Cleared Traditional

K191510 - Noveos Immunoanalyzer System

K191510 is an FDA 510(k) clearance for Noveos Immunoanalyzer System, manufactured by Hycor Biomedical. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K191510 · Hycor Biomedical · Immunology device
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Jul 2019
Decision
55d
Days
Class 2
Risk

K191510 is an FDA 510(k) clearance for the Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D00.... Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Hycor Biomedical (Garden Grove, US). The FDA issued a Cleared decision on July 31, 2019 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hycor Biomedical devices

FDA 510(k) Submission Details - K191510

510(k) Number K191510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2019
Decision Date July 31, 2019
Days to Decision 55 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 104d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DHB System, Test, Radioallergosorbent (rast) Immunological

All 214
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K191510.
Allergen-Specific IgE Assay 12 Allergen Bundle
K193613 · Hitachi Chemical Diagnostics, Inc. · Oct 2021
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus
K200825 · Hycor Biomedical · Jun 2020
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine
K200279 · Phadia AB · May 2020
ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat
K190315 · Phadia AB · May 2019
AP3600 Automated Instrument
K182793 · Hitachi Chemical Diagnostics, Inc. · Mar 2019
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
K182479 · Hycor Biomedical · Dec 2018