Cleared Traditional

K842385 - ACA CONJUGATED BILIRUBIN ANALYTICAL

K842385 is the FDA 510(k) clearance for ACA CONJUGATED BILIRUBIN ANALYTICAL by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K842385 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry device
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Aug 1984
Decision
60d
Days
Class 2
Risk

K842385 is an FDA 510(k) clearance for the ACA CONJUGATED BILIRUBIN ANALYTICAL. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 60 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K842385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1984
Decision Date August 17, 1984
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
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 171
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K842385.
TOTAL BILIRUBIN TEST
K843178 · Sclavo, Inc. · Sep 1984
BILIRUBIN ASSAY KIT DIRECT
K843027 · Diagnostic Chemicals, Ltd. (Usa) · Sep 1984
BILIRUBIN ASSAY KIT - TOTAL
K843032 · Diagnostic Chemicals, Ltd. (Usa) · Sep 1984
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN
K842809 · Technicon Instruments Corp. · Aug 1984
RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT
K841892 · Reagents Applications, Inc. · Jun 1984
DIRECT BILIRUBIN REAGENT
K841572 · Hi Chem, Inc. · May 1984