(37 days)
Not Found
No
The description focuses on a rapid chromatographic immunoassay for antigen detection, with no mention of AI or ML technologies.
No
This device is an in vitro diagnostic test for detecting RSV antigen, which is used to aid in the diagnosis of an infection, not to treat or directly restore health.
Yes
The intended use explicitly states "This test is intended for in vitro diagnostic use to aid in the diagnosis of Respiratory Syncytial Virus (RSV) infections".
No
The device description clearly indicates a "chromatographic assay" and mentions "specimens," which are physical components and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "This test is intended for in vitro diagnostic use".
- Device Description: It describes a "chromatographic assay to detect RSV antigens extracted from various specimens of symptomatic patients," which is a typical description of an in vitro diagnostic test.
- Intended User/Care Setting: It reiterates "in vitro diagnostic use".
The core function of the device is to analyze biological samples (nasopharyngeal washes, aspirates, swabs) outside of the body to aid in the diagnosis of a disease (RSV infection). This is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Directigen™ EZ RSV test is a rapid chromatographic immunoassay for the direct and qualitative detection of Respiratory Syncytial Virus (RSV) antigen in nasopharyngeal washes, nasopharyngeal aspirates, nasopharyngeal swabs and nasopharyngeal swab/washes from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of Respiratory Syncytial Virus (RSV) infections in neonatal and pediatric patients under the age of 20. It is recommended that negative test results be confirmed by cell culture.
Product codes (comma separated list FDA assigned to the subject device)
GQG
Device Description
The Directigen EZ RSV antigen detection test is a chromatographic assay to detect RSV antigens extracted from various specimens of symptomatic patients. The speed and workflow of the Directigen EZ RSV test make it applicable as a "STAT" RSV antigen detection test, providing rapid, relevant information to assist with antiviral intervention and other clinical or support decisions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal
Indicated Patient Age Range
neonatal and pediatric patients under the age of 20
Intended User / Care Setting
Not Found
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 Hazard Analysis did not identify any changes that raised new issues of safety and effectiveness. The parameters listed below were evaluated in studies performed according to appropriate Design Control procedures. The modified BD Directigen™ EZ RSV assay met all current product claims for performance.
Dry swabs controls must be comparable in stability to current liquid controls: Data to date from accelerated stability studies have indicated 30 months at 2-30C. Confirmatory real time stabilities have indicated 5 months at 2-30C. Real time stabilities will continue.
Dry swabs controls must perform in the assay comparable to the current liquid controls: Dry swabs perform comparably in the assay to the current liquid controls.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
BD Directigen™ EZ RSV assay (K022133)
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.
Not Found
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
§ 866.3480 Respiratory syncytial virus serological reagents.
(a)
Identification. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.(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 § 866.9.
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PAGE 1 OF 3
510(K) SUMMARY
| SUBMITTED BY: | BECTON, DICKINSON AND COMPANY
11085 NORTH TORREY PINES ROAD
SUITE 210
LA JOLLA, CA 92037
Tel: (858) 795 7890
Fax: (858) 795 7885 | JUL-9 2010 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| CONTACT NAME: | Gregory P. Payne, RAC, Director
Regulatory Affairs | |
| DATE PREPARED: | May 28, 2010 | |
| DEVICE TRADE NAME: | BD Directigen™ EZ RSV assay | |
| DEVICE COMMON NAME: | Respiratory Syncytial virus serological
reagents | |
| DEVICE CLASSIFICATION: | 21 CFR 866.3480 | |
| PREDICATE DEVICES : | BD Directigen™ EZ RSV assay (K022133) | |
| INTENDED USE : | | |
The Directigen™ EZ RSV test is a rapid chromatographic immunoassay for the direct and qualitative detection of Respiratory Syncytial Virus (RSV) antigen in nasopharyngeal washes, nasopharyngeal aspirates, nasopharyngeal swabs and nasopharyngeal swab/washes from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of Respiratory Syncytial Virus (RSV) infections in neonatal and pediatric patients under the age of 20. It is recommended that negative test results be confirmed by cell culture.
1
DEVICE DESCRIPTION :
The Directigen EZ RSV antigen detection test is a chromatographic assay to detect RSV antigens extracted from various specimens of symptomatic patients. The speed and workflow of the Directigen EZ RSV test make it applicable as a "STAT" RSV antigen detection test, providing rapid, relevant information to assist with antiviral intervention and other clinical or support decisions.
DEVICE COMPARISON:
The modified kit differs from the currently marketed BD Directigen™ EZ RSV kit in the following way:
The controls have been changed from liquid to dry swabs.
SUBSTANTIAL EQUIVALENCE:
The modified device BD Directigen™ EZ RSV is substantially equivalent to the current legally marketed device, BD Directigen™ EZ RSV assay.
Modifications are as follows:
| Modification | Potential Impact of Modification |
|---|---|
| Change of control from Liquid to dry swab. | Dry controls are more stable than liquid controls. Use |
| of dry control swabs allows for optimal inventory | |
| management during viral outbreaks | |
| Additionally, rare customer complaints regarding control | |
| failures have been attributed to improper processing | |
| (protocol not followed, processing agent not added to | |
| liquid control). This possibility is eliminated by | |
| conversion to dry swab controls. | |
| Dry swabs controls are also supplied by most | |
| competitors. | |
| Dry swabs may not perform like liquid controls or be as | |
| stable. Stability and swab performance studies will | |
| define stability and performance characteristics of the | |
| swabs. |
2
Included in the Special 510(k) are the Hazard Analysis and the associated validations and verifications conducted to address individual hazards/risks identified for this modification. The Hazard Analysis did not identify any changes that raised new issues of safety and effectiveness. The parameters listed below were evaluated in studies performed according to appropriate Design Control procedures. The modified BD Directigen™ EZ RSV assay met all current product claims for performance.
| Parameter | Result |
|---|---|
| Dry swabs controls must be | |
| comparable in stability to current | |
| liquid controls | Data to date from accelerated stability |
| studies have indicated 30 months at 2-30*C. | |
| Confirmatory real time stabilities have | |
| indicated 5 months at 2-30*C. Real time | |
| stabilities will continue. | |
| Dry swabs controls must perform in | |
| the assay comparable to the | |
| current liquid controls | Dry swabs perform comparably in the assay |
| to the current liquid controls. |
3
Image /page/3/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, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Becton. Dickinson and Company BD Diagnostics Gregory P. Payne Director, Regulatory Affairs and Quality Systems 11085 North Torrey Pines Road, Suite 210 La Jolla, CA 92037
JUL 0 9 2010
Re: K101514
Trade/Device Name: BD Directigen™ EZ RSV Assay Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory syncytial virus serological reagents Regulatory Class: Class I Product Code: GQG Dated: May 28, 2010 Received: June 2, 2010
Dear Mr. Payne:
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.
Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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
4
(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.
Jals uAtaym
Sally A. Hoivat, Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Snecial 510(k) Control Swat
Confidential
INDICATION FOR USE
510(K) Number (if known)
Device Name: BD Directigen™ EZ RSV assay
Indication for Use:
The Directigen™ EZ RSV test is a rapid chromatographic immunoassay for the direct and qualitative detection of Respiratory Syncytial Virus (RSV) antigen in nasopharyngeal washes, nasopharyngeal aspirates, nasopharyngeal swabs and nasopharyngeal swab/washes from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of Respiratory Syncytial Virus (RSV) infections in neonatal and pediatric patients under the age of 20. It is recommended that negative test results be confirmed by cell culture.
Prescription Use X 21 CFR 801 Subpart D) And/or
Over the Counter Use (21 CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Uwe Schaf
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 101514