Cleared Abbreviated

K141444 - IMMULITE 2000

Also marketed or referenced as:
CORTISOL CALIBRATION VERIFICATION MATERIAL, FOLIC ACID CALIBRATION VERIFICATION MATERIAL, VITAMIN B12 CAL

K141444 is the FDA 510(k) clearance for IMMULITE 2000 by Siemens Healthcare Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Abbreviated 510(k) pathway after a 37-day FDA review.

K141444 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
37d
Days
Class 1
Risk

K141444 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. (Los Angeles, US). The FDA issued a Cleared decision on July 9, 2014 after a review of 37 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 K141444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2014
Decision Date July 09, 2014
Days to Decision 37 days
Submission Type Abbreviated
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
51d faster than avg
Panel avg: 88d · This submission: 37d
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)

All 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K141444.
ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)
K142864 · Siemens Healthcare Diagnostics, Inc. · Oct 2014
ELECSYS ESTRADIOL III CALCHECK 5
K142127 · Roche Diagnostics · Sep 2014
IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL
K141772 · Siemens Healthcare Diagnostics, Inc. · Aug 2014
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
K133816 · Siemens Healthcare Diagnostics, Inc. · Jun 2014
IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C
K140818 · Siemens Healthcare Diagnostics, Inc. · May 2014
IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C
K140541 · Siemens Healthcare Diagnostics, Inc. · Apr 2014