Cleared Abbreviated

K111938 - IDS-ISYS IGFBP-3 CONTROL SET

K111938 is the FDA 510(k) clearance for IDS-ISYS IGFBP-3 CONTROL SET by Immunodiagnostic Systems , Ltd.. It is a Class 1 Chemistry device (product code JJX) cleared through the Abbreviated 510(k) pathway after a 221-day FDA review.

K111938 · Immunodiagnostic Systems , Ltd. · Chemistry device
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Feb 2012
Decision
221d
Days
Class 1
Risk

K111938 is an FDA 510(k) clearance for the IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION.... Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Immunodiagnostic Systems , Ltd. (Boldon, Tyne & Wear, GB). The FDA issued a Cleared decision on February 14, 2012 after a review of 221 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Immunodiagnostic Systems , Ltd. devices

Submission Details

510(k) Number K111938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2011
Decision Date February 14, 2012
Days to Decision 221 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 88d · This submission: 221d
Pathway characteristics
Standards-based clearance path.

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)

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