# K972884: Accurun 146 CMV Igm Positive Control

- Pathway: 510(k) (Traditional)
- Applicant: Boston Biomedica, Inc.
- Decided: Aug 22, 1997 after 17 days
- Product code: LKQ (Antibody Igm,If, Cytomegalovirus Virus)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Boston Biomedica intends to manufacture and market ACCURUN™ 146 CMV IgM Positive Control, which is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Cytomegalovirus (CMV). This control is not intended as a substitute for controls provided with test kits. This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgM antibodies to CMV in human serum and plasma.

Source page: https://510kreport.com/device/K972884
Methodology: https://510kreport.com/methodology