Cleared Traditional

AMYLASE (K930678) - FDA 510(k) Clearance

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

K930678 · Horizon Diagnostics, Inc. · Chemistry device
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Apr 1994
Decision
421d
Days
Class 2
Risk

K930678 is an FDA 510(k) clearance for the AMYLASE. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Horizon Diagnostics, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on April 6, 1994 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Horizon Diagnostics, Inc. devices

Submission Details

510(k) Number K930678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1993
Decision Date April 06, 1994
Days to Decision 421 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
333d slower than avg
Panel avg: 88d · This submission: 421d
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 K930678.
Amylase2
K210633 · Abbott Ireland Diagnostics Division · May 2022
Atellica CH Amylase_2 (AMY_2)
K191454 · Siemens Healthcare Diagnostics, Inc. · Jul 2019
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
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
K013978 · Beckman Coulter, Inc. · Jan 2002
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
K011145 · Roche Diagnostics Corp. · Jun 2001