Cleared Traditional

K993162 - WAKO TRANSFERRIN

K993162 is the FDA 510(k) clearance for WAKO TRANSFERRIN by Wako Chemicals USA, Inc.. It is a Class 2 Immunology device (product code DDG) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K993162 · Wako Chemicals USA, Inc. · Immunology device
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Nov 1999
Decision
51d
Days
Class 2
Risk

K993162 is an FDA 510(k) clearance for the WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR. Classified as Transferrin, Antigen, Antiserum, Control (product code DDG), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on November 12, 1999 after a review of 51 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K993162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1999
Decision Date November 12, 1999
Days to Decision 51 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 104d · This submission: 51d
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 K993162.
RANDOX TRANSFERRIN
K002585 · Randox Laboratories, Ltd. · Feb 2001
DIMENSION TRNF FLEX REAGENT CARTRIDGE
K994294 · Dade Behring, Inc. · Feb 2000
K-ASSAY TRANSFERRIN
K993537 · Kamiya Biomedical Co. · Nov 1999
N LATEX STFR REAGENT
K991157 · Dade Behring, Inc. · Aug 1999
TRANSFERRIN SPQ III ANTIBODY REAGENT SET
K983880 · DiaSorin, Inc. · Dec 1998
TRF
K983167 · Abbott Laboratories · Nov 1998