Cleared Traditional

TDX(R) AMYLASE II (K863622) - FDA 510(k) Clearance

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

K863622 · Abbott Laboratories · Chemistry device
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Oct 1986
Decision
17d
Days
Class 2
Risk

K863622 is an FDA 510(k) clearance for the TDX(R) AMYLASE II. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 3, 1986 after a review of 17 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 Abbott Laboratories devices

Submission Details

510(k) Number K863622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1986
Decision Date October 03, 1986
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
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 45
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K863622.
RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)
K871269 · Technicon Instruments Corp. · Apr 1987
QKO (TM) AMYLASE B-HA
K864303 · Wako Chemicals USA, Inc. · Dec 1986
VISION(TM) AMYLASE
K864435 · Abbott Laboratories · Dec 1986
EASY-TEST AMLASE (AMYL), #67521/93
K860918 · Em Diagnostic Systems, Inc. · Apr 1986
PARAMAX AMALINE REAGENT
K831536 · American Dade · Jun 1983
SINGLE VIAL AMYLASE PNP TEST
K823462 · Boehringer Mannheim Corp. · Dec 1982