Cleared Traditional

K890070 - TOTAL BILIRUBIN REAGENT

K890070 is the FDA 510(k) clearance for TOTAL BILIRUBIN REAGENT by Trace Scientific , Ltd.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K890070 · Trace Scientific , Ltd. · Chemistry device
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Mar 1989
Decision
56d
Days
Class 2
Risk

K890070 is an FDA 510(k) clearance for the TOTAL BILIRUBIN REAGENT, CONCENTRATED. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on March 6, 1989 after a review of 56 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 Trace Scientific , Ltd. devices

Submission Details

510(k) Number K890070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1989
Decision Date March 06, 1989
Days to Decision 56 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
32d faster than avg
Panel avg: 88d · This submission: 56d
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 K890070.
DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.
K892905 · Catachem, Inc. · Jun 1989
DIRECT BILIRUBIN FOR CONTINUOUS FLOW
K891240 · Catachem, Inc. · May 1989
TOTAL BILIRUBIN FOR CONTINUOUS FLOW
K891025 · Catachem, Inc. · Apr 1989
TOTAL BILIRUBIN TEST CATALOG NO. SR1007
K885284 · Em Diagnostic Systems, Inc. · Jan 1989
DIRECT BILIRUBIN TEST CATALOG NO. SR1008
K885285 · Em Diagnostic Systems, Inc. · Jan 1989
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM
K880437 · Abbott Laboratories · Aug 1988