Cleared Traditional

K843027 - BILIRUBIN ASSAY KIT DIRECT

K843027 is the FDA 510(k) clearance for BILIRUBIN ASSAY KIT DIRECT by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K843027 · Diagnostic Chemicals, Ltd. (Usa) · Chemistry device
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Sep 1984
Decision
34d
Days
Class 2
Risk

K843027 is an FDA 510(k) clearance for the BILIRUBIN ASSAY KIT DIRECT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Canada, US). The FDA issued a Cleared decision on September 4, 1984 after a review of 34 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 Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K843027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1984
Decision Date September 04, 1984
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 K843027.
SYSTEMATE T-BILI 67212
K843328 · Em Diagnostic Systems, Inc. · Sep 1984
SYSTEMATE D-BILI 67213
K843329 · Em Diagnostic Systems, Inc. · Sep 1984
TOTAL BILIRUBIN TEST
K843178 · Sclavo, Inc. · Sep 1984
BILIRUBIN ASSAY KIT - TOTAL
K843032 · Diagnostic Chemicals, Ltd. (Usa) · Sep 1984
ACA CONJUGATED BILIRUBIN ANALYTICAL
K842385 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN
K842809 · Technicon Instruments Corp. · Aug 1984