(203 days)
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No
The summary describes a qualitative gelatin particle agglutination assay, which is a traditional laboratory test method and does not mention any AI or ML components.
No
The device is described as a diagnostic assay for detecting antibodies, which aids in diagnosis rather than providing therapy.
Yes
The "Intended Use / Indications for Use" states it is "intended to be used for the detection of Treponema pallidum antibodies... as an aid in the diagnosis of syphilis."
No
The device is described as a "qualitative gelatin particle agglutination assay" and a "Particle Agglutination Test," which are laboratory-based tests involving physical reagents and samples, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "qualitative gelatin particle agglutination assay intended to be used for the detection of Treponema pallidum antibodies in human serum or plasma as an aid in the diagnosis of syphilis." This clearly describes a test performed in vitro (outside the body) on human samples (serum or plasma) to provide information for diagnosis.
- Device Description: While brief, "Particle Agglutination Test" describes a method commonly used in IVD assays.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
Serodia-TP-PA is a qualitative gelatin particle agglutination assay intended to be used for the detection of Treponema pallidum antibodies in human serum or plasma as an aid in the diagnosis of syphilis. This product is not cleared or approved by the U.S. Food and Drug Administration (FDA) for use in screening blood or plasma donors.
Product codes
GMT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).
0
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 3 1997
Gary Lehnus, Ph.D. Scientific and Regulatory Director Scimedx Tekfile, Corp. 400 Ford Road Denville. New Jersey 07834
Re: K971502 Trade Name: Serodia TP-PA Syphilis Regulatory Class: II Product Code: GMT Dated: September 11, 1997 Received: September 12, 1997
Dear Dr. Lehnus:
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 requirement, as set forth in the Quality System Regulation (OS) 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
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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 your 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 vours.
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
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510(k) Number (if known):
Device Name: Serodia TP-PA Syphilis
Particle Agglutination Test
Indications For Use:
Serodia-TP-PA is a qualitative gelatin particle agglutination assay intended to be used for the detection of Treponema pallidum antibodies in human serum or plasma as an aid in the diagnosis of syphilis. This product is not cleared or approved by the U.S. Food and Drug Administration (FDA) for use in screening blood or plasma donors.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean Cooper
(Division Sign-Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K971502
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)