LogoFDA 510(k) Search
K Number
K053570
Device Name
TREP-SURE TREPONEMAL ANTIBODY EIA
Manufacturer
PHOENIX BIOTECH CORP.
Date Cleared
2006-08-07

(228 days)

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

TREP-SURE EIA is a qualitative enzyme immunoassay for the in vitro diagnostic detection of Treponema pallidum (syphilis) antibodies in human serum or plasma. This product can be used as an initial screening test or as a confirmatory diagnostic test, but is not cleared (approved) by the U.S. Food and Drug Administration (FDA) for use in screening blood or plasma donors.

Device Description

Not Found

AI/ML Overview

The provided regulatory document discusses the “Trep-Sure EIA Test” for the detection of Treponema pallidum (syphilis) antibodies. However, the document does not contain the detailed study information, acceptance criteria, or performance metrics typically found in a clinical study report or a more comprehensive FDA submission.

Specifically, the document lacks the following information required to answer the prompt thoroughly:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample size used for the test set and the data provenance.
  3. Number of experts used to establish the ground truth for the test set and their qualifications.
  4. Adjudication method for the test set.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size.
  6. If a standalone (algorithm only) performance study was done.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.
  8. The sample size for the training set.
  9. How the ground truth for the training set was established.

The document is a 510(k) clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device. It briefly mentions the "Indications for Use" but does not provide the technical details of the performance study that led to this clearance.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and study details based on the provided text.

§ 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).