Cleared Abbreviated

K133122 - IMMULITE 2000

Also marketed or referenced as:
3GALLERGY SPECIFIC IGE CONTROL VERIFICATION MATERIAL (CVM), TOTAL IGE CONTROL VERIFICATION MATERIAL (CVM)

K133122 is the FDA 510(k) clearance for IMMULITE 2000 by Siemens Healthcare Diagnostics, Inc.. It is a Class 1 Immunology device (product code JJX) cleared through the Abbreviated 510(k) pathway after a 30-day FDA review.

K133122 · Siemens Healthcare Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
30d
Days
Class 1
Risk

K133122 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 30, 2013 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology device 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 K133122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date October 30, 2013
Days to Decision 30 days
Submission Type Abbreviated
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
74d faster than avg
Panel avg: 104d · This submission: 30d
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 K133122.
FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO CODE
K133197 · Fujirebio Diagnostics,Inc. · Jan 2014
IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL
K132739 · Siemens Healthcare Diagnostics, Inc. · Jan 2014
ELECSYS CK-MB CALCHECK 5
K133284 · Roche Diagnostics · Nov 2013
IMMULITE 2000
K133124 · Siemens Healthcare Diagnostics, Inc. · Oct 2013
IMMULITE 2000
K133128 · Siemens Healthcare Diagnostics, Inc. · Oct 2013
IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL
K131662 · Siemens Healthcare Diagnostics, Inc. · Oct 2013