Cleared Traditional

K843178 - TOTAL BILIRUBIN TEST

K843178 is the FDA 510(k) clearance for TOTAL BILIRUBIN TEST by Sclavo, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K843178 · Sclavo, Inc. · Chemistry device

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Sep 1984

Decision

25d

Days

Class 2

Risk

K843178 is an FDA 510(k) clearance for the TOTAL BILIRUBIN TEST. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Sclavo, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 7, 1984 after a review of 25 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 Sclavo, Inc. devices

Submission Details

510(k) Number	K843178 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 13, 1984
Decision Date	September 07, 1984
Days to Decision	25 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

63d faster than avg

Panel avg: 88d · This submission: 25d

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 K843178.

DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE

K850901 · Data Medical Associates, Inc. · Apr 1985

SYSTEMATE T-BILI 67212

K843328 · Em Diagnostic Systems, Inc. · Sep 1984

SYSTEMATE D-BILI 67213

K843329 · Em Diagnostic Systems, 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

ACA CONJUGATED BILIRUBIN ANALYTICAL

K842385 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1984

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K843178

Sclavo, Inc.

Mchenry, IL · US

Regulatory profile

82 submissions 82 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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