Cleared Traditional

POC-AS10 AUTO SAMPLER (K092817) - FDA 510(k) Clearance

Class I Microbiology device.

K092817 · Otsuka Pharmaceutical Co., Ltd. · Microbiology device
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Optimized for regulatory review, auditing and printing
Mar 2010
Decision
176d
Days
Class 1
Risk

K092817 is an FDA 510(k) clearance for the POC-AS10 AUTO SAMPLER. Classified as Test, Urea (breath Or Blood) (product code MSQ), Class I - General Controls.

Submitted by Otsuka Pharmaceutical Co., Ltd. (North Attleboro, US). The FDA issued a Cleared decision on March 9, 2010 after a review of 176 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Otsuka Pharmaceutical Co., Ltd. devices

Submission Details

510(k) Number K092817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2009
Decision Date March 09, 2010
Days to Decision 176 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 102d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MSQ Test, Urea (breath Or Blood)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSQ Test, Urea (breath Or Blood)

All 16
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