Cleared Traditional

K885307 - FLIPSCREEN (TM) TOTAL E IMMUNOASSAY

K885307 is the FDA 510(k) clearance for FLIPSCREEN (TM) TOTAL E IMMUNOASSAY by Alerchek, Inc.. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K885307 · Alerchek, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
71d
Days
Class 2
Risk

K885307 is an FDA 510(k) clearance for the FLIPSCREEN (TM) TOTAL E IMMUNOASSAY. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Alerchek, Inc. (Portland, US). The FDA issued a Cleared decision on March 8, 1989 after a review of 71 days - a notably fast clearance cycle.

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: 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 Alerchek, Inc. devices

Submission Details

510(k) Number K885307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1988
Decision Date March 08, 1989
Days to Decision 71 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 104d · This submission: 71d
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 84
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K885307.
PHARMACIA CAP SYSTEM IGE RIA AND FEIA
K893951 · Pharmacia, Inc. · Jul 1989
ALATOP (TM) CATALOG # AKAL1
K892197 · Diagnostic Products Corp. · Jun 1989
N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS)
K890530 · Behring Diagnostics, Inc. · Mar 1989
DELFIA (TM) HIGE KIT
K884545 · Pharmacia, Inc. · Nov 1988
PHARMACIA IGE RIA ULTRA
K882625 · Pharmacia, Inc. · Aug 1988
PHARMACIA IGE EIA ULTRA
K882626 · Pharmacia, Inc. · Aug 1988