Cleared Traditional

K010325 - WAKO AUTOKIT C4

K010325 is an FDA 510(k) clearance for WAKO AUTOKIT C4, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Immunology device with product code DBI cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K010325 · Wako Chemicals USA, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
143d
Days
Class 2
Risk

K010325 is an FDA 510(k) clearance for the WAKO AUTOKIT C4. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on June 25, 2001 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K010325

510(k) Number K010325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2001
Decision Date June 25, 2001
Days to Decision 143 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
38d slower than avg
Panel avg: 105d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBI Device Classification - Class 2, Special Controls

Product Code DBI Complement C4, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DBI Complement C4, Antigen, Antiserum, Control

All 27
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K010325.
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
K012359 · Roche Diagnostics Corp. · Nov 2001
RANDOX COMPLEMENT C4
K000468 · Randox Laboratories, Ltd. · Mar 2000
DIMENSION C4 FLEX REAGENT CARTRIDGE
K994293 · Dade Behring, Inc. · Mar 2000
C4 MININEPH ANTISERUM
K981785 · The Binding Site, Ltd. · Dec 1999
K-ASSAY C4
K993481 · Kamiya Biomedical Co. · Nov 1999
C4
K983356 · Abbott Laboratories · Nov 1998