Cleared Special

K030590 - CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) (FDA 510(k) Clearance)

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K030590 · Hitachi Chemical Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
24d
Days
Class 2
Risk

K030590 is an FDA 510(k) clearance for the CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82). Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Hitachi Chemical Diagnostics, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 21, 2003 after a review of 24 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hitachi Chemical Diagnostics, Inc. devices

Submission Details

510(k) Number K030590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2003
Decision Date March 21, 2003
Days to Decision 24 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 104d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 263
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