Cleared Traditional

HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY (K130685) - FDA 510(k) Clearance

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

K130685 · Hitachi Chemical Diagnostics, Inc. · Chemistry device
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Aug 2013
Decision
149d
Days
Class 2
Risk

K130685 is an FDA 510(k) clearance for the HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Hitachi Chemical Diagnostics, Inc. (Los Angeles, US). The FDA issued a Cleared decision on August 9, 2013 after a review of 149 days - within the typical 510(k) review window.

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 Hitachi Chemical Diagnostics, Inc. devices

Submission Details

510(k) Number K130685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2013
Decision Date August 09, 2013
Days to Decision 149 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 88d · This submission: 149d
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 49
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K130685.
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