Cleared Special

K130628 - PATHFAST CK-MB-II CALIBRATORS

K130628 is an FDA 510(k) clearance for PATHFAST CK-MB-II 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 210-day FDA review.

K130628 · Mitsubishi Chemical Medience Corporation · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
210d
Days
Class 2
Risk

K130628 is an FDA 510(k) clearance for the PATHFAST CK-MB-II 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 October 4, 2013 after a review of 210 days - an extended review cycle.

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. Standard predicate reliance. 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 - K130628

510(k) Number K130628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2013
Decision Date October 04, 2013
Days to Decision 210 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
121d slower than avg
Panel avg: 89d · This submission: 210d
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 K130628.
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K130628 · PATHFAST CK-MB-II CALIBRATORS
Download PDF FDA Summary Mitsubishi Chemical M…