Cleared Traditional

DOW BILIRUBIN(DIRECT) DETERMINATION (K820714) - FDA 510(k) Clearance

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

K820714 · The Dow Chemical Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
17d
Days
Class 2
Risk

K820714 is an FDA 510(k) clearance for the DOW BILIRUBIN(DIRECT) DETERMINATION. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by The Dow Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on April 1, 1982 after a review of 17 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 The Dow Chemical Co. devices

Submission Details

510(k) Number K820714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1982
Decision Date April 01, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
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 68
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K820714.
EKTACHEM CLINICAL CHEM. SLIDES
K840606 · Eastman Kodak Company · Apr 1984
ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK
K832357 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1983
SIGMA PROCEDURE #550 DETERM. BILIRUB
K832236 · Sigma Chemical Co. · Aug 1983
BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD
K812784 · Beckman Instruments, Inc. · Oct 1981
BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN
K812754 · Beckman Instruments, Inc. · Oct 1981
BILIRUBIN, DINGLE VALVE DPD
K781921 · Boehringer Mannheim Corp. · Jan 1979