Cleared Traditional

K860918 - EASY-TEST AMLASE (AMYL)

K860918 is the FDA 510(k) clearance for EASY-TEST AMLASE (AMYL) by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K860918 · Em Diagnostic Systems, Inc. · Chemistry device
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Apr 1986
Decision
23d
Days
Class 2
Risk

K860918 is an FDA 510(k) clearance for the EASY-TEST AMLASE (AMYL), #67521/93. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on April 3, 1986 after a review of 23 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K860918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1986
Decision Date April 03, 1986
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFJ Catalytic Methods, 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 - JFJ Catalytic Methods, Amylase

All 72
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K860918.
RAICHEM AMYLASE REAGENT
K861269 · Reagents Applications, Inc. · May 1986
AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109
K861718 · Reagents Applications, Inc. · May 1986
ALPHA-AMYLASE TEST
K860665 · Sclavo, Inc. · Apr 1986
AMYLASE PRODUCTS
K850798 · Data Medical Associates, Inc. · Mar 1985
AMYLASE
K832889 · Pointe Scientific, Inc., · Nov 1983
AMYLAST-D TEST
K831561 · Sclavo, Inc. · Jul 1983