Cleared Traditional

K970986 - WAKO DIRECT BILIRUBIN V

K970986 is the FDA 510(k) clearance for WAKO DIRECT BILIRUBIN V by Wako Chemicals USA, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K970986 · Wako Chemicals USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
50d
Days
Class 2
Risk

K970986 is an FDA 510(k) clearance for the WAKO DIRECT BILIRUBIN V. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on May 7, 1997 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - the FDA in vitro diagnostics and chemistry 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 K970986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1997
Decision Date May 07, 1997
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
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 faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 Chemistry devices follow this clearance model.

Regulatory Peers - CIG Diazo Colorimetry, Bilirubin

All 168
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K970986.
BILIRUBIN-SL (TOTAL) ASSAY
K974874 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1998
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
K973109 · Synermed, Inc. · Sep 1997
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K972716 · Synermed, Inc. · Aug 1997
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K963939 · Synermed, Inc. · Dec 1996
DIRECT BILIRUBIN (DND) ASSAY, CATALOGUE NUMBER 209-05
K955880 · Diagnostic Chemicals , Ltd. · Aug 1996
TOTAL BILIRUBIN PROCEDURE
K955300 · Data Medical Associates, Inc. · Dec 1995