Cleared Traditional

K891240 - DIRECT BILIRUBIN FOR CONTINUOUS FLOW

K891240 is the FDA 510(k) clearance for DIRECT BILIRUBIN FOR CONTINUOUS FLOW by Catachem, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K891240 · Catachem, Inc. · Chemistry device
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May 1989
Decision
64d
Days
Class 2
Risk

K891240 is an FDA 510(k) clearance for the DIRECT BILIRUBIN FOR CONTINUOUS FLOW. 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 May 10, 1989 after a review of 64 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 K891240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1989
Decision Date May 10, 1989
Days to Decision 64 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
24d faster than avg
Panel avg: 88d · This submission: 64d
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 K891240.
DIRECT BILIRUBIN REAGENT
K893730 · Medical Analysis Systems, Inc. · Aug 1989
TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS
K892668 · Catachem, Inc. · Jul 1989
DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.
K892905 · Catachem, Inc. · Jun 1989
TOTAL BILIRUBIN FOR CONTINUOUS FLOW
K891025 · Catachem, Inc. · Apr 1989
TOTAL BILIRUBIN REAGENT, CONCENTRATED
K890070 · Trace Scientific , Ltd. · Mar 1989
TOTAL BILIRUBIN TEST CATALOG NO. SR1007
K885284 · Em Diagnostic Systems, Inc. · Jan 1989