(20 days)
Not Found
No
The device description and performance studies focus on immunochromatographic assay technology and do not mention any AI or ML components.
No.
This device is an in vitro diagnostic test designed to detect Legionella antigen in urine, aiding in the diagnosis of Legionnaires' Disease, rather than providing therapy or treatment.
Yes
The device is described as aiding "in the presumptive diagnosis of Legionella infection" by detecting specific antigens in urine.
No
The device description clearly outlines a physical immunochromatographic assay with a test strip, swab well, and reagent, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro rapid immunochromatographic assay for the qualitative detection of Legionella serogroup 1 antigen... in urine specimens." The term "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device analyzes "urine specimens from patients," which are biological samples taken from the human body.
- Purpose: The purpose is to "aid in the presumptive diagnosis of Legionella infection," which is a diagnostic purpose.
- Device Description: The description details a laboratory test using antibodies and a membrane assay to detect an antigen in a biological sample.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of a potential recipient with a potential donor, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Binax NOW® Legionella Urinary Antigen Test is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection ("Legionnaires" Disease) caused by L. pneumophila serogroup 1 in conjunction with culture and other methods.
Product codes
MJH
Device Description
The Binax NOW® Legionella Urinary Antigen Test is an immunochromatographic membrane assay to detect Legionella pneumophila serogroup 1 antigen in human urine. A test strip, containing gold-conjugated and immobilized anti-Legionella pneumophila serogroup 1 antibodies, and a swab well are mounted on opposite sides of a cardboard, book-shaped hinged test device. A Dacron swab is dipped into the urine to be tested and then inserted into the swab well. A single reagent is added to the swab well from a dropper bottle before closing Legionella urinary antigen captured by immobilized anti-Legionella the test device. pneumophila antibody reacts to bind anti-Legionella pneumophila conjugated antibody, forming the Sample Line. Immobilized control antibody captures anti-species conjugate, forming the Control Line. There are no transferring steps, the sample is contained, and results are available in 15 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary (urine specimens)
Indicated Patient Age Range
Not Found
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)
Stability, Method Comparison, Cross Reactivity and Loss of Signal testing were performed on the modified device to ensure its equivalence to the unmodified device. The changes to the NOW® Legionella Urinary Antigen Test have not affected its safety or effectiveness as detailed below:
STABILITY STUDIES:
Stability studies of the modified test are currently ongoing,
METHOD COMPARISON:
Seventy (70) urine samples, collected from presumed healthy individuals, were tested on the modified and cleared devices yielding negative results and demonstrating 100% agreement between the two devices. Fifteen (15) known positive urine specimens were tested on the modified and unmodified devices yielding positive results and again demonstrating 100% agreement.
CROSS-REACTIVITY TESTING:
In the original 510(K) submission, cross reactivity testing was performed using urines from patients diagnosed with other (non-Legionella) bacterial or fungal pneumonia or urinary tract infections. In lieu of this, whole organism cross-reactivity testing was performed to compare the modified and unmodified devices.
Given that modifications to the device do NOT impact the detection portion of the assay, a limited cross-reactant panel of 11 organisms was tested. The panel included organisms associated with pneumonia as well as those likely to be found in the urogenital tract as normal flora or as the result of a urinary tract infection. None of the organisms, grown in culture and tested at clinically relevant concentrations (depending on the organism 1 x 10° to 2 x 103), tested positive on the modified test.
LOSS OF SIGNAL (LOS) TESTING:
Serial two-fold dilutions of a known positive urine specimen were run on the unmodified and modified devices. Three (3) separate lots of the modified device were tested against unmodified devices. In all three studies, the same dilution of the positive urine provided loss of signal on both the unmodified and modified devices.
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
§ 866.3300
Haemophilus spp. serological reagents.(a)
Identification. Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identifyHaemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusHaemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused byHaemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
510(k) Summary
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
SUBMITTER
Binax, Inc. d/b/a Inverness Medical Professional Diagnostics 10 Southgate Road Scarborough, Maine 04074
MAR 1 5 2007
CONTACT PERSON
Karen Mortimer (207) 730-5705 (Office) (207) 730-5710 (Fax) Karen.mortimer@invmed.com
ALTERNATE CONTACT
Pamela Angell (207) 730-5738 (Office) (207) 730-5710 (Fax) Pam.angell@invmed.com
DATE PREPARED
February 13, 2007
TRADE NAME
Binax NOW® Legionella Urinary Antigen Test
COMMON NAME
Legionella ICT
CLASSIFICATION NAME
Haemophilus spp. Serological reagents (per 21 CFR 866.3300)
PREDICATE DEVICE
Binax NOW® Legionella Urinary Antigen Test (unmodified) 510 (k) number K982238
DEVICE DESCRIPTION
The Binax NOW® Legionella Urinary Antigen Test is an immunochromatographic membrane assay to detect Legionella pneumophila serogroup 1 antigen in human urine. A test strip, containing gold-conjugated and immobilized anti-Legionella pneumophila serogroup 1 antibodies, and a swab well are mounted on opposite sides of a cardboard, book-shaped hinged test device. A Dacron swab is dipped into the urine to be tested and then inserted into the swab well. A single reagent is added to the swab well from a dropper bottle before closing Legionella urinary antigen captured by immobilized anti-Legionella the test device. pneumophila antibody reacts to bind anti-Legionella pneumophila conjugated antibody, forming the Sample Line. Immobilized control antibody captures anti-species conjugate, forming the Control Line. There are no transferring steps, the sample is contained, and results are available in 15 minutes.
