# K130122: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 7, 2014 after 355 days
- Product code: CFN (Method, Nephelometric, Immunoglobulins (G, A, M))
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K771603 (1977). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993547: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc) Reagent, Beckman Coulter Cereb, Beckman Coulter, Inc. (2000) Summary page 4.
- (no number) Beckman Coulter Cerebrospinal Fluid Protein Calibrator (CSF CAL): named in the summary without a submission number

## Indications for use
IMMAGE Immunochemistry Systems IGMLC Reagent when used in conjunction with IMMAGE Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of Immunoglobulin M (IGMLC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry. CSF Cal (Cerebrospinal Fluid Protein Calibrator), when used in conjunction with Beckman Coulter Low Concentration Immunoglobulin A (IGALC) and Low Concentration Immunoglobulin M (IGMLC) reagents is intended for use on Immage for the calibration of these reagents.

Source page: https://510kreport.com/device/K130122
Methodology: https://510kreport.com/methodology