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K Number
K971502
Device Name
SERODIA TP-PA
Manufacturer
SCIMEDX TEKFILE SERVICES
Date Cleared
1997-11-13

(203 days)

Product Code
GMT
Regulation Number
866.3830
Type
Traditional
Panel
MI
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

Particle Agglutination Test

AI/ML Overview

The provided text is a 510(k) clearance letter for the Serodia TP-PA Syphilis Particle Agglutination Test. It states that the device is substantially equivalent to a legally marketed predicate device but does not contain any information about acceptance criteria or specific studies performed to prove device performance.

The letter is primarily focused on regulatory approval and classification, not on the detailed technical specifications or performance data of the device.

Therefore, I cannot provide the requested information based on the given input. The document does not describe:

  • A table of acceptance criteria or reported device performance.
  • Sample sizes for test sets or data provenance.
  • Number or qualifications of experts for ground truth.
  • Adjudication methods.
  • MRMC comparative effectiveness studies or effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • Sample size or establishment of ground truth for training sets.

§ 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).