Cleared Traditional

K011145 - MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658

K011145 is an FDA 510(k) clearance for MODIFICATION TO REFLOTRON AMYLASE, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K011145 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
91d
Days
Class 2
Risk

K011145 is an FDA 510(k) clearance for the MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on June 25, 2001 after a review of 91 days - within the typical 510(k) review window.

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 Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K011145

510(k) Number K011145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2001
Decision Date June 25, 2001
Days to Decision 91 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
3d slower than avg
Panel avg: 88d · This submission: 91d
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 92
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K011145.
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
K013978 · Beckman Coulter, Inc. · Jan 2002
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA
K013101 · Wiener Laboratories Saic · Nov 2001
GENZYME DIRECT-AMYLASE TEST REAGENT
K011843 · Genzyme Corp. · Aug 2001
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
K001569 · Sigma Diagnostics, Inc. · Jun 2000
CARESIDE AMYLASE
K990025 · Careside, Inc. · Feb 1999
WAKO L-TYPE AMYLASE
K984184 · Wako Chemicals USA, Inc. · Jan 1999