Cleared Abbreviated

K111762 - ST AIA-PACK DHEA-S CALIBRATOR SET

K111762 is an FDA 510(k) clearance for ST AIA-PACK DHEA-S 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 43-day FDA review.

K111762 · Tosoh Bioscience, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
43d
Days
Class 2
Risk

K111762 is an FDA 510(k) clearance for the ST AIA-PACK DHEA-S 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 August 5, 2011 after a review of 43 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 - K111762

510(k) Number K111762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2011
Decision Date August 05, 2011
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
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 K111762.
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