(287 days)
Not Found
No
The description details a device that uses basic colorimetry and a pre-programmed calibration curve to measure optical density. There is no mention of AI or ML algorithms for data processing or interpretation.
No
The device is an in vitro diagnostic device used to measure the optical density of microorganism suspensions, providing values in McFarland units. It does not directly treat or diagnose a disease or condition in a patient.
Yes
Explanation: The Intended Use/Indications for Use section explicitly states, "DensiChek™ Plus has applications as an in vitro diagnostic device," and the Device Description section reiterates, "The DensiCHEK Plus has applications as an in vitro diagnostic medical device."
No
The device description explicitly states "The DensiCHEK Plus generates a McFarrand value using basic colorimetry... The light source in the DensiCHEK plus is an LED... and an interference filter is used between the LED and the test tube". This indicates the device includes physical hardware components (LED, filter) for measurement, not just software.
Yes, based on the provided text, the DensiCHEK™ Plus instrument is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement in Intended Use/Indications for Use: The text explicitly states, "The DensiChek™ Plus has applications as an in vitro diagnostic device."
- Explicit Statement in Device Description: The text also states, "The DensiCHEK Plus has applications as an in vitro diagnostic medical device."
- Functionality: The device measures the optical density of a microorganism suspension to provide McFarland units, which are used in conjunction with the VITEK® and VITEK® 2 Systems for identification and susceptibility testing of microorganisms. This process is a key component of in vitro diagnostic procedures in microbiology.
N/A
Intended Use / Indications for Use
The DensiCHEK™ Plus instrument is intended for use with the VITEK® and VITEK® 2 Systems to measure the optical density of a microorganism suspension. The instrument provides values in McFarland units, proportional to microorganism concentrations. DensiCHEK Plus is indicated for use with polystyrene and glass test tubes and the reading range is 0.0 - 4.0 McFarland. The DensiChek™ Plus has applications as an in vitro diagnostic device.
Product codes (comma separated list FDA assigned to the subject device)
LON
Device Description
DensiCHEK™ Plus is intended for use with the VITEK® and VITEK® 2 Systems to measure the optical density of a microorganism suspension. The instrument provides values in McFarland units, proportional to microorganism concentrations. The DensiCHEK Plus has applications as an in vitro diagnostic medical device.
The DensiCHEK Plus generates a McFarrand value using basic colorimetry, which is a method of measurement that relates the amount of color in a transparent medium (liquid) to the amount of a particular substance in the liquid. In general the concentration of the substance being measured is proportional to the intensity of the solution. The darker the color is, the higher the concentration. Absorbance (Abs) is a commonly used measure of the amount of light absorbed by the solution. Absorbance is given by: Abs = - log T or Abs = - log (1-10) Where: T = Transmittance I = Intensity of light transmitted through the sample 10 = Intensity of light entering the sample
The DensiCHEK Plus measures the turbidity of the saline and microorganism suspension using a single wavelength, 580 nm. The absorption of light determines the McFarland value generated by the instrument. The more turbid the suspension is, the higher the McFarland standard measurement. The light source in the DensiCHEK plus is an LED that emits a narrow range of wavelengths, and an interference filter is used between the LED and the test tube (sample) to further narrow the wavelength to 580 nm. There are 2 calibration curves pre-programmed into the DensiCHEK Plus, one for glass tubes and one for plastic tubes. The absorbance is different for glass and plastic, therefore the laboratory technician using the DensiCHEK Plus must choose the appropriate tube type setting for the inoculum suspension based on whether it was prepared in a glass or plastic test tube. The instrument is first zeroed using a test tube filled with saline (blank). The technician then places the well-mixed organism suspension into the instrument and slowly rotates the test tube. The instrument will display a series of dashes followed by a McFarland reading.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
DensiCHEK Plus demonstrated substantially equivalent performance when compared with the DensiChek in the performance equivalency study utilizing VITEK 2 Identification and Susceptibility cards and systems. This device also demonstrated acceptable acouracy, repeatability (within instrument variability) and reproducibility (between instrument variability) during validation. The Premarket Notification (510[k]) presents data in support of DensiCHEK Plus.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
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SEP 1 1 2009
Image /page/0/Picture/1 description: The image shows the word "BIOMERIEUX" in a stylized font. The letters are all capitalized and evenly spaced. Above the word is a black circle with some texture, possibly representing a logo or a design element associated with the brand.
