(26 days)
Not Found
No
The device description details a process based on basic colorimetry and pre-programmed calibration curves, with no mention of AI or ML techniques.
No
The device is an in vitro diagnostic device used to measure the optical density of microorganism suspensions, providing values in McFarland units, which are proportional to microorganism concentrations. It does not directly treat or diagnose a disease in a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The DensiChek™ Plus has applications as an in vitro diagnostic device."
No
The device description clearly details hardware components such as an LED light source, an interference filter, and the instrument itself, which performs colorimetry measurements.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The DensiChek™ Plus has applications as an in vitro diagnostic device."
- Function: The device measures the optical density of a microorganism suspension to determine its concentration in McFarland units. This is a crucial step in preparing samples for downstream diagnostic tests, such as those performed by the VITEK® and VITEK® 2 Systems, which are themselves IVD systems used for identifying microorganisms and determining their susceptibility to antimicrobial agents.
- Context of Use: The device is intended for use with the VITEK® and VITEK® 2 Systems, which are diagnostic platforms used in clinical laboratories to aid in the diagnosis and treatment of infectious diseases.
- Measurement of Biological Sample: The device measures the turbidity of a suspension containing microorganisms, which are biological entities.
Therefore, based on the explicit statement and its function within the context of diagnostic testing, the DensiCHEK™ Plus instrument is an In Vitro Diagnostic device.
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
LON
Device Description
DensiCHEK100 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. 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 medical device.
The DensiCHEK Plus generates a McFarland 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 Ir = 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
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory technician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The DensiCHEK Plus modified device, to include VITEK 2 AST-YS as a product applicable for use with this device, demonstrated substantially equivalent performance during risk assessment studies when compared with the DensiCHEK Plus unmodified device cleared under K083536. Performance with VITEK 2 AST-YS and DensiCHEK Plus has now been established. This Special 510(k) Device Modification presents data in support of DensiCHEK Plus labeling change to add VITEK 2 AST-YS to the list of applicable products for which it can be used to aid in microorganism suspension prepration.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
0
BIOMÉ R ! E U X
510(k) SUMMARY
DensiCHEK™ Plus Special 510(k): Device Modification
NOV - 9 2009
510(k) Submission Information:
Submitter's Name: Address:
Contact Person:
Phone Number:
Fax Number:
Date of Preparation:
B. Device Name:
Formal/Trade Name:
Classification Name:
October 13, 2009
bioMérieux, Inc.
John Tenllado
314 -731-8386
314-731-8689
595 Anglum Road Hazelwood, MO 63042
Senior Manager, Regulatory Affairs
DensiCHEK™ Plus
DensiCHEK Plus
Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Device, 21 CFR 866.1645
Common Name:
C. Predicate Device:
DensiCHEK Plus (K083536)
D. 510(k) Summary:
DensiCHEK100 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. 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 medical device.
The intended use of the DensiCHEK Plus, as described in its labeling (DensiCHEK Plus Instrument User Manual), has not changed as a result of this modification to add VITEK 2 AST-YS to the list of products appropriate for use with DensiCHEK Plus now that performance has been established. This modification does not affect the fundamental scientific technology of this device. The device design was not altered in any way.
The DensiCHEK Plus generates a McFarland 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)
bioMérieux, Inc.
595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: 314/731-8500 800/638-4835 Fax: 314/731-8700
1
Where:
T = Transmittance
Ir = 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.
The DensiCHEK Plus modified device, to include VITEK 2 AST-YS as a product applicable for use with this device, demonstrated substantially equivalent performance during risk assessment studies when compared with the DensiCHEK Plus unmodified device cleared under K083536. Performance with VITEK 2 AST-YS and DensiCHEK Plus has now been established. This Special 510(k) Device Modification presents data in support of DensiCHEK Plus labeling change to add VITEK 2 AST-YS to the list of applicable products for which it can be used to aid in microorganism suspension prepration.
2
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 eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Jolyn Tenllado Senior Manager, Regulatory Affairs bioMerieux, Inc. 595 Anglum Road . Hazelwood, MO 63042
Re: K093224
Trade/Device Name: DensiCHEKTM Plus Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility device Regulatory Class: Class II Product Code: LON
9 2009
NOV
Dated: October 13, 2009 Received: October 14, 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, listing 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.
3
Page 2 - Ms. Tenllado
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); medical device 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) 796-5680 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sazastopns
Sally A. Hojvat, Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known):_ 1093 and
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 th. Poole
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093224
p. 36