Cleared Traditional

HOUSE DUST (K875110) - FDA 510(k) Clearance

Also marketed or referenced as:
HOLLISTER-STIER (H/S) ALLERGEN DISC

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K875110 · Incstar Corp. · Immunology device
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Jun 1988
Decision
183d
Days
Class 2
Risk

K875110 is an FDA 510(k) clearance for the HOUSE DUST. 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 June 14, 1988 after a review of 183 days - an extended review 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: 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

Submission Details

510(k) Number K875110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1987
Decision Date June 14, 1988
Days to Decision 183 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 104d · This submission: 183d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 264
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