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 an FDA 510(k) clearance for IMMULITE 2000, manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 1 Immunology device with 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

FDA 510(k) Submission Details - K133122

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
75d faster than avg
Panel avg: 105d · This submission: 30d
Pathway characteristics
Standards-based clearance path.

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 445
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
RIGHTEST CONTROL SOLUTION
K133003 · Bionime Corporation · Oct 2013
IMMULITE 2000
K133128 · Siemens Healthcare Diagnostics, Inc. · Oct 2013