Cleared Abbreviated

K140648 - ST AIA-PACK C-PEPTIDE II CALIBRATOR SET

K140648 is an FDA 510(k) clearance for ST AIA-PACK C-PEPTIDE II CALIBRATOR SET, manufactured by Tosoh Bioscience, Inc.. The device is a Class 2 Chemistry device with product code JIT cleared through the Abbreviated 510(k) pathway after a 28-day FDA review.

K140648 · Tosoh Bioscience, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
28d
Days
Class 2
Risk

K140648 is an FDA 510(k) clearance for the ST AIA-PACK C-PEPTIDE II CALIBRATOR SET. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Tosoh Bioscience, Inc. (South San Franciso, US). The FDA issued a Cleared decision on April 10, 2014 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Tosoh Bioscience, Inc. devices

FDA 510(k) Submission Details - K140648

510(k) Number K140648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2014
Decision Date April 10, 2014
Days to Decision 28 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Standards-based clearance path.

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 187
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K140648.
Elecsys Estradiol III CalSet
K142021 · Roche Diagnostics · Aug 2014
DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
K133751 · Diamond Diagnostics, Inc. · Aug 2014
CA 125 II CALSET II
K140112 · Roche Diagnostics · Jun 2014
LP(A) CALIBRATORS, AND LP(A) CONTROLS
K132400 · Biokit, S.A. · Dec 2013
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET
K131556 · Diazyme Laboratories · Jun 2013
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
K130698 · Siemens Healthcare Diagnostics · Apr 2013