510(k) · Cleared
ClearedHuman Igg Subclass Liquid Reagent Kits, Product Code LK001.T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site, Ltd. · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Cleared on Aug 31, 2001 after a 42-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 31, 2001
- Review
- 42 days
- Class
- Class II
- Product code
- CFN
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFN? 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 CFN device
- #1 K233663 N Antisera to Human Immunoglobulins (IgG, IgA…score 8.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 CFN devicesCFN Method, Nephelometric, Immunoglobulins (G, A, M): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFN
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CFN
28in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CFN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFN
1in 2024
MAUDE reports naming product code CFN, 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 | 7 | 69 | 0 | 0 |
| 2009 | 4 | 160 | 0 | 0 |
| 2010 | 2 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 4 | 431 | 0 | 0 |
| 2014 | 2 | — | 5 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 2 | 2 |
| 2019 | 6 | 28 | 0 | 8 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 1 |
| 2023 | 2 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This kit is intended for quantifying IgG subclasses 1, 2, 3 and 4 immunoglobulins in serum on the BNII. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012296 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012296: Human Igg Subclass Liquid Reagent Kits, Product Code LK001.T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012296
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026