Cleared Traditional

K900230 - COULTER AMYLASE REAGENT

K900230 is the FDA 510(k) clearance for COULTER AMYLASE REAGENT by Coulter Corp.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K900230 · Coulter Corp. · Chemistry device
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Apr 1990
Decision
76d
Days
Class 2
Risk

K900230 is an FDA 510(k) clearance for the COULTER AMYLASE REAGENT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Coulter Corp. (Hialeah, US). The FDA issued a Cleared decision on April 3, 1990 after a review of 76 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 Coulter Corp. devices

Submission Details

510(k) Number K900230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1990
Decision Date April 03, 1990
Days to Decision 76 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
12d faster than avg
Panel avg: 88d · This submission: 76d
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 K900230.
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
K903332 · Em Diagnostic Systems, Inc. · Aug 1990
AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS
K902326 · Catachem, Inc. · Jul 1990
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
ABBOTT SPECTRUM AMYLASE REAGENT
K891241 · Abbott Laboratories · Aug 1989