Cleared Traditional

K901017 - DU PONT ANALYST ANALYTICAL TEST ROTOR:C...

K901017 is the FDA 510(k) clearance for DU PONT ANALYST ANALYTICAL TEST ROTOR:C... by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K901017 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
71d
Days
Class 2
Risk

K901017 is an FDA 510(k) clearance for the DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on May 15, 1990 after a review of 71 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K901017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1990
Decision Date May 15, 1990
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 K901017.
ROCHE COBAS READY AMYLASE REAGENT
K903309 · Roche Diagnostic Systems, Inc. · Sep 1990
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
K903332 · Em Diagnostic Systems, Inc. · Aug 1990
AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS
K902326 · Catachem, Inc. · Jul 1990
COULTER AMYLASE REAGENT
K900230 · Coulter Corp. · Apr 1990
AMYLASE REAGENT
K896650 · Sigma Chemical Co. · Feb 1990
AMYLASE TEST (AML) ITEM NUMBER: 65404
K893751 · Em Diagnostic Systems, Inc. · Aug 1989