Cleared Traditional

K874163 - ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS

K874163 is an FDA 510(k) clearance for ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTR..., manufactured by Catachem, Inc.. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K874163 · Catachem, Inc. · Chemistry device
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Nov 1987
Decision
41d
Days
Class 2
Risk

K874163 is an FDA 510(k) clearance for the ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Catachem, Inc. (Port Chester, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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

FDA 510(k) Submission Details - K874163

510(k) Number K874163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date November 23, 1987
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIX Device Classification - Class 2, Special Controls

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CIX Bromcresol Green Dye-binding, Albumin

All 106
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K874163.
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