Cleared Traditional

K801434 - J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS

K801434 is the FDA 510(k) clearance for J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS by J.T. Baker Chemical Co.. It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K801434 · J.T. Baker Chemical Co. · Immunology device
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Jul 1980
Decision
20d
Days
Class 2
Risk

K801434 is an FDA 510(k) clearance for the J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on July 8, 1980 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 J.T. Baker Chemical Co. devices

Submission Details

510(k) Number K801434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1980
Decision Date July 08, 1980
Days to Decision 20 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
84d faster than avg
Panel avg: 104d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (DDG) and FDA review panel - the closest regulatory comparables to K801434.
TDX TRANSFERRIN DIAGNOSTIC KIT
K854416 · Abbott Laboratories · Feb 1986
IMMUNOGL. FRCT. OF RABBIT ANTISER.-TRAN
K812492 · Dako Corp. · Sep 1981
72 DETERMIN. SIZE RADIAL IMMUNOD. TEST
K811613 · Kent Laboratories, Inc. · Aug 1981
TRANSFERRIN NEPHELOMETRIC ASSAY
K772253 · Kallestad Laboratories, Inc. · Dec 1977