Cleared Traditional

K092817 - POC-AS10 AUTO SAMPLER

K092817 is an FDA 510(k) clearance for POC-AS10 AUTO SAMPLER, manufactured by Otsuka Pharmaceutical Co., Ltd.. The device is a Class 1 Microbiology device with product code MSQ cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K092817 · Otsuka Pharmaceutical Co., Ltd. · Microbiology device
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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

FDA 510(k) Submission Details - K092817

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.

MSQ Device Classification - Class 1, General Controls

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 13
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