(393 days)
The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires' disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only.
The SAS™ Legionella test utilizes a combination of polyclonal antibodies against the antigens of Legionella pneumophila. The SAS™ Legionella test begins with the addition of urine to the test device. The specimen is absorbed by the sample pad and then moves through the conjugate pad which contains dried gold conjugated antibodies which are specific for Legionella pneumophila antigens; if the Legionella antigens are present in the urine sample, a "half-sandwich" immunocomplex is formed. This immuno-complex then migrates via capillary action along a nitrocellulose membrane containing immobilized antibodies to Legionella pneumophila antigens. The immobilized antibodies bind the "half-sandwich" immuno-complex to form a "whole sandwich" immuno-complex. Thus, when the "whole sandwich" is formed, a visible, pink colored line develops in the specimen zone on the test device. In the absence of a Legionella antigen, a "sandwich" immuno-complex is not formed and a negative result is indicated. To serve as a procedural control, a pink colored control line will always appear in the control zone regardless of the presence or absence of Legionella antigen. The test is available in cassette format.
{
"1_table_of_acceptance_criteria_and_reported_device_performance": {
"Acceptance Criteria (Implicit)": "To demonstrate substantial equivalence to the predicate device (Binax™ Now® Legionella Urinary Antigen Test) and to culture methods for the detection of Legionella pneumophila serogroup 1 antigens in human urine.",
"Reported Device Performance": "The SAS™ Legionella Test performed substantially equivalent to the predicate device, Binax™ Now® Legionella Urinary Antigen Test and to culture. Cross reactivity and interference studies showed no interference or cross-reaction with common viral and bacterial strains found in human urine."
},
"2_sample_size_used_for_the_test_set_and_data_provenance": {
"Sample Size (Test Set)": "Not explicitly stated. The document mentions \"frozen and fresh urine specimens\" were used for comparison but does not provide a specific number.",
"Data Provenance": "Not explicitly stated (e.g., country of origin). The data is retrospective based on the use of \"frozen and fresh urine specimens\" for comparison."
},
"3_number_of_experts_used_to_establish_the_ground_truth_for_the_test_set_and_qualifications": "Not applicable. The ground truth was established by comparison to a predicate device (Binax™ Now® Legionella Urinary Antigen Test) and culture methods, not by expert interpretation of the device results.",
"4_adjudication_method_for_the_test_set": "Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on image interpretation, which is not relevant for this immunochromatographic rapid assay.",
"5_if_a_multi_reader_multi_case_mrmc_comparative_effectiveness_study_was_done": "No. This is an immunochromatographic rapid assay, not an imaging device requiring human reader interpretation in a MRMC study.",
"6_if_a_standalone_performance_study_was_done": "Yes. The performance of the SAS™ Legionella Test (algorithm only, as it's a diagnostic kit) was directly compared against established methods (predicate device and culture) for diagnostic accuracy.",
"7_the_type_of_ground_truth_used": "Comparison to a legally marketed predicate device (Binax™ Now® Legionella Urinary Antigen Test) and culture methods. Culture is generally considered a gold standard for bacterial identification.",
"8_the_sample_size_for_the_training_set": "Not applicable. As a diagnostic test kit, there isn't a 'training set' in the machine learning sense. The device is developed through biochemical assays and optimizations, not by training an algorithm on a 'training set' of data.",
"9_how_the_ground_truth_for_the_training_set_was_established": "Not applicable. See #8. The development of such a test relies on established scientific principles of immunology and antigen-antibody reactions, and validation against known Legionella-positive and -negative samples, rather than a 'ground truth' established for a training set in machine learning."
