Cleared Traditional

K870095 - BILIRUBIN TESTER

K870095 is an FDA 510(k) clearance for BILIRUBIN TESTER, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K870095

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.

CIG Device Classification - Class 2, Special Controls

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 215
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
BILIRUBIN TOTAL
K863056 · J. D. Assoc. · Nov 1986