Cleared Traditional

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL (K182474) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182474 · Biosystems S.A. · Chemistry device
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May 2019
Decision
234d
Days
Class 2
Risk

K182474 is an FDA 510(k) clearance for the alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN .... Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Biosystems S.A. (Barcelona, ES). The FDA issued a Cleared decision on May 2, 2019 after a review of 234 days - an extended review 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: 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 Biosystems S.A. devices

Submission Details

510(k) Number K182474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2018
Decision Date May 02, 2019
Days to Decision 234 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 88d · This submission: 234d
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 98
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K182474.
Amylase2
K210633 · Abbott Ireland Diagnostics Division · May 2022
Atellica CH Amylase_2 (AMY_2)
K191454 · Siemens Healthcare Diagnostics, Inc. · Jul 2019
AMY
K981653 · Abbott Laboratories · Aug 1998
AMY
K981216 · Abbott Laboratories · Jun 1998
ABBOTT SPECTRUM AMYLASE REAGENT
K891241 · Abbott Laboratories · Aug 1989
A-GENT LIQUID AMYLASE
K873944 · Abbott Laboratories · Nov 1987