Cleared Traditional

ABBOTT SPECTRUM AMYLASE REAGENT (K891241) - FDA 510(k) Clearance

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

K891241 · Abbott Laboratories · Chemistry device
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Aug 1989
Decision
161d
Days
Class 2
Risk

K891241 is an FDA 510(k) clearance for the ABBOTT SPECTRUM AMYLASE REAGENT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on August 15, 1989 after a review of 161 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

Submission Details

510(k) Number K891241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1989
Decision Date August 15, 1989
Days to Decision 161 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
73d slower than avg
Panel avg: 88d · This submission: 161d
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 K891241.
DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI
K901017 · E.I. Dupont DE Nemours & Co., Inc. · May 1990
AMYLASE REAGENT
K896650 · Sigma Chemical Co. · Feb 1990
AMYLASE TEST (AML) ITEM NUMBER: 65404
K893751 · Em Diagnostic Systems, Inc. · Aug 1989
PANCREATIC A-AMYLASE PNP
K892848 · Boehringer Mannheim Corp. · Jul 1989
REFLOTRON (R) AMYLASE
K874704 · Boehringer Mannheim Corp. · Jan 1988
A-GENT LIQUID AMYLASE
K873944 · Abbott Laboratories · Nov 1987