Cleared Traditional

K870095 - BILIRUBIN TESTER

K870095 is the FDA 510(k) clearance for BILIRUBIN TESTER by Wako Chemicals USA, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K870095 · Wako Chemicals USA, Inc. · Chemistry device
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Jun 1987
Decision
145d
Days
Class 2
Risk

K870095 is an FDA 510(k) clearance for the BILIRUBIN TESTER. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on June 3, 1987 after a review of 145 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K870095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1987
Decision Date June 03, 1987
Days to Decision 145 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 88d · This submission: 145d
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 K870095.
TOTAL BILIRUBIN REAGENT - DMSO METHOD
K870364 · Trace Scientific , Ltd. · Aug 1987
DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD
K870365 · Trace Scientific , Ltd. · Aug 1987
PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT
K872197 · Sigma Diagnostics, Inc. · Aug 1987
REAGENTS 1263,1273,1284,1425,014301,053583
K871531 · American Research Products Co. · May 1987
TOTAL BILIRUBIN REAGENT 1372,1425,1284,1273,053583
K871530 · American Research Products Co. · May 1987
DIRECT BILIRUBIN PROCEDURE
K863265 · Data Medical Associates, Inc. · Oct 1986