510(k) · Cleared
ClearedIncstar Cytomegalovirus Igm Capture Elisa Assay Model 8530
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incstar Corp. · LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Cleared on Oct 17, 1996 as substantially equivalent to K896295 (Mercia Diagnostics, Ltd., 1990) after a 260-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Oct 17, 1996
- Review
- 260 days
- Class
- Class II
- Product code
- LFZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896295 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK896295 Captia (R) CMV-MMercia Diagnostics, Ltd. · 1990
- This deviceK960434 Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530Incstar Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896295 | Captia (R) CMV-M | Mercia Diagnostics, Ltd. | 1990 | — |
| 0 (this device) | K960434 | Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530 | Incstar Corp. | 1996 | — |
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 LFZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LFZ device
- #1 K220911 Elecsys CMV IgGscore 4.8 · 3 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K896295 | Captia (R) CMV-MSummary page 2…VENESS (continued) SAFETY AND EFFECTIVENESS: The INCSTAR CMV IgM Capture ELISA Kit is substantially equivalent (SE) to the BioWhittaker CMV CAP-M ELISA test, 510(k) No K896295, which has been cleared by the FDA and is currently in U.S. commercial distribution. In clinical performance studies, 529 serum… | 1990 |
| † | K503807 | Gull CMV IgM ELISA |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LFZ devicesLFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFZ
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LFZ
Too few LFZ 510(k)s in any year since 2007 to give a median.
Recalls per year · LFZ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFZ
53in 2025
MAUDE reports naming product code LFZ, 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 | 7 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 1 | 14 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 2 | — | 0 | 13 |
| 2018 | 1 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 2 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 34 |
| 2025 | 0 | — | 1 | 53 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The INCSTAR CMV IgM Capture ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgM antibodies to cytomegalovirus in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active CMV infection. The evaluation of paired CMV IgM sera can also aid in determining the stage of active CMV infection.
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/K960434 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960434: Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960434
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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