Cleared Traditional

K892905 - DIRECT BILIRUBIN FOR MANUAL OR AUTOMATE...

K892905 is the FDA 510(k) clearance for DIRECT BILIRUBIN FOR MANUAL OR AUTOMATE... by Catachem, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K892905 · Catachem, Inc. · Chemistry device
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Jun 1989
Decision
60d
Days
Class 2
Risk

K892905 is an FDA 510(k) clearance for the DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on June 19, 1989 after a review of 60 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 Catachem, Inc. devices

Submission Details

510(k) Number K892905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1989
Decision Date June 19, 1989
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
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 K892905.
CLINISTAT TOTAL BILIRUBIN REAGENT TEST
K892801 · Heraeus Kulzer, Inc. · Aug 1989
DIRECT BILIRUBIN REAGENT
K893730 · Medical Analysis Systems, Inc. · Aug 1989
TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS
K892668 · Catachem, Inc. · Jul 1989
DIRECT BILIRUBIN FOR CONTINUOUS FLOW
K891240 · Catachem, Inc. · May 1989
TOTAL BILIRUBIN FOR CONTINUOUS FLOW
K891025 · Catachem, Inc. · Apr 1989
TOTAL BILIRUBIN REAGENT, CONCENTRATED
K890070 · Trace Scientific , Ltd. · Mar 1989