# K220949: Architect CMV IgG

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 27, 2022 after 209 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920661 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181213: ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control, Siemens Healthcare Diagnostics, Inc. (2018) Summary page 5.
- K920661: Vidas CMV Igg Assay, Vitek Systems, Inc. (1993) Summary page 19.

## Indications for use
The ARCHITECT CMV IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibodies to cytomegalovirus in human serum, serum separator, and plasma tubes (lithium heparin, lithium heparin separator, and tripotassium EDTA) on the ARCHITECT i System. The ARCHITECT CMV IgG assay is to be used as an aid in the diagnosis of infection with cytomegalovirus and as an aid in the determination of serological status to cytomegalovirus in individuals including women of child-bearing age. The ARCHITECT CMV IgG assay has not been cleared for use in screening blood, plasma, or tissue donors. The ARCHITECT CMV IgG Calibrators are for the calibration of the ARCHITECT i System when used for the qualitative detection of IgG antibodies to cytomegalovirus in human serum and plasma. The ARCHITECT CMV IgG Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the qualitative detection of IgG antibodies to cytomegalovirus in human serum and plasma.

Source page: https://510kreport.com/device/K220949
Methodology: https://510kreport.com/methodology