(130 days)
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Unknown
The summary mentions "pattern recognition software," which could be implemented using AI/ML techniques, but it's not explicitly stated or detailed enough to confirm.
No
The document states the device is intended to "aid in the identification of Bacillus anthracis". This indicates a diagnostic purpose, not a therapeutic one.
Yes
The device is intended to aid in the identification of a specific pathogen, which falls under the definition of a diagnostic purpose.
No
The summary describes a system that uses gas chromatography to analyze bacterial samples and then applies pattern recognition software. Gas chromatography is a hardware-based analytical technique, indicating the system includes hardware components beyond just software.
Yes, based on the provided information, the MIDI Sherlock Microbial Identification System for BioDef™ is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is "intended to aid in the identification of Bacillus anthracis through the analysis of membrane fatty acids derived from cultured bacterial samples". This involves testing samples in vitro (outside of the living body) to provide diagnostic information.
- Sample Type: The system analyzes "cultured bacterial samples," which are biological specimens processed in vitro.
- Method: The method used is "gas chromatography and pattern recognition software" applied to these in vitro samples.
The core function of the device is to perform a test on a biological sample in vitro to provide information for diagnostic purposes (identifying a specific pathogen). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MIDI Sherlock Microbial Identification System for BioDef™ is intended to aid in the identification of Bacillus anthracis through the analysis of membrane fatty acids derived from cultured bacterial samples, using gas chromatography and pattern recognition software.
Product codes
NWZ, KZQ, NPO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3045 In vitro diagnostic device for
Bacillus spp. detection.(a)
Identification. An in vitro diagnostic device forBacillus species (spp.) detection is a prescription device used to detect and differentiate amongBacillus spp. and presumptively identifyB. anthracis and otherBacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused byBacillus spp. This device may consist ofBacillus spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to presumptively identify bacillus-like organisms in clinical specimens; bacteriophage used for differentiatingB. anthracis from otherBacillus spp. based on susceptibility to lysis by the phage; or antigens used to identify antibodies toB. anthracis (anti-toxin and anti-capsular) in serum. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused byB. anthracis, and gastrointestinal disease and non-gastrointestinal infections caused byB. cereus. (b)
Classification. Class II (special controls). The special controls are set forth in FDA's special controls guideline document entitled “In Vitro Diagnostic Devices forBacillus spp. Detection; Class II Special Controls Guideline for Industry and Food and Drug Administration Staff.” For availability of the guideline document, see § 866.1(e).(c)
Restriction on Distribution. The distribution of these devices is limited to laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities.(d)
Restriction on Use. The use of this device is restricted to prescription use and must comply with the following:(1) The device must be in the possession of:
(i)(A) A person, or his agents or employees, regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of such device; or
(B) A practitioner, such as a physician, licensed by law to use or order the use of such device; and
(ii) The device must be sold only to or on the prescription or other order of such practitioner for use in the course of his professional practice.
(2) The label of the device shall bear the statement “Caution: Federal law restricts this device to sale by or on the order of a ____”, the blank to be filled with the word “physician” or with the descriptive designation of any other practitioner licensed by the law of the State in which he practices to use or order the use of the device.
(3) Any labeling, as defined in section 201(m) of the Federal Food, Drug, and Cosmetic Act, whether or not it is on or within a package from which the device is to be dispensed, distributed by, or on behalf of the manufacturer, packer, or distributor of the device, that furnishes or purports to furnish information for use of the device contains adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented. This information will not be required on so-called reminder-piece labeling which calls attention to the name of the device but does not include indications or other use information.
(4) All labeling, except labels and cartons, bearing information for use of the device also bears the date of the issuance or the date of the latest revision of such labeling.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 7 2006
Mr. William Stimson Quality Assurance/Compliance Manager MIDI Inc. 125 Sandy Drive Newark, DE 19713
Re: K052485
Trade/Device Name: MIDI Sherlock Microbial Identification System BioDef™ Regulation Number: Unclassified Product Code: NWZ, KZQ, NPO Dated: December 8, 2005 Received: December 9, 2005
Dear Mr. Stimson:
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).
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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 (240)276-0484. 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/industry/support/index.html
Sincerely yours,
Sale, a Forg
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): K052485
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The MIDI Sherlock Microbial Identification System for BioDef™ is intended to aid in the identification of Bacillus anthracis through the analysis of membrane fatty acids derived from cultured bacterial samples, using gas chromatography and pattern recognition software.
Warnings:
- The Sherlock BioDef system is not intended for use with spore preparations or materials . other than colonies from trypticase soy agar (with 5% defibrinated sheep blood) that have been presumptively identified as Bacillus spp. BioDef cannot assess presence or absence of virulence factors.
- Accurate identification of B. anthracis is dependent on purity of isolates, length of incubation . (24 h) at 35° C, and media type, along with well-trained and experienced technicians. Only BBL™ 5% sheep blood agar has been validated for identifying B. anthracis with the MIDI Sherlock Microbial Identification System for BioDef™.
- The definitive identification of B. anthracis from colony growth requires additional testing . and confirmation procedures in consultation with public health or other authorities to whom reporting is required.
- Identification of organisms other than B. anthracis in the Sherlock BioDef's system's BTR . library database has not been evaluated.
Prescription Use ४ (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)
FruaRund
Division Sign-Off
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Kos2485 510(k)_