Cleared Traditional

K905660 - SYSTEMATE ALBUMIN (EPOS APPLICATION) #6...

K905660 is the FDA 510(k) clearance for SYSTEMATE ALBUMIN (EPOS APPLICATION) #6... by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K905660 · Em Diagnostic Systems, Inc. · Chemistry device
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Jan 1991
Decision
38d
Days
Class 2
Risk

K905660 is an FDA 510(k) clearance for the SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on January 25, 1991 after a review of 38 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K905660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1990
Decision Date January 25, 1991
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
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 76
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K905660.
TECHNICON CHEM 1(TM) SYST (GEN2 SYST)
K914888 · Technicon Instruments Corp. · Nov 1991
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
K913920 · Em Diagnostic Systems, Inc. · Sep 1991
KODAK EKTACHEM DT SLIDES (ALB)
K913195 · Eastman Kodak Company · Aug 1991
SYNERMED ALBUMIN REAGENT KIT
K903543 · Synermed, Inc. · Oct 1990
COULTER ALBUMIN REAGENT
K901268 · Coulter Corp. · May 1990
COBAS READY ALBUMIN REAGENT
K896235 · Roche Diagnostic Systems, Inc. · Feb 1990