Cleared Traditional

K123127 - VALIDATE PSA CALIBRATION VERIFICATION/ ...

K123127 is the FDA 510(k) clearance for VALIDATE PSA CALIBRATION VERIFICATION/ ... by Maine Standards Co.. It is a Class 1 Immunology device (product code JJX) cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K123127 · Maine Standards Co. · Immunology device
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Jun 2013
Decision
253d
Days
Class 1
Risk

K123127 is an FDA 510(k) clearance for the VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Maine Standards Co. (Windham, US). The FDA issued a Cleared decision on June 14, 2013 after a review of 253 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Maine Standards Co. devices

Submission Details

510(k) Number K123127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2012
Decision Date June 14, 2013
Days to Decision 253 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 104d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte 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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 371
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K123127.
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