# K140455: Captia Measles Igm

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech USA
- Decided: May 22, 2014 after 87 days
- Product code: PCL (Enzyme Linked Immunoabsorbent Assay, Rubeola Igm)
- Device class: 1
- Regulation: 21 CFR 866.3520
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904083 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904083: Rubeola Igm Elisa Test, Gull Laboratories, Inc. (1991) Summary page 3.

## Recalls of this device
- Mar 17, 2021 · Class II · Z-1503-2021: Positive Control may run high out of its assigned ISR range and result in an invalid run and necessitate retesting
- Jul 11, 2016 · Class III · Z-2782-2016: The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).

## Indications for use
The Trinity Biotech Captia™ Measles IgM Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative detection of Measles IgM antibodies in human serum of patients suspected of measles (rubeola) infection. This assay is intended for use as an aid in the diagnosis of a current or recent measles (rubeola) infection in conjunction with other clinical information and laboratory findings. Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use in neonatal screening or for use at a point of care. This test is not intended for use in screening blood and plasma donors.

Source page: https://510kreport.com/device/K140455
Methodology: https://510kreport.com/methodology