# K182479: NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus

- Pathway: 510(k) (Traditional)
- Applicant: Hycor Biomedical
- Decided: Dec 4, 2018 after 85 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: 2 generations back to K962274 (1996). 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)
- K051218: Modification to:  Unicap Specific Ige, Pharmacia Diagnostics AB (2005) Summary page 4.

## Indications for use
NOVEOS™ Immunoassay Analyzer The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for measurement of analyte concentration in human specimens. It is intended for in vitro diagnostic use in the clinical laboratory. NOVEOS™ Specific IgE (sIgE) Assay The NOVEOS™ Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS™ Specific IgE Assay is to be used with the NOVEOS™ Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.

Source page: https://510kreport.com/device/K182479
Methodology: https://510kreport.com/methodology