510(k) · Cleared
Recalled · Class II · 2016Randox Ige
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories, Ltd. · DGC Ige, Antigen, Antiserum, Control
Cleared on May 15, 2001 after a 54-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled once.
- Decided
- May 15, 2001
- Review
- 54 days
- Class
- Class II
- Product code
- DGC
- Recalls
- 1
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DGC? 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 DGC device
- #1 K231151 Kenota 1 Total IgE; Kenota 1 (instrument)score 8.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|---|
| Sep 7, 2016 | Class II | Z-0050-2017 | Under Investigation by firm | According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DGC devicesDGC Ige, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DGC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DGC
Too few DGC 510(k)s in any year since 2007 to give a median.
Recalls per year · DGC
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DGC
2in 2021
MAUDE reports naming product code DGC, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 5 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 1 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K010855 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010855: Randox Ige.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010855
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026