Cleared Traditional

K862370 - DART AMYLASE-D.S. REAGENT SYSTEM

K862370 is the FDA 510(k) clearance for DART AMYLASE-D.S. REAGENT SYSTEM by Coulter Electronics, Inc.. It is a Class 2 Chemistry device (product code CIJ) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K862370 · Coulter Electronics, Inc. · Chemistry device
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Aug 1986
Decision
38d
Days
Class 2
Risk

K862370 is an FDA 510(k) clearance for the DART AMYLASE-D.S. REAGENT SYSTEM. Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on August 1, 1986 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1070 - 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 Coulter Electronics, Inc. devices

Submission Details

510(k) Number K862370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1986
Decision Date August 01, 1986
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 CIJ Saccharogenic, Amylase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1070
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 - CIJ Saccharogenic, Amylase

All 28
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K862370.
D.A.T. (TM) AMYLASE REAGENT
K871943 · Behring Diagnostics, Inc. · Jun 1987
AMYLASE REAGENT
K864356 · Trace Scientific , Ltd. · Jan 1987
AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1
K863719 · Technicon Instruments Corp. · Nov 1986
AMYLASE PROCEDURE
K861664 · Data Medical Associates, Inc. · Jul 1986
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
K860935 · Em Diagnostic Systems, Inc. · May 1986
ISOTRAK AMYLASE TEST AMYLASE ISOENZYME
K853951 · Behring Diagnostics, Inc. · Jan 1986