Hycor Biomedical · Class II · Cleared Dec 23, 2025
| K-number | K252493 |
| Device name | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica) |
| Applicant | Hycor Biomedical |
| Product code | DHB |
| Device class | Class II |
| Decision date | Dec 23, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 866.5750 |
The NOVEOS Specific IgE Assay is an in vitro quantitative immunoassay that measures allergen-specific IgE antibodies in human serum to aid in clinical diagnosis of IgE-mediated allergic disorders. It is used with the NOVEOS Immunoassay Analyzer in clinical laboratory settings and evaluates four specific allergens: Shrimp (F024), Clam (F207), Walnut (F256), and German Cockroach (I006).
The NOVEOS uses fluorescence-adjusted chemiluminescent detection with magnetic microparticles and a horseradish peroxidase conjugate, compared to the predicate ImmunoCAP which uses a β-galactosidase enzyme and cellulose solid phase. Both employ heterologous calibration traceable to WHO reference reagent IgE 11/234, six calibrator levels, and stored calibration curves up to 28 days. NOVEOS requires only 4 µL sample volume versus ImmunoCAP's 40 µL, and shares identical assay ranges and reaction temperature (37°C).
CLSI guideline EP05-A3 (precision evaluation), CLSI EP15-A3 (user verification of precision), CLSI EP06-2nd Edition (linearity evaluation), CLSI EP07 (interference testing), CLSI EP17-A2 (detection capability), CLSI EP28-A3c (reference intervals), CLSI EP25-Ed2 (stability evaluation), and CLSI I/LA20-3rd Edition (immunological assay performance characteristics).
NOVEOS is substantially equivalent to the predicate ImmunoCAP (K051218) because both are automated immunoassays measuring specific allergen IgE in serum for the same clinical indication and intended use in clinical laboratories. Despite differences in detection chemistry and solid phase, both share identical assay principles, calibration methodology, assay ranges, and clinical performance. The device demonstrates acceptable clinical sensitivity (35–93% depending on allergen), 100% specificity, acceptable precision and linearity, and appropriate detection limits comparable to the predicate.
View the full FDA submission: accessdata.fda.gov