Cleared Traditional

K850589 - SPQ TEST SYSTEM FOR TRANSFERRIN

K850589 is an FDA 510(k) clearance for SPQ TEST SYSTEM FOR TRANSFERRIN, manufactured by Applications Lab. The device is a Class 2 Immunology device with product code DDG cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K850589 · Applications Lab · Immunology device
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Mar 1985
Decision
20d
Days
Class 2
Risk

K850589 is an FDA 510(k) clearance for the SPQ TEST SYSTEM FOR TRANSFERRIN. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Applications Lab (Scarborough, US). The FDA issued a Cleared decision on March 5, 1985 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5880 - 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 Applications Lab devices

FDA 510(k) Submission Details - K850589

510(k) Number K850589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1985
Decision Date March 05, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 105d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDG Device Classification - Class 2, Special Controls

Product Code DDG Transferrin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5880
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 - DDG Transferrin, Antigen, Antiserum, Control

All 45
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K850589.
PRECIMAT(R) TRANSFERRIN
K871022 · Boehringer Mannheim Corp. · May 1987
TDX TRANSFERRIN DIAGNOSTIC KIT
K854416 · Abbott Laboratories · Feb 1986
RADIAL IMMUNODIFFUSION PLATES TRANSFERRIN
K851287 · Cooper Biomedical, Inc. · May 1985
IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN
K812492 · Dako Corp. · Sep 1981
72 DETERMIN. SIZE RADIAL IMMUNOD. TEST
K811613 · Kent Laboratories, Inc. · Aug 1981
J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS
K801434 · J.T. Baker Chemical Co. · Jul 1980