# K963868: Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Feb 10, 1997 after 137 days
- Product code: DEW (Igg, Antigen, Antiserum, Control)
- 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
Longest line of descent: 1 generation back to K771603 (1977). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771603: Immochemistry System, Beckman Instruments, Inc. (1977) Summary page 1.

## Cited in the summary but kept off the family tree
- K771803: Aca Phosphorus Calibrator, E.I. Dupont DE Nemours & Co., Inc. (1977). Our OCR of the scanned summary read K771803, FDA’s number for Aca Phosphorus Calibrator (E.I. Dupont DE Nemours & Co., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Immunoglobulin G Reagent”. Kept off the family tree. Summary page 1.
- K771608: A-Gent Triglycerides, Abbott Laboratories (1977). Our OCR of the scanned summary read K771608, FDA’s number for A-Gent Triglycerides (Abbott Laboratories). Its FDA name has none of the distinctive words the summary uses for the device it names, “Immunoglobulin A Reagent”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K993549: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc) Reagent, Beckman Coulter Cerebr (2000), 3 descendants of its own
- K993547: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin M (Igmlc) Reagent, Beckman Coulter Cereb (2000), 2 descendants of its own
- K183151: Optilite IgA CSF Kit (2019), 0 descendants of its own
- K130122: Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin, Beckman Coulter (2014), 0 descendants of its own
- K060130: Immage Systems Low Concentration Immunoglobulin a Reagent (2006), 0 descendants of its own

## Recalls of this device
- Jul 31, 2024 · Class II · Z-0118-2025: Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU
- Jun 6, 2003 · Not classified · Z-1150-04: low level IgM serum sample results may be suppressed and an error code generated when using affected lots. Error codes are seen as E60 or E66.

## Indications for use
The IMMAGE Immunochemistry System Immunoglobulin G (IGG) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin G by rate nephelometry. The IMMAGE immunochemistry System immunoglobulin A (IGA) reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin A by rate nephelometry. The IMMAGE immunochemistry System Immunoglobulin M (IGM) reagent, when used in conjunction with Beckman IMMAGE™ immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of human immunoglobulin M by rate nephelometry.

Source page: https://510kreport.com/device/K963868
Methodology: https://510kreport.com/methodology