Cleared Traditional

K130685 - HITACHI CLINICAL ANALYZER S TEST REAGEN...

K130685 is an FDA 510(k) clearance for HITACHI CLINICAL ANALYZER S TEST REAGEN..., manufactured by Hitachi Chemical Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K130685 · Hitachi Chemical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K130685

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.

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 83
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
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
K080823 · Medica Corp. · Nov 2008
AMYLASE EPS REAGENT
K070064 · Thermo Fisher Scientific · May 2007