Cleared Traditional

K153417 - ST AIA-PACK PROG III Calibrator Set

K153417 is the FDA 510(k) clearance for ST AIA-PACK PROG III Calibrator Set by Tosoh Bioscience, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K153417 · Tosoh Bioscience, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
23d
Days
Class 2
Risk

K153417 is an FDA 510(k) clearance for the ST AIA-PACK PROG III 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 December 18, 2015 after a review of 23 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tosoh Bioscience, Inc. devices

Submission Details

510(k) Number K153417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2015
Decision Date December 18, 2015
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 160
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K153417.
Lumipulse G Prolactin
K163544 · Fujirebio Diagnostics,Inc. · Jan 2017
Lumipulse G E2-III Calibrators
K163053 · Fujirebio Diagnostics,Inc. · Dec 2016
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
K162538 · Siemens Healthcare Diagnostics · Nov 2016
Elecsys Progesterone III CalSet
K152526 · Roche Diagnostics · Oct 2015
Abbott ARCHITECT Total T4 Calibrators
K151566 · Abbott Laboratories · Jul 2015
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
K142985 · Beckman Coulter, Inc. · Feb 2015