Cleared Traditional

K821459 - ULTRAZYME PLUS AMYL #65031&64982

K821459 is the FDA 510(k) clearance for ULTRAZYME PLUS AMYL #65031&64982 by Emd Chemicals, Inc.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K821459 · Emd Chemicals, Inc. · Chemistry device
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May 1982
Decision
10d
Days
Class 2
Risk

K821459 is an FDA 510(k) clearance for the ULTRAZYME PLUS AMYL #65031&64982. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982 after a review of 10 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 Emd Chemicals, Inc. devices

Submission Details

510(k) Number K821459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1982
Decision Date May 28, 1982
Days to Decision 10 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
78d faster than avg
Panel avg: 88d · This submission: 10d
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 K821459.
AMYLAST-D TEST
K831561 · Sclavo, Inc. · Jul 1983
PARAMAX AMALINE REAGENT
K831536 · American Dade · Jun 1983
SINGLE VIAL AMYLASE PNP TEST
K823462 · Boehringer Mannheim Corp. · Dec 1982
BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY
K802581 · Beckman Instruments, Inc. · Nov 1980
DELTA TEST AMYLASE UV
K800049 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1980
GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL
K772035 · Harleco · Nov 1977