510(k) · Cleared
Recalled · Class II · 2021Captia Measles Igm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trinity Biotech USA · PCL Enzyme Linked Immunoabsorbent Assay, Rubeola Igm
Cleared on May 22, 2014 as substantially equivalent to K904083 (Gull Laboratories, Inc., 1991) after an 87-day review. Its family tree reaches back 1 generation to 1991. It has been recalled 2 times.
- Decided
- May 22, 2014
- Review
- 87 days
- Class
- Class I
- Product code
- PCL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904083 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK904083 Rubeola Igm Elisa TestGull Laboratories, Inc. · 1991
- This deviceK140455 Captia Measles IgmTrinity Biotech USA · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904083 | Rubeola Igm Elisa Test | Gull Laboratories, Inc. | 1991 | — |
| 0 (this device) | K140455 | Captia Measles Igm | Trinity Biotech USA | 2014 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PCL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K904083 | Rubeola Igm Elisa TestSummary page 3…10. Package Insert J. Substantial Equivalence Information: 1. Predicate device name(s): Gull Rubeola IgM ELISA kit 2. Predicate 510(k) number(s): K904083 3. Comparison with predicate: Similarities Item… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2021 | Class II | Z-1503-2021 | Under Investigation by firm | 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 | Nonconforming Material/Component | 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). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All PCL devicesPCL Enzyme Linked Immunoabsorbent Assay, Rubeola Igm: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PCL
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · PCL
Too few PCL 510(k)s in any year since 2007 to give a median.
Recalls per year · PCL
No recall names PCL since 2007.
Adverse event reports per year · PCL
1in 2021
MAUDE reports naming product code PCL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140455: Captia Measles Igm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140455
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026