Cleared Traditional

K860027 - FLIPSCREEN SPECIFIC E (PE

K860027 is the FDA 510(k) clearance for FLIPSCREEN SPECIFIC E (PE by Alerchek, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K860027 · Alerchek, Inc. · Immunology device
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Apr 1986
Decision
109d
Days
Class 2
Risk

K860027 is an FDA 510(k) clearance for the FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Alerchek, Inc. (Portland, US). The FDA issued a Cleared decision on April 22, 1986 after a review of 109 days - within the typical 510(k) review window.

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 Alerchek, Inc. devices

Submission Details

510(k) Number K860027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1986
Decision Date April 22, 1986
Days to Decision 109 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 104d · This submission: 109d
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 200
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K860027.
VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY
K862901 · Ventrex Laboratories, Inc. · Sep 1986
PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS
K861184 · Pharmacia, Inc. · Apr 1986
PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5
K854865 · Pharmacia, Inc. · Apr 1986
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K854939 · Pharmacia, Inc. · Feb 1986
PHADEBAS RAST TEST ALLERGEN DISCS
K853969 · Pharmacia, Inc. · Nov 1985
VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY
K850895 · Ventrex Laboratories, Inc. · Oct 1985