# K993547: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc) Reagent, Beckman Coulter Cereb

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Feb 1, 2000 after 105 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K771603 (1977). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963868: Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm), Beckman Instruments, Inc. (1997) Summary page 1.
- K823884: Paragon Immunoelectrophoresis Reagent, Beckman Instruments, Inc. (1983) Summary page 1.

## Most influential descendants
- K130122: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter (2014), 0 descendants of its own
- K032014: N Latex Igm (2003), 0 descendants of its own

## Recalls of this device
- Jun 6, 2003 · Not classified · Z-1146-04: Inconsistent results are obtained depending upon the matrix or sample source (plasma versus cerebrospinal fluid).

## Indications for use
The IMMAGE® Immunochemistry System Low Concentration Immunoglobulin M (IGMLC) Reagent, when used in conjunction with Beckman Coulter's IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for the quantitative determination of human immunoglobulin M in serum and cerebrospinal fluid by rate nephelometry.

Source page: https://510kreport.com/device/K993547
Methodology: https://510kreport.com/methodology