Cleared Traditional

K090940 - SPOTCHECK BLOOD SPOT CONTROL, ASSAYED (FDA 510(k) Clearance)

Class I Chemistry device.

K090940 · Astoria-Pacific, Inc. · Chemistry device
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Dec 2009
Decision
255d
Days
Class 1
Risk

K090940 is an FDA 510(k) clearance for the SPOTCHECK BLOOD SPOT CONTROL, ASSAYED. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Astoria-Pacific, Inc. (Clackamas, US). The FDA issued a Cleared decision on December 14, 2009 after a review of 255 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Astoria-Pacific, Inc. devices

Submission Details

510(k) Number K090940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2009
Decision Date December 14, 2009
Days to Decision 255 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
167d slower than avg
Panel avg: 88d · This submission: 255d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.