}
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SAS™ Legionella Test
JUN 2 8 2007
The 510(k) summary of safety and effectiveness submission is in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Submitted by: | SA Scientific, Ltd.4919 Golden QuailSan Antonio, TX 78240 |
|---|---|
| Establishment Reg. No. | 1645225 |
| Contact Person: | Veronica DeLeon |
| Date Prepared: | May 30, 2006 |
| Proprietary Name: | SAS™ Legionella Test |
| Common Name: | SAS™ Legionella Test, SAS™ Legionella pneumophilaTest |
| Classification Name: | Legionella, SPP., Elisa |
| Device Classification: | 21 CFR 866.3300 |
| Regulatory Class: | Class II |
| Product Code: | MJH |
| Substantial Equivalence: | Binax™ Now® Legionella Urinary Antigen Testmanufactured by Binax™ Inc., Portland, Maine |
| Device Description: | The SAS™ Legionella test utilizes a combination ofpolyclonal antibodies against the antigens of Legionellapneumophila. The SAS™ Legionella test begins withthe addition of urine to the test device. The specimen isabsorbed by the sample pad and then moves throughthe conjugate pad which contains dried gold conjugatedantibodies which are specific for Legionellapneumophila antigens; if the Legionella antigens arepresent in the urine sample, a "half-sandwich"immunocomplex is formed. This immuno-complex thenmigrates via capillary action along a nitrocellulosemembrane containing immobilized antibodies toLegionella pneumophila antigens. The immobilizedantibodies bind the "half-sandwich" immuno-complex to |
:
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form a "whole sandwich" immuno-complex. Thus, when the "whole sandwich" is formed, a visible, pink colored line develops in the specimen zone on the test device. In the absence of a Legionella antigen, a "sandwich" immuno-complex is not formed and a negative result is indicated. To serve as a procedural control, a pink colored control line will always appear in the control zone regardless of the presence or absence of Legionella antigen. The test is available in cassette format.
Intended Use: The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires' disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only.
Quality Controls: The SAS™ Legionella Test provides two (2) internal procedural controls. It is recommended that external quality controls should be performed on each new test kit box opened. Positive and negative external controls are supplied separately.
Device Comparison: The SAS™ Legionella Test and Binax™ Now® Legionella Urinary Antigen Test are rapid immunoassays tests utilizing immunochromatographic technology for the visualization of Legionella pneumophila antigen. Each utilizes an antibody conjugated to colored particles and an antibody printed onto a membrane.
Performance Summary: The SAS™ Legionella Test performed substantially equivalent to the predicate device, Binax™ Now® Legionella Urinary Antigen Test and to culture. This was verified by comparison of frozen and fresh urine specimens.
Cross reactivity and interference studies were performed on viral and bacterial strains commonly found in human urine. None of the organisms interfered or cross-reacted with the performance of the SAS™ Legionella Test.
ii
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Prepared by: Veronica De Leon
Regulatory Affairs
Date: 6/21/07
:
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Image /page/3/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services (USA). The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the perimeter of the logo. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person embracing another person.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 8 2007
Veronica DeLeon Regulatory Affairs SA Scientific, Ltd. 4919 Golden Quail San Antonio, TX 78240
Re: K061496
Trade/Device Name: SAS™ Legionella Test Regulation Number: 21CFR 866. 3300 Regulation Name: Haemophilus spp. Serological Reagents Regulatory Class: Class II Product Code: MJH Dated: May 30, 2006 Received: May 31, 2006
Dear Ms. DeLeon:
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
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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 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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Sallanz
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
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INDICATIONS FOR USE
Applicant: SA Scientific, Inc. 4919 Golden Quail San Antonio, TX. 78240 Ph: (210) 699-8800 Fax: (210) 699-6545
Establishment Reg. No .: 1645225
501(k) Number: 06 / 496
Device Names:
SAS™ Legionella Test
Indications for Use:
The SAS™ Legionella Test is a visually read, in vitro immunochromatographic rapid assay for the presumptive qualitative detection of Legionella pneumophila serogroup 1 antigens in human urine. This test is intended to aid in the presumptive diagnosis of Legionnaires' disease in conjunction with culture and other methods for patients with signs and symptoms of pneumonia. This test is for prescription use only.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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) allou Division Sign-Off
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Office of In Vitro Dlagnostic Device Evaluation and Safety Page 1 of __ |
510(k) k o l y q l
§ 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.