Cleared Traditional

K874541 - RRT TOTAL IGE TEST KIT

K874541 is an FDA 510(k) clearance for RRT TOTAL IGE TEST KIT, manufactured by Incstar Corp.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K874541 · Incstar Corp. · Immunology device
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Feb 1988
Decision
106d
Days
Class 2
Risk

K874541 is an FDA 510(k) clearance for the RRT TOTAL IGE TEST KIT. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on February 17, 1988 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 - K874541

510(k) Number K874541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1987
Decision Date February 17, 1988
Days to Decision 106 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
1d slower than avg
Panel avg: 105d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGC Device Classification - Class 2, Special Controls

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DGC Ige, Antigen, Antiserum, Control

All 90
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K874541.
PHARMACIA IGE RIA ULTRA
K882625 · Pharmacia, Inc. · Aug 1988
PHARMACIA IGE EIA ULTRA
K882626 · Pharmacia, Inc. · Aug 1988
PHARMACIA IGE RIACT
K881892 · Pharmacia, Inc. · Jun 1988
IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064
K874406 · Medix Biotech, Inc. · Nov 1987
ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5
K872913 · Diagnostic Products Corp. · Sep 1987
UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE
K864142 · United Biotech, Inc. · Dec 1986