Cleared Traditional

K013101 - WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA

K013101 is an FDA 510(k) clearance for WIENER LAB. AMILASA 405 CINETICA AA, manufactured by Wiener Laboratories Saic. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K013101 · Wiener Laboratories Saic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
60d
Days
Class 2
Risk

K013101 is an FDA 510(k) clearance for the WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,.... Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on November 16, 2001 after a review of 60 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 Wiener Laboratories Saic devices

FDA 510(k) Submission Details - K013101

510(k) Number K013101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2001
Decision Date November 16, 2001
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFJ Device Classification - Class 2, Special Controls

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 93
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K013101.
WIENER LAB AMILASA 405 AA LIQUIDA
K023549 · Wiener Laboratories Saic · Dec 2002
JAS AMYLASE LIQUID REAGENT
K020282 · Jas Diagnostics, Inc. · Feb 2002
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
K013978 · Beckman Coulter, Inc. · Jan 2002
GENZYME DIRECT-AMYLASE TEST REAGENT
K011843 · Genzyme Corp. · Aug 2001
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145 · Roche Diagnostics Corp. · Jun 2001
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
K001569 · Sigma Diagnostics, Inc. · Jun 2000