Cleared Traditional

K864303 - QKO (TM) AMYLASE B-HA

K864303 is the FDA 510(k) clearance for QKO (TM) AMYLASE B-HA by Wako Chemicals USA, Inc.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K864303 · Wako Chemicals USA, Inc. · Chemistry device
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Dec 1986
Decision
61d
Days
Class 2
Risk

K864303 is an FDA 510(k) clearance for the QKO (TM) AMYLASE B-HA. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on December 31, 1986 after a review of 61 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 Wako Chemicals USA, Inc. devices

Submission Details

510(k) Number K864303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1986
Decision Date December 31, 1986
Days to Decision 61 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
27d faster than avg
Panel avg: 88d · This submission: 61d
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 K864303.
RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)
K871269 · Technicon Instruments Corp. · Apr 1987
AMYLASE COLORIMETRIC PROCEDURE
K864825 · Data Medical Associates, Inc. · Feb 1987
PSI AMYLASE REAGENT
K864464 · Pointe Scientific, Inc., · Jan 1987
VISION(TM) AMYLASE
K864435 · Abbott Laboratories · Dec 1986
TDX(R) AMYLASE II
K863622 · Abbott Laboratories · Oct 1986
AMYLASE SR LIQUID STABLE REAGENT SET
K862733 · Medical Analysis Systems, Inc. · Sep 1986