# K973186: Immulite Cat-Specific Ige, Immulite Dog-Specific Ige,Immulite Mite-Specific Ige

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Sep 29, 1997 after 35 days
- Product code: DHB (System, Test, Radioallergosorbent (Rast) Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5750
- 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 K911511 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911511: Alastat Allergen Specified Ige System, Modified, Diagnostic Products Corp. (1991) Summary page 1.
- K954566: Specific Allergen Modules for the Alastat Microplate Allergen-Specific Ige System, Diagnostic Products Corp. (1995) Summary page 1.

## Indications for use
DPC's IMMULITE® Cat/Dog/Mite-Specific IgE kits are clinical use devices intended for use with the IMMULITE Automated Immunoassay Analyzer to measure circulating levels of IgE antibodies specific to Cat Epithelium, Dog Dander and Dematophagoides pteronyssinus in serum. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

Source page: https://510kreport.com/device/K973186
Methodology: https://510kreport.com/methodology