(74 days)
None
Not Found
No
The summary describes a traditional immunofluorescence assay and does not mention any AI or ML components.
No
The device is a diagnostic screening test used for the detection of respiratory viruses, it does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that the device is a "screening test for the presumptive detection of respiratory viruses," which is a diagnostic purpose.
No
The device is described as a qualitative indirect immunofluorescence screening test, which inherently involves physical reagents and laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "qualitative indirect immunofluorescence screening test for the presumptive detection of respiratory viruses... in respiratory specimens (nasopharyngeal aspirates) and in cell cultures." This describes a test performed on samples taken from the human body to provide information about a person's health status (in this case, the presence of respiratory viruses).
- Anatomical Site: It specifies testing on "respiratory specimens (nasopharyngeal aspirates)," which are samples taken from the human body.
- Intended User / Care Setting: It indicates use in "laboratories where qualified technicians are familiar with routine indirect immunofluorescence testing for microbiological diagnosis," which is a typical setting for IVD testing.
- Performance Studies: The description of performance studies mentions evaluation against other diagnostic methods ("Bartels Viral Respiratory Screening and Identification Kit and standard viral isolation reference methods"), further confirming its role in diagnosis.
The core function of the device is to analyze biological samples in vitro (outside the body) to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMAGEN™ Respiratory Screen is a qualitative indirect immunofluorescence screening test for the presumptive detection of respiratory viruses; Respiratory Syncytial Virus (RSV). Influenza A and B. Parainfluenza types 1. 2 and 3 and Adenovirus in respiratory specimens (nasopharyngeal aspirates) and in cell cultures.
Product codes
GNW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories where qualified technicians are familiar with routine indirect immunofluorescence testing for microbiological diagnosis.
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
Performance characteristics for the additional intended uses have been established by external clinical evaluation against the Bartels Viral Respiratory Screening and Identification Kit and standard viral isolation reference methods used for screening for the presence of respiratory viruses.
Summary of Performance Studies
external clinical evaluation against the Bartels Viral Respiratory Screening and Identification Kit and standard viral isolation reference methods used for screening for the presence of respiratory viruses.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3330 Influenza virus serological reagents.
(a)
Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
7473454
ITEM 2
DEC 22 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
The proposed changes to the intended use of IMAGEN™ Respiratory Screen outlined n this supplementary information have no effect on the safety and effectiveness of the IMAGENTM Respiratory Screen product, as outlined in the original submission.
Performance characteristics for the additional intended uses have been established by external clinical evaluation against the Bartels Viral Respiratory Screening and Identification Kit and standard viral isolation reference methods used for screening for the presence of respiratory viruses. (Exhibit E)
IMAGEN™ Respiratory Screen is intended for use in laboratories where qualified technicians are familiar with routine indirect immunofluorescence testing for microbiological diagnosis. However specific quality control information regarding the validity of test results is included in the Product Insert, to facilitate reliable and reproducible results and minimise the occurrence of false positive or false negative results. Procedures include the use of positive and negative control slides, a negative control reagent and specifications for acceptable results. Technical references and a Customer Services phone number are provided to aid the user in further troubleshooting.
IMAGEN™ Respiratory Screen is similar in use and technology to Bartel's Viral Respiratory Screening and Identification Kit, which is already in commercial distribution in the U.S.
Further information regarding the safety and effectiveness of IMAGEN™ Respiratory Screen will be made available within 30 days of request by any person. This information excludes confidential patient information and proprietary manufacturing procedures pertinent to this device. Please contact:
Dr Elisabeth Silver, Requlatory Affairs Manager, DAKO Limited, Denmark House, Angel Drove. Elv. Cambridgeshire, CB7 4ET, UK.
Phone(353) 669911 Fax
Signature: Elisabeth She Date: 17th September 1997
E.A SILVER
1
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 2 1997
Elisabeth A. Silver, Ph.D. Regulatory Affairs Manager DAKO Diagnostics Ltd. Denmark House Angel Drove, Elv Cambridgeshire CB7 4ET England, United Kingdom
Re: K973954
Trade Name: IMAGEN™ Respiratory Screen Regulatory Class: I Product Code: GNW Dated: September 22, 1997 Received: October 9, 1997
Dear Dr. Silver:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
ITEM 5
INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number: Supplement to K962037
IMAGEN™ RESPIRATORY SCREEN Device Name:
Indications for Use: The IMAGEN™ Respiratory Screen is a qualitative indirect immunofluorescence screening test for the presumptive detection of respiratory viruses; Respiratory Syncytial Virus (RSV). Influenza A and B. Parainfluenza tvpes 1. 2 and 3 and Adenovirus in respiratory specimens (nasopharyngeal aspirates) and in cell cultures.
Signature: Elisabeth Silva
Date: Ith September 1997
E A SILVER, Ph.D. Regulatory Affairs Manager
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
.............................................................................................................................................................................. Concurrence of CDRH, Office of Device Evaluation (ODE)
John Ticehurst 12/19/97
John Ticehurst MT
Interim Chief, Microbiology Branch
Prescription Use V (Per 21 CFR 801.109)
or
Over-the-Counter Use (Optional Format 1-2-96)