510(k) · Cleared
ClearedAccurun 146 CMV Igm Positive Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Biomedica, Inc. · LKQ Antibody Igm,If, Cytomegalovirus Virus
Cleared on Aug 22, 1997 after a 17-day review. The FDA summary names no predicate by number.
- Decided
- Aug 22, 1997
- Review
- 17 days
- Class
- Class II
- Product code
- LKQ
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 LKQ? 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?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LKQ devicesLKQ Antibody Igm,If, Cytomegalovirus Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKQ
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LKQ
Too few LKQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LKQ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKQ
17in 2022
MAUDE reports naming product code LKQ, 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 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 2 | 29 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 68 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
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/K972884 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972884: Accurun 146 CMV Igm Positive Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972884
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026