Cleared Traditional

K873486 - RED TOP ALLERGEN DISC

K873486 is the FDA 510(k) clearance for RED TOP ALLERGEN DISC by Incstar Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K873486 · Incstar Corp. · Immunology device
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Oct 1987
Decision
37d
Days
Class 2
Risk

K873486 is an FDA 510(k) clearance for the RED TOP 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 October 7, 1987 after a review of 37 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Incstar Corp. devices

Submission Details

510(k) Number K873486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date October 07, 1987
Days to Decision 37 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
67d faster than avg
Panel avg: 104d · This submission: 37d
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 199
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K873486.
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K873193 · Pharmacia, Inc. · Oct 1987
BAHIA ALLERGEN DISC
K873648 · Incstar Corp. · Oct 1987
MODIFIED PHADEBAS RAST/PHADEZYM RAST
K872280 · Pharmacia, Inc. · Oct 1987
IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT
K873676 · Incstar Corp. · Oct 1987
RRT SHORT RAGWEED TEST KIT
K873406 · Incstar Corp. · Sep 1987
ALTERNARIA TENUIS ALLERGEN DISC
K871684 · Incstar Corp. · Jul 1987