Cleared Traditional

K875163 - GOLDENROD ALLERGEN DISC

K875163 is an FDA 510(k) clearance for GOLDENROD ALLERGEN DISC, manufactured by Incstar Corp.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K875163 · Incstar Corp. · Immunology device
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Apr 1988
Decision
127d
Days
Class 2
Risk

K875163 is an FDA 510(k) clearance for the GOLDENROD ALLERGEN DISC. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 127 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Incstar Corp. devices

FDA 510(k) Submission Details - K875163

510(k) Number K875163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1987
Decision Date April 21, 1988
Days to Decision 127 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 105d · This submission: 127d
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 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K875163.
WALNUT ALLERGEN DISC
K874883 · Incstar Corp. · May 1988
INCSTAR'S BIRCH ALLERGEN DISC
K880168 · Incstar Corp. · May 1988
INCSTAR'S PIGWEED ALLERGEN DISC
K880221 · Incstar Corp. · May 1988
ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM
K875244 · Diagnostic Products Corp. · Apr 1988
DPC'S ALLERGEN-SPECIFIC IGE SYSTEM
K880160 · Diagnostic Products Corp. · Apr 1988
INCSTAR'S DANDELION ALLERGEN DISC
K880187 · Incstar Corp. · Apr 1988