Cleared Traditional

K874541 - RRT TOTAL IGE TEST KIT

K874541 is the FDA 510(k) clearance for RRT TOTAL IGE TEST KIT by Incstar Corp.. It is a Class 2 Immunology device (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

Submission Details

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
2d slower than avg
Panel avg: 104d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 83
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
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE--
K863858 · Hybritech, Inc. · Nov 1986