(317 days)
The MicroScan® rapID/S plus 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 gramnegative bacilli. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway®SI or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the AST portions can be read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Cephalothin, at concentrations of 0.5 to 32 µg/ml, to the test panel.
The gram-negative organisms which may be used for Cephalothin susceptibility testing in this panel are:
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
The MicroScan® Gram rapID/S plus Gram-Negative Panels with Cephalothin is not intended for use with:
Klebsiella oxytoca
Enterobacter spp.
Citrobacter freundii
Morganella morganii
Proteus vulgaris
Proteus penneri
Providencia spp
Serratia spp.
Yersinia enterolitica
Not Found
I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for a specific antimicrobial susceptibility testing panel.
It states that the device is "substantially equivalent" to legally marketed predicate devices, and lists the indications for use and the specific organisms for which Cephalothin susceptibility can be tested. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets, data provenance, or details on training sets.
- Information on the number or qualifications of experts, or adjudication methods for ground truth.
- Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
The letter generally references regulatory compliance and the intended use of the device but does not delve into the specifics of the underlying validation studies.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines that form a silhouette. The figure is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 3 0 2004
Mr. Robert Eusebio Manager Regulatory Affairs Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691
Re: K031601 Trade/Device Name: MicroScan® Synergies Plus Gram Negative MIC/Combo Panels with Cephalothin (0.5 - 32 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON, LRG, JWY, LTT, LTW Dated: July 30, 2004 Received: August 3, 2004
Dear Mr. Eusebio:
This letter corrects our substantially equivalent letter of April 2, 2004, regarding the trade name which was changed to MicroScan® Synergies Plus to better reflect the intended use of the device.
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 (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 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.
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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.
This letter will allow you to continue 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-3084. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Freddie lu. Paolo Actis
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 Statement
510(k) Number (if known): K031601
Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Cephalothin (0.5 - 32 µg/ml,)
Indications For Use:
Indications For Use: The MicroScan® rapID/S plus 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 gramnegative bacilli. After inoculation, panels are incubated for 4.5 - 18 hours at 35°C +/- 1°C, in a WalkAway®SI or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the AST portions can be read visually, according to the Package Insert.
This particular submission is for the addition of the antimicrobial Cephalothin, at concentrations of 0.5 to 32 µg/ml, to the test panel.
The gram-negative organisms which may be used for Cephalothin susceptibility testing in this panel are:
Escherichia coli Klebsiella pneumoniae Proteus mirabilis
The MicroScan® Gram rapID/S plus Gram-Negative Panels with Cephalothin is not intended for use with:
Klebsiella oxytoca Enterobacter spp. Citrobacter freundii Morganella morganii Proteus vulgaris
Proteus penneri Providencia spp Serratia spp. Yersinia enterolitica
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)
Fudith. Parte
Division Sign-Off
Page 1 of _ l
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_031601
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”