Cleared Traditional

DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER (K884378) - FDA 510(k) Clearance

Class I Chemistry device.

K884378 · Coulter Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
132d
Days
Class 1
Risk

K884378 is an FDA 510(k) clearance for the DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Coulter Corp. (Hialeah, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Coulter Corp. devices

Submission Details

510(k) Number K884378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1988
Decision Date February 27, 1989
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 207
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K884378.
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
K183375 · Horiba, Ltd. · Feb 2019
DIMENSION VISTA INTEGRATED SYSTEM
K051087 · Dade Behring, Inc. · Jul 2005
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
K023764 · Beckman Coulter, Inc. · Jan 2003
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
K974779 · Abbott Laboratories · Feb 1998
ABBOTT AXSYM SYSTEM
K974651 · Abbott Laboratories · Feb 1998
SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L
K965240 · Beckman Instruments, Inc. · Mar 1997