Cleared Traditional

K875110 - HOUSE DUST

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

K875110 is an FDA 510(k) clearance for HOUSE DUST, 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 183-day FDA review.

K875110 · Incstar Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K875110

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 105d · This submission: 183d
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 K875110.
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM)
K883616 · Diagnostic Products Corp. · Sep 1988
DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)
K883273 · 3M Company · Sep 1988
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.
K881899 · Diagnostic Products Corp. · Aug 1988
PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA
K880899 · Pharmacia, Inc. · May 1988
MARSH ELDER ALLERGEN DISC
K874540 · Incstar Corp. · May 1988
WALNUT ALLERGEN DISC
K874883 · Incstar Corp. · May 1988