Cleared Traditional

K832357 - ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK

K832357 is the FDA 510(k) clearance for ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK 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 45-day FDA review.

K832357 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry device
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Sep 1983
Decision
45d
Days
Class 2
Risk

K832357 is an FDA 510(k) clearance for the ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK. 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 September 1, 1983 after a review of 45 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 K832357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1983
Decision Date September 01, 1983
Days to Decision 45 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
43d faster than avg
Panel avg: 88d · This submission: 45d
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 K832357.
LIQUI ZYME TOTAL BILIRUBIN REAGENT
K840564 · American Research Products Co. · Mar 1984
PARAMAX TOTAL BILIRUBIN REAGENT
K833004 · American Dade · Oct 1983
DIAZO COLORIMETRY, BILLIRUBIN
K832870 · Pointe Scientific, Inc., · Sep 1983
SIGMA PROCEDURE #550 DETERM. BILIRUB
K832236 · Sigma Chemical Co. · Aug 1983
GILCHEM TOTAL BILIRUBIN REAGENT
K831843 · Gilford Diagnostics · Jul 1983
DIRECT BILIRUBIN REAGENT
K831844 · Gilford Diagnostics · Jul 1983