(82 days)
Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. The test is intended as an aid in the diagnosis of syphilis infection in conjunction with clinical signs and symptoms.
The Elecsys Syphilis immunoasay is not in screening blood or tissue donors. The effectiveness of this assay in testing blood or tissue donors has not been established.
The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.
The Elecsys Syphilis immunoassay is a fully automated, qualitative assay that uses a double antigen sandwich format for the detection of IgM and IgG antibodies to T. pallidum.
Recombinant T. pallidum antigens labeled with either biotin or a ruthenium complex bind to T. pallidum-specific IgG or IgM to form a double antigen sandwich complex. The sandwich complex binds to streptavidin-coated microparticles which can be immobilized magnetically to the surface of an electrode. Unbound substances are removed during a wash step using ProCell. A chemiluminescent substrate is then added to the reaction tube. Application of a voltage to the electrode induces a chemiluminescent emission which is measured by a photomultiplier.
The presence or absence of anti-TP antibodies in the specimen is determined by comparing the chemiluminescent signal in the reaction to the cutoff index (COI) determined from an active calibration. The strength of the signal generated is proportional to the amount of bound conjugate and thus the amount of anti-T. pallidum antibodies present in the specimen. If the chemiluminescent signal in the reaction is greater than or equal to the cutoff signal, the specimen is considered reactive for anti-TP antibodies. If the chemiluminescent signal is below the cutoff signal, the specimen is considered nonreactive for the anti-TP antibodies.
The provided text describes the Elecsys Syphilis immunoassay, an in vitro diagnostic device, and its evaluation for substantial equivalence to a predicate device (Elecsys Syphilis K160910) following an update to improve biotin tolerance.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission revolve around demonstrating that the updated Elecsys Syphilis assay is as safe and effective as the predicate device, with the added benefit of improved biotin tolerance. The document states that "All performance specifications were met." While specific numerical acceptance criteria for each study (e.g., precision coefficients of variation, acceptable bias for method comparison) are not explicitly detailed as a formal table with pass/fail values, the reported device performance indicates that these criteria were satisfied.
| Study Type | Acceptance Criteria (Implied/General) | Reported Device Performance |
|---|---|---|
| Precision (CLSI EP5-A3) | Demonstrate acceptable repeatability and intermediate imprecision for controls and human serum samples. | Repeatability (CV%): |
| HS, negative 1: 1.5; HS, negative 2: 2.0; HS, positive 1: 1.6; HS, positive 2: 2.4; HS, positive 3: 2.9; HS, positive 4: 2.5; HS, positive 5: 2.4; PC Syphilis 1: 1.1; PC Syphilis 2: 2.1 | ||
| Intermediate Precision (CV%): | ||
| HS, negative 1: 1.7; HS, negative 2: 3.0; HS, positive 1: 2.4; HS, positive 2: 3.1; HS, positive 3: 3.6; HS, positive 4: 3.6; HS, positive 5: 3.3; PC Syphilis 1: 1.4; PC Syphilis 2: 2.6 | ||
| (These values are generally considered excellent for immunoassays, implying they met the internal acceptance limits.) | ||
| Biotin Interference (CLSI EP07-A3) | No significant interference with analyte quantitation up to a specified biotin concentration. | Maximum value with no interference observed was 2400 ng/mL. The claim in the Instruction for Use will be ** |
§ 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).