Cleared Traditional

K053247 - VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET

K053247 is an FDA 510(k) clearance for VALIDATE CARDIAC MARKER (CM1) CALIBRATI..., manufactured by Maine Standards Co.. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K053247 · Maine Standards Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
53d
Days
Class 1
Risk

K053247 is an FDA 510(k) clearance for the VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Maine Standards Co. (Windham, US). The FDA issued a Cleared decision on January 13, 2006 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Maine Standards Co. devices

FDA 510(k) Submission Details - K053247

510(k) Number K053247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2005
Decision Date January 13, 2006
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 88d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 593
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K053247.
CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2
K061182 · Cliniqa Corporation · May 2006
MISSION COMPLETE
K060206 · Diamond Diagnostics, Inc. · Mar 2006
TDM CONTROL SET
K060429 · Roche Diagnostics Corp. · Mar 2006
ELECSYS PRECICONTROL BONE
K051543 · Roche Diagnostics Corp. · Oct 2005
AUTOCHECK6+
K051928 · Radiometer Medical Aps · Oct 2005
ELECSYS PRECICONTROL UNIVERSAL
K051687 · Roche Diagnostics Corp. · Jul 2005