Cleared Traditional

K854416 - TDX TRANSFERRIN DIAGNOSTIC KIT

K854416 is an FDA 510(k) clearance for TDX TRANSFERRIN DIAGNOSTIC KIT, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code DDG cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K854416 · Abbott Laboratories · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
109d
Days
Class 2
Risk

K854416 is an FDA 510(k) clearance for the TDX TRANSFERRIN DIAGNOSTIC KIT. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on February 21, 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 866.5880 - 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: 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K854416

510(k) Number K854416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1985
Decision Date February 21, 1986
Days to Decision 109 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
5d slower than avg
Panel avg: 104d · This submission: 109d
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 40
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K854416.
QM300 TRANSFERRIN ANTIBODY PACK
K873789 · Kallestad Diag, A Div. of Erbamont, Inc. · Oct 1987
TINA-QUANT [A] TRANSFERRIN
K871896 · Boehringer Mannheim Corp. · Jun 1987
PRECIMAT(R) TRANSFERRIN
K871022 · Boehringer Mannheim Corp. · May 1987
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