# K964260: Immage Immunochemistry System Kappa Light Chain (Kap) Reagent Immage Immunochemistry System Lamda Light Chain (Lam) Reag

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Feb 10, 1997 after 108 days
- Product code: DFH (Kappa, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884276 (1988). 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)
- K884276: Beckman Kappa Light Chain Reagent, Beckman Instruments, Inc. (1988) Summary page 1.
- K902484: Beckman Kappa Light Chain Reagent (Add'l Claims), Beckman Instruments, Inc. (1990) Summary page 1.
- K884597: Beckman Lambda Light Chain Reagent, Beckman Instruments, Inc. (1988) Summary page 1.

## Most influential descendants
- K083602: Kappa Light Chains (2009), 0 descendants of its own
- K083601: Lambda Light Chains (2009), 0 descendants of its own

## Indications for use
The IMMAGE Immunochemistry System Kappa (KAP) Reagent, when used in conjunction with Beckman IMMAGE ™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of kappa light chains (free and bound) by rate nephelometry. The IMMAGE immunochemistry System Lambda (LAM) Reagent, when used in conjunction with Beckman IMMAGE ™ immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of lambda light chains (free and bound) by rate nephelometry.

Source page: https://510kreport.com/device/K964260
Methodology: https://510kreport.com/methodology