# K982023: Pelicalss Human Igg Subclass Nephlometric Array Kit

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Sep 4, 1998 after 87 days
- Product code: DAS (Igg (Fc Fragment Specific), Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K020823: Peliclass Human Igg Subclass Nephelometric Immage Kit (2002), 0 descendants of its own

## Indications for use
The contents of the Peliclass™ subclass nephelometric Array® kit will allow quantitative determination of all four IgG subclasses in at least 25 samples with the Beckman Array ® Protein 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/K982023
Methodology: https://510kreport.com/methodology