Cleared Traditional

K941091 - SYNERMED AMYLASE REAGENT KIT

K941091 is the FDA 510(k) clearance for SYNERMED AMYLASE REAGENT KIT by Synermed, Inc.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K941091 · Synermed, Inc. · Chemistry device
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May 1994
Decision
56d
Days
Class 2
Risk

K941091 is an FDA 510(k) clearance for the SYNERMED AMYLASE REAGENT KIT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on May 3, 1994 after a review of 56 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 Synermed, Inc. devices

Submission Details

510(k) Number K941091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1994
Decision Date May 03, 1994
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 88d · This submission: 56d
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 73
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K941091.
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
K971825 · Randox Laboratories, Ltd. · Jul 1997
CATALOGUE NUMBER 321-07/15/50
K945243 · Diagnostic Chemicals , Ltd. · Feb 1995
OLYMPUS AMYLASE REAGENT
K944229 · Olympus America, Inc. · Dec 1994
AMYLASE REAGENT SET (KINETIC)
K931080 · Teco Diagnostics · Nov 1993
ETHYLIDENE AMYL
K931582 · Em Diagnostic Systems, Inc. · Aug 1993
SILYL AMYL
K931583 · Em Diagnostic Systems, Inc. · Aug 1993