Cleared Traditional

AMY REAGENT (K852001) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852001 · Alpkem Corp. · Chemistry device
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Jun 1985
Decision
34d
Days
Class 2
Risk

K852001 is an FDA 510(k) clearance for the AMY REAGENT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on June 10, 1985 after a review of 34 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 Alpkem Corp. devices

Submission Details

510(k) Number K852001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1985
Decision Date June 10, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
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 32
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K852001.
VISION(TM) AMYLASE
K864435 · Abbott Laboratories · Dec 1986
TDX(R) AMYLASE II
K863622 · Abbott Laboratories · Oct 1986
EASY-TEST AMLASE (AMYL), #67521/93
K860918 · Em Diagnostic Systems, Inc. · Apr 1986
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