrobial agent susceptibility.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for substantial equivalence) | Reported Device Performance |
|---|---|
| Substantially equivalent performance to NCCLS frozen Reference Panel (defined in FDA's AST Systems Guidance) | The proposed MicroScan® Dried Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel. |
| Essential Agreement (for gemifloxacin) | >98% for gemifloxacin when compared with the frozen Reference panel. |
| Reproducibility and precision | Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with gemifloxacin, regardless of inoculum method (Turbidity or Prompt) and instrument (WalkAway®). |
| Quality Control (QC) results | Quality Control testing demonstrated acceptable results for gemifloxacin. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The text mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for external evaluation, but does not specify the exact number of isolates or strains (sample size).
- Data Provenance: The text does not specify the country of origin. The study appears to be prospective in nature, as it describes "external evaluation" and "reproducibility testing" specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not specify the number or qualifications of experts used to establish the ground truth. It states that "Expected Results determined prior to the evaluation" were used for comparison. The ground truth is effectively the performance of the NCCLS frozen Reference Panel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe an adjudication method for the test set. The comparison is made against "Expected Results determined prior to the evaluation" which are established by the NCCLS frozen Reference Panel.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a device for determining antimicrobial susceptibility, not for image interpretation or human-in-the-loop assistance. The device can be read visually, but the study focuses on the device's performance against a reference method, not an improvement in human reading.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The study described is essentially a standalone performance evaluation of the MicroScan® Dried Gram-Negative MIC/Combo Panels with gemifloxacin. While the panels can be read visually, the evaluation focuses on the device's ability to produce accurate MIC results compared to a reference method, regardless of the reading method (visual or MicroScan instrumentation, like WalkAway®). The "algorithm" here is the system's ability to determine the MIC.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was the results obtained from an NCCLS frozen Reference Panel. This is a recognized standard method for antimicrobial susceptibility testing. The text refers to these as "Expected Results determined prior to the evaluation."
8. The sample size for the training set
The document does not mention a training set or its sample size. This type of device (antimicrobial susceptibility panel) is not typically developed using machine learning models that require distinct training and test sets in the same way an AI diagnostic algorithm would. The development involves established microbiological methods and reagents.
9. How the ground truth for the training set was established
As there is no explicit mention of a training set in the context of machine learning, this question is not applicable based on the provided text. The "ground truth" (NCCLS frozen Reference Panel results) is used for comparison in the evaluation, which serves as the "test set" in this context.
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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.
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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.
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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
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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
§ 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).