Cleared Traditional

K874049 - MULTICHEM ALBUMIN REAGENT S0902

K874049 is the FDA 510(k) clearance for MULTICHEM ALBUMIN REAGENT S0902 by Simmler, Inc.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K874049 · Simmler, Inc. · Chemistry device
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Oct 1987
Decision
24d
Days
Class 2
Risk

K874049 is an FDA 510(k) clearance for the MULTICHEM ALBUMIN REAGENT S0902. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Simmler, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 29, 1987 after a review of 24 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 Simmler, Inc. devices

Submission Details

510(k) Number K874049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1987
Decision Date October 29, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 79
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K874049.
ALBUMIN, BROMCRESOL GREEN DYE-BINDING
K875070 · Tech-Co, Inc. · Jan 1988
ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS
K874163 · Catachem, Inc. · Nov 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994 · Em Diagnostic Systems, Inc. · Oct 1987
ALBUMIN REAGENT - BROMCRESOL GREEN METHOD
K870372 · Trace Scientific , Ltd. · Aug 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715 · Em Diagnostic Systems, Inc. · Dec 1986
ALBUMIN PROCEDURE
K863263 · Data Medical Associates, Inc. · Sep 1986