Capture-CMV

K183571 · Immucor, Inc. · LJO · Feb 4, 2019 · Microbiology

Device Facts

• Record ID: K183571
• Device Name: Capture-CMV
• Applicant: Immucor, Inc.
• Product Code: LJO · Microbiology
• Decision Date: Feb 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3175
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV is intended to be used in screening of blood and plasma donors or patients for serological evidence of previous infection by CMV.

Device Story

Capture-CMV is a solid-phase red cell adherence test system for qualitative detection of IgG and IgM antibodies to CMV. Input: human serum or plasma added to viral-coated microtitration wells. Principle: CMV-specific antibodies bind to immobilized viral proteins; unbound immunoglobulins washed away; anti-IgG/IgM-coated indicator red cells added. Centrifugation forces indicator cells into contact with bound antibodies. Positive result: indicator cells adhere to well surface (migration impeded by antibody bridges). Negative result: indicator cells pellet to bottom. Used in clinical/donor screening settings; operated by laboratory personnel. Output: visual or automated interpretation of cell adherence vs. pelleting. Assists clinicians in identifying seropositive donors/patients to reduce CMV transmission risk in immunocompromised populations (e.g., neonates, transplant/oncology patients).

Clinical Evidence

Method comparison study (N=501) comparing NEO Iris to Galileo Neo. Sensitivity 100.0% (95% LCI 98.7%); Specificity 97.8% (95% LCI 95.0%). Discordant results resolved via particle agglutination assay. Reproducibility study (N=1200 tests) across three sites showed 100% positive concordance and 99.8% negative concordance.

Technological Characteristics

Solid-phase red cell adherence assay. Components: microtitration wells coated with inactivated CMV strain AS 169; anti-IgG/IgM-coated indicator red cells; Capture LISS buffer. Energy source: centrifugation. Connectivity: automated on NEO Iris analyzer. Software: automated interpretation of adherence patterns.

Indications for Use

Indicated for screening blood/plasma donors or patients for serological evidence of previous CMV infection. Applicable to human serum or plasma samples.

Regulatory Classification

Identification

Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: K183571

This 510(k) was reviewed under OIR’s Triage-Quick Review 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.