Cleared Traditional

K981588 - CARESIDE TOTAL BILIRUBIN

K981588 is the FDA 510(k) clearance for CARESIDE TOTAL BILIRUBIN by Careside, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K981588 · Careside, Inc. · Chemistry device
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Jun 1998
Decision
50d
Days
Class 2
Risk

K981588 is an FDA 510(k) clearance for the CARESIDE TOTAL BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on June 23, 1998 after a review of 50 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 Careside, Inc. devices

Submission Details

510(k) Number K981588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1998
Decision Date June 23, 1998
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
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 169
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K981588.
TBIL
K983133 · Abbott Laboratories · Sep 1998
DBIL
K981943 · Abbott Laboratories · Jul 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844
K981883 · Boehringer Mannheim Corp. · Jul 1998
BILIRUBIN-SL (DIRECT) ASSAY CATALOGUE NUMBER 247-10,247-30
K981609 · Diagnostic Chemicals , Ltd. · Jun 1998
TBIL
K981336 · Abbott Laboratories · May 1998
DIRECT BILIRUBIN (DBIL)
K981222 · Abbott Laboratories · Apr 1998