# K020823: Peliclass Human Igg Subclass Nephelometric Immage Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sanquin Blood Supply Foundation
- Decided: May 14, 2002 after 61 days
- Product code: DFZ (Igg (Gamma Chain Specific), Antigen, Antiserum, Control)
- 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: 1 generation back to K982023 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982023: Pelicalss Human Igg Subclass Nephlometric Array Kit, Inova Diagnostics, Inc. (1998) Summary page 1.

## Indications for use
The contents of the Peliclass™ Human IgG Subclass Nephelometric IMMAGE® Kit will allow quantitative determination of all four IgG Subclasses in at least 50 serum samples with the Beckman IMMAGE Immunochemistry System. The determination of IgG subclasses is to be used in conjunction with other clinical findings to aid in the assessment of the humoral immune status.

Source page: https://510kreport.com/device/K020823
Methodology: https://510kreport.com/methodology