Cleared Traditional

K090940 - SPOTCHECK BLOOD SPOT CONTROL

K090940 is the FDA 510(k) clearance for SPOTCHECK BLOOD SPOT CONTROL by Astoria-Pacific, Inc.. It is a Class 1 Chemistry device (product code JJT) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K090940 · Astoria-Pacific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

Regulatory Peers - JJT Enzyme Controls (assayed And Unassayed)

All 59
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K090940.
MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
K062751 · Quantimetrix Corp. · Oct 2006
CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
K030768 · Cliniqa Corporation · Mar 2003
ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
K030102 · Bayer Healthcare, LLC · Jan 2003
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
K021498 · Bio-Rad · May 2002
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
K012656 · Bio-Rad · Sep 2001
CARDIASURE CARDIAC MARKERS CONTROL
K993723 · Quantimetrix Corp. · Nov 1999