Cleared Traditional

K123127 - VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406

K123127 is an FDA 510(k) clearance for VALIDATE PSA CALIBRATION VERIFICATION/ ..., manufactured by Maine Standards Co.. The device is a Class 1 Immunology device with 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

FDA 510(k) Submission Details - K123127

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 105d · This submission: 253d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

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 444
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K123127.
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