Cleared Traditional

K233946 - IMMULITE® 2000 BR-MA

K233946 is an FDA 510(k) clearance for IMMULITE 2000 BR-MA, manufactured by Siemens Healthcare Diagnostics Products, Ltd.. The device is a Class 2 Immunology device with product code MOI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K233946 · Siemens Healthcare Diagnostics Products, Ltd. · Immunology device
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Mar 2024
Decision
90d
Days
Class 2
Risk

K233946 is an FDA 510(k) clearance for the IMMULITE® 2000 BR-MA. Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics Products, Ltd. (Llanberis, GB). The FDA issued a Cleared decision on March