Cleared Special

K130603 - PATHFAST CTNL CALIBRATORS

K130603 is an FDA 510(k) clearance for PATHFAST CTNL CALIBRATORS, manufactured by Mitsubishi Chemical Medience Corporation. The device is a Class 2 Chemistry device with product code JIT cleared through the Special 510(k) pathway after a 385-day FDA review.

K130603 · Mitsubishi Chemical Medience Corporation · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
385d
Days
Class 2
Risk

K130603 is an FDA 510(k) clearance for the PATHFAST CTNL CALIBRATORS. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Mitsubishi Chemical Medience Corporation (Bethesda, US). The FDA issued a Cleared decision on March 27, 2014 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K130603

510(k) Number K130603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2013
Decision Date March 27, 2014
Days to Decision 385 days
Submission Type Special
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
296d slower than avg
Panel avg: 89d · This submission: 385d
Pathway characteristics
Modification to existing cleared device.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 244
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K130603.
BICARBONATE CALIBRATOR
K141374 · Beckman Coulter Ireland, Inc. · Jun 2014
CA 125 II CALSET II
K140112 · Roche Diagnostics · Jun 2014
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
K140648 · Tosoh Bioscience, Inc. · Apr 2014
LP(A) CALIBRATORS, AND LP(A) CONTROLS
K132400 · Biokit, S.A. · Dec 2013
PATHFAST CK-MB-II CALIBRATORS
K130628 · Mitsubishi Chemical Medience Corporation · Oct 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
K131556 · Diazyme Laboratories · Jun 2013
K130603 · PATHFAST CTNL CALIBRATORS
Download PDF FDA Summary Mitsubishi Chemical M…