Cleared Traditional

K191454 - Atellica CH Amylase_2 (AMY_2)

K191454 is the FDA 510(k) clearance for Atellica CH Amylase_2 (AMY_2) by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K191454 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
60d
Days
Class 2
Risk

K191454 is an FDA 510(k) clearance for the Atellica CH Amylase_2 (AMY_2). Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on July 30, 2019 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 Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K191454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2019
Decision Date July 30, 2019
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.

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 K191454.
Amylase2
K210633 · Abbott Ireland Diagnostics Division · May 2022
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
K182474 · Biosystems S.A. · May 2019
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
K091846 · Beckman Coulter, Inc. · Oct 2009
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
K080823 · Medica Corp. · Nov 2008
AMYLASE EPS REAGENT
K070064 · Thermo Fisher Scientific · May 2007
AMYLASE LIQUID REAGENT, MODEL A532-200
K040920 · Teco Diagnostics · May 2004