1
nary (contir
INTENDED USE
The Binax NOW® Legionella Urinary Antigen Test is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection ("Legionnaires" Disease) caused by L. pneumophila serogroup 1 in conjunction with culture and other methods.
TECHNOLOGICAL CHARACTERISTICS
The Binax NOW® Legionella Urinary Antigen Test uses lateral flow immunochromatographic technology. The test is a rapid immunoassay that employs specific antibodies immobilized onto a solid phase to capture and visualize Legionella pneumophila serogroup 1 antigen. (The modified and cleared Binax NOW® Legionella Urinary Antigen Tests share the same technological characteristics and antigen detection reagents. Assay procedure, intended use and product claims are unchanged for the modified device.)
PERFORMANCE SUMMARY
Stability, Method Comparison, Cross Reactivity and Loss of Signal testing were performed on the modified device to ensure its equivalence to the unmodified device. The changes to the NOW® Legionella Urinary Antigen Test have not affected its safety or effectiveness as detailed below:
STABILITY STUDIES:
Stability studies of the modified test are currently ongoing,
METHOD COMPARISON:
Seventy (70) urine samples, collected from presumed healthy individuals, were tested on the modified and cleared devices yielding negative results and demonstrating 100% agreement between the two devices. Fifteen (15) known positive urine specimens were tested on the modified and unmodified devices yielding positive results and again demonstrating 100% agreement.
CROSS-REACTIVITY TESTING:
In the original 510(K) submission, cross reactivity testing was performed using urines from patients diagnosed with other (non-Legionella) bacterial or fungal pneumonia or urinary tract infections. In lieu of this, whole organism cross-reactivity testing was performed to compare the modified and unmodified devices.
Given that modifications to the device do NOT impact the detection portion of the assay, a limited cross-reactant panel of 11 organisms was tested. The panel included organisms associated with pneumonia as well as those likely to be found in the urogenital tract as normal flora or as the result of a urinary tract infection. None of the organisms, grown in culture and tested at clinically relevant concentrations (depending on the organism 1 x 10° to 2 x 103), tested positive on the modified test.
LOSS OF SIGNAL (LOS) TESTING:
Serial two-fold dilutions of a known positive urine specimen were run on the unmodified and modified devices. Three (3) separate lots of the modified device were tested against
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510 (k) Summary (continued) 11:40:00
- 05
unmodified devices. In all three studies, the same dilution of the positive urine provided loss of signal on both the unmodified and modified devices.
lifell and amo 2116/07 ______________________________________________________________________________________________________________________________________________________________________________ Signed
Pamela Angell, Director, Worldwide Clinical Affairs Binax, Inc. d/b/a Inverness Medical Professional Diagnostics
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Karen Mortimer Clinical Affairs Specialist Binax, Inc. Inverness Medical Professional Diagnostics 10 Southgate Road Scarborough, ME 04074
MAR 1 5 2007
Re: K070522
Trade/Device Name: BinaxNOW® Legionella Urinary Antigen Test Regulation Number: 21 CFR 866.3300 Regulation Name: Haemophilus spp. serological reagents Regulatory Class: Class II Product Code: MJH Dated: February 14, 2007 Received: February 23, 2007
Dear Ms. Mortimer:
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)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Sally, attorn
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 STATEMENT
510(k) Number (if known): _ Kn 705 32
Device Name: BinaxNOw® Legionella Urinary Antigen Test
Indications For Use:
The Binax NOW® Legionella Urinary Antigen Test is an in vitro rapid immunochromatographic assay for the qualitative detection of Legionella serogroup 1 antigen (L. pneumophila serogroup 1 antigen) in urine specimens from patients with symptoms of pneumonia. It is intended to aid in the presumptive diagnosis of Legionella infection (Legionnaires' disease) caused by L. pneumophila serogroup 1 in conjunction with culture and other methods.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
Freddie Lu-Poole
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
070522