ELECSYS HSV-2 IGG IMMUNOASSAY

K121895 · Roche Diagnostics · JJX · Aug 24, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121895
• Device Name: ELECSYS HSV-2 IGG IMMUNOASSAY
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Roche Elecsys HSV-2 IgG immunoassay is a test for the in vitro qualitative determination of IgG class antibodies to HSV-2 in human serum and lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended for sexually active individuals and expectant mothers as an aid in presumptive diagnosis of HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the indicated Elecsys and cobas e immunoassay analyzers. This test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities. The Elecsys PreciControl HSV is used for quality control of the Elecsys HSV-2 IgG immunoassay on the Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys HSV-2 IgG is a two-step sandwich immunoassay using streptavidin microparticles and biotinylated recombinant HSV-2-specific antigen labeled with a ruthenium complex. Device utilizes electrochemiluminescence (ECLIA) detection on Elecsys and cobas e immunoassay analyzers. Input is human serum or plasma (lithium-heparin, K2-EDTA, K3-EDTA). System performs automated calculation of cut-off index (COI) based on two-point calibration using negative and positive calibrators. Output is qualitative (reactive/non-reactive) based on COI >= 1.0. Used in clinical laboratories by trained personnel. Results aid physicians in presumptive diagnosis of HSV-2 infection when correlated with clinical history and symptoms. Benefits include automated, standardized testing compared to manual methods.

Clinical Evidence

Clinical performance evaluated across three cohorts: expectant mothers (n=125), sexually active individuals (n=469), and low prevalence population (n=200). Positive percent agreement ranged from 75.00% to 97.83%; negative percent agreement ranged from 98.47% to 98.73%. Agreement with CDC panel was 100%. Analytical specificity tested against 13 cross-reactants with 100% agreement.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence detection. Reagents: streptavidin-coated microparticles, biotinylated recombinant HSV-2 antigen (E. coli), ruthenylated HSV-2 antigen. Automated platform (Elecsys/cobas e series). Calibration: two-point, lot-specific. Controls: lyophilized human serum-based. Connectivity: integrated with analyzer software.

Indications for Use

Indicated for sexually active individuals and expectant mothers as an aid in presumptive diagnosis of HSV-2 infection. Not for pediatric, neonatal, immunocompromised patients, or point-of-care use. Not for blood/plasma donor screening.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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Statement for the Record, K121895

510(k) Holder: Roche Diagnostics
Device Name: Elecsys HSV-2 IgG Immunoassay

This 510(k) was reviewed under OIVD's Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant's 510(k) summary for a summary of the information that supports this SE determination.