Cleared Traditional

K870095 - BILIRUBIN TESTER (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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
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.