Cleared Abbreviated

K133124 - IMMULITE 2000 (FDA 510(k) Clearance)

Also includes:
TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA

Class I Chemistry device.

K133124 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
25d
Days
Class 1
Risk

K133124 is an FDA 510(k) clearance for the IMMULITE 2000. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on October 25, 2013 after a review of 25 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 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 Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K133124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date October 25, 2013
Days to Decision 25 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
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.