Cleared Traditional

K013978 - SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT

K013978 is an FDA 510(k) clearance for SYNCHRON SYSTEMS PANCREATIC AMYLASE (PA..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K013978 · Beckman Coulter, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
43d
Days
Class 2
Risk

K013978 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on January 15, 2002 after a review of 43 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 Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K013978

510(k) Number K013978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2001
Decision Date January 15, 2002
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
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 K013978.
VITALAB AMYLASE REAGENT
K040534 · Clinical Data, Inc. · Mar 2004
WIENER LAB AMILASA 405 AA LIQUIDA
K023549 · Wiener Laboratories Saic · Dec 2002
JAS AMYLASE LIQUID REAGENT
K020282 · Jas Diagnostics, Inc. · Feb 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
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145 · Roche Diagnostics Corp. · Jun 2001