Cleared Special

K040920 - AMYLASE LIQUID REAGENT

K040920 is an FDA 510(k) clearance for AMYLASE LIQUID REAGENT, manufactured by Teco Diagnostics. The device is a Class 2 Chemistry device with product code JFJ cleared through the Special 510(k) pathway after a 32-day FDA review.

K040920 · Teco Diagnostics · Chemistry device
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May 2004
Decision
32d
Days
Class 2
Risk

K040920 is an FDA 510(k) clearance for the AMYLASE LIQUID REAGENT, MODEL A532-200. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on May 10, 2004 after a review of 32 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Teco Diagnostics devices

FDA 510(k) Submission Details - K040920

510(k) Number K040920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2004
Decision Date May 10, 2004
Days to Decision 32 days
Submission Type Special
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
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Modification to existing cleared device.

JFJ Device Classification - Class 2, Special Controls

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 90
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K040920.
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
K080823 · Medica Corp. · Nov 2008
AMYLASE EPS REAGENT
K070064 · Thermo Fisher Scientific · May 2007
ABX PENTRA AMYLASE CP
K062180 · Horiba Abx · Oct 2006
VITALAB AMYLASE REAGENT
K040534 · Clinical Data, Inc. · Mar 2004
WIENER LAB AMILASA 405 AA LIQUIDA
K023549 · Wiener Laboratories Saic · Dec 2002
JAS AMYLASE LIQUID REAGENT
K020282 · Jas Diagnostics, Inc. · Feb 2002