Cleared Traditional

K133519 - CAROLINA LIQUID CHEMISTRIES CLC 6410 CH...

Also marketed or referenced as:
CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR

K133519 is an FDA 510(k) clearance for CAROLINA LIQUID CHEMISTRIES CLC 6410 CH..., manufactured by Carolina Liquid Chemistries Corp.. The device is a Class 1 Chemistry device with product code JJE cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K133519 · Carolina Liquid Chemistries Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
182d
Days
Class 1
Risk

K133519 is an FDA 510(k) clearance for the CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Carolina Liquid Chemistries Corp. (Winston-Salem, US). The FDA issued a Cleared decision on May 16, 2014 after a review of 182 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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 Carolina Liquid Chemistries Corp. devices

FDA 510(k) Submission Details - K133519

510(k) Number K133519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2013
Decision Date May 16, 2014
Days to Decision 182 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
94d slower than avg
Panel avg: 88d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

JJE Device Classification - Class 1, General Controls

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 151
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K133519.
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
K183375 · Horiba, Ltd. · Feb 2019
XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
K130915 · Jas Diagnostics, Inc. · May 2014
RX DAYTONA PLUS CHEMISTRY ANALYZER
K131554 · Randox Laboratories, Ltd. · Jan 2014
DIMENSION EXL WITH LM SYSTEM
K130276 · Siemens Healthcare Diagnostics, Inc. · Mar 2013
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT
K113253 · Alfa Wassermann Diagnostic Technologies, Inc. · May 2012
DIMENSION CLINICAL CHEMISTRY SYSTEM
K112999 · Siemens Healthcare Diagnostics · Nov 2011