Cleared Traditional

K801300 - DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)

K801300 is the FDA 510(k) clearance for DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Chemistry device (product code JIW) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K801300 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry device
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Jul 1980
Decision
36d
Days
Class 2
Risk

K801300 is an FDA 510(k) clearance for the DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL). Classified as Calibrator, Surrogate (product code JIW), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 8, 1980 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 K801300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1980
Decision Date July 08, 1980
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIW Calibrator, Surrogate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIW Calibrator, Surrogate

All 12
Devices cleared under the same product code (JIW) and FDA review panel - the closest regulatory comparables to K801300.
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200
K880654 · American Research Products Co. · Jun 1988
UNIMETER CALIBRATION KIT
K880610 · Boehringer Mannheim Corp. · Mar 1988
NEPHELOMETRIC SOLID TURBIDITY STANDARD
K812220 · Hyland Therapeutic Div., Travenol Laboratories · Aug 1981
CENTRIFICHEM FILTER CALIBRATION SET
K800304 · Union Carbide Corp. · Mar 1980
CENTRIFICHEM FILTER CALIBRATION SET
K790643 · Union Carbide Corp. · May 1979