Cleared Traditional

K874540 - MARSH ELDER ALLERGEN DISC

K874540 is the FDA 510(k) clearance for MARSH ELDER ALLERGEN DISC by Incstar Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K874540 · Incstar Corp. · Immunology device

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May 1988

Decision

190d

Days

Class 2

Risk

K874540 is an FDA 510(k) clearance for the MARSH ELDER 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 May 11, 1988 after a review of 190 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	K874540 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 03, 1987
Decision Date	May 11, 1988
Days to Decision	190 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

86d slower than avg

Panel avg: 104d · This submission: 190d

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 K874540.

SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.

K881899 · Diagnostic Products Corp. · Aug 1988

HOUSE DUST

K875110 · Incstar Corp. · Jun 1988

PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA

K880899 · Pharmacia, Inc. · May 1988

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

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K874540

Incstar Corp.

Stillwater, MN · US

JOHN G YAGER

Regulatory profile

58 submissions 57 cleared

98% clearance rate · Active in Immunology

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Sourced from FDA 510(k) public files . Updated monthly.

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