Cleared Traditional

LIQUI ZYME TOTAL BILIRUBIN REAGENT (K840564) - FDA 510(k) Clearance

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

K840564 · American Research Products Co. · Chemistry device
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Mar 1984
Decision
30d
Days
Class 2
Risk

K840564 is an FDA 510(k) clearance for the LIQUI ZYME TOTAL BILIRUBIN REAGENT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by American Research Products Co. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1984 after a review of 30 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 American Research Products Co. devices

Submission Details

510(k) Number K840564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1984
Decision Date March 09, 1984
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
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 K840564.
ACA CONJUGATED BILIRUBIN ANALYTICAL
K842385 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984
EKTACHEM CLINICAL CHEM. SLIDES
K840880 · Eastman Kodak Company · Apr 1984
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