Cleared Traditional

K001569 - INFINITY AMYLASE REAGENT (PROCEDURE NO....

K001569 is the FDA 510(k) clearance for INFINITY AMYLASE REAGENT (PROCEDURE NO.... by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K001569 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
38d
Days
Class 2
Risk

K001569 is an FDA 510(k) clearance for the INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568). Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 26, 2000 after a review of 38 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K001569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2000
Decision Date June 26, 2000
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
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 K001569.
VITALAB AMYLASE REAGENT
K040534 · Clinical Data, Inc. · Mar 2004
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
K013978 · Beckman Coulter, Inc. · Jan 2002
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145 · Roche Diagnostics Corp. · Jun 2001
WAKO L-TYPE AMYLASE
K984184 · Wako Chemicals USA, Inc. · Jan 1999
AMY
K981653 · Abbott Laboratories · Aug 1998
AMY
K981216 · Abbott Laboratories · Jun 1998