510(k) SUMMARY
DensiCHEK™ Plus
510(k) Submission Information:
| Submitter's Name: |
|---|
| Address: |
| Contact Person: |
bioMérieux, Inc.
595 Anglum Road Hazelwood, MO 63042
Jolyn Tenllado Associate Staff Regulatory Affairs Specialist
314 -731-8386
314-731-8689
November 26, 2008
B. Device Name:
Formal/Trade Name:
Date of Preparation:
Phone Number:
Fax Number:
Classification Name:
DensiCHEK™ Plus
Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Device, 21 CFR 866. 1645
DensiCHEK Plus Common Name:
C. Predicate Device:
DensiChek (K050002, VITEK 2 Compact)
D. 510(k) Summary:
DensiCHEK™ Plus is intended for use with the VITEK® and VITEK® 2 Systems to measure the optical density of a microorganism suspension. The instrument provides values in McFarland units, proportional to microorganism concentrations. The DensiCHEK Plus has applications as an in vitro diagnostic medical device.
The DensiCHEK Plus generates a McFarrand value using basic colorimetry, which is a method of measurement that relates the amount of color in a transparent medium (liquid) to the amount of a particular substance in the liquid. In general the concentration of the substance being measured is proportional to the intensity of the solution. The darker the color is, the higher the concentration. Absorbance (Abs) is a commonly used measure of the amount of light absorbed by the solution. Absorbance is given by:
Abs = - log T or Abs = - log (1-10)
Where:
T = Transmittance
I = Intensity of light transmitted through the sample
10 = Intensity of light entering the sample
bioMérieux, Inc.
Fax: 314/731-800/638-4835 595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 8700
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The DensiCHEK Plus measures the turbidity of the saline and microorganism suspension using a single wavelength, 580 nm. The absorption of light determines the McFarland value generated by the instrument. The more turbid the suspension is, the higher the McFarland standard measurement. The light source in the DensiCHEK plus is an LED that emits a narrow range of wavelengths, and an interference filter is used between the LED and the test tube (sample) to further narrow the wavelength to 580 nm. There are 2 calibration curves pre-programmed into the DensiCHEK Plus, one for glass tubes and one for plastic tubes. The absorbance is different for glass and plastic, therefore the laboratory technician using the DensiCHEK Plus must choose the appropriate tube type setting for the inoculum suspension based on whether it was prepared in a glass or plastic test tube. The instrument is first zeroed using a test tube filled with saline (blank). The technician then places the well-mixed organism suspension into the instrument and slowly rotates the test tube. The instrument will display a series of dashes followed by a McFarland reading.
DensiCHEK Plus demonstrated substantially equivalent performance when compared with the DensiChek in the performance equivalency study utilizing VITEK 2 Identification and Susceptibility cards and systems. This device also demonstrated acceptable acouracy, repeatability (within instrument variability) and reproducibility (between instrument variability) during validation. The Premarket Notification (510[k]) presents data in support of DensiCHEK Plus.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Ms. Jolyn Tenllado Associate Director, Regulatory Affairs bioMérieux 595 Anglum Road Hazelwood, MO 63042
Re: K083536
Trade/Device Name: DensiPLUS TM Plus Regulation Number: 21 CFR 866.1645 Regulation Name: Short-Term Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: LON Dated: September 9, 2009 Received: September 10, 2009
SFP 1 1 2009
Dear Ms Tenllado:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), 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
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Page 2 - Ms. Weaver
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Lurdle Kai Poole, MS
for
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):
Device Name: DensiCHEK™ Plus
Indications For Use:
The DensiCHEK™ Plus instrument is intended for use with the VITEK® and VITEK® 2 Systems to measure the optical density of a microorganism suspension. The instrument provides values in McFarland units, proportional to microorganism concentrations. DensiCHEK Plus is indicated for use with polystyrene and glass test tubes and the reading range is 0.0 - 4.0 McFarland. The DensiChek™ Plus has applications as an in vitro diagnostic device.
Prescription Use × (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 L. Cooke
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
sin(k) K083536
K083536 Al p. 91