Cleared Special

K081217 - HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM

K081217 is an FDA 510(k) clearance for HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM, manufactured by Hycor Biomedical, Inc.. The device is a Class 2 Immunology device with product code DHB cleared through the Special 510(k) pathway after a 22-day FDA review.

K081217 · Hycor Biomedical, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
22d
Days
Class 2
Risk

K081217 is an FDA 510(k) clearance for the HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on May 22, 2008 after a review of 22 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 Hycor Biomedical, Inc. devices

FDA 510(k) Submission Details - K081217

510(k) Number K081217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2008
Decision Date May 22, 2008
Days to Decision 22 days
Submission Type Special
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
83d faster than avg
Panel avg: 105d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K081217.
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