# K082129: Human Igm Liquid Reagent Kit for Use on the Spaplus Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Feb 10, 2009 after 196 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K191635: Optilite IgM Kit (2019), 1 descendant of its own
- K250159: Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser (2025), 0 descendants of its own
- K191465: Human IgM Kit for use on SPAPlus (2019), 0 descendants of its own

## Recalls of this device
- Nov 6, 2018 · Class II · Z-0604-2019: Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.
- Jul 25, 2018 · Class II · Z-0477-2019: After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after r

## Indications for use
This kit is intended for the quantitative in vitro determination of human IgM in human serum, heparinised or EDTA plasma, using the Binding Site SPApLusTM turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.

Source page: https://510kreport.com/device/K082129
Methodology: https://510kreport.com/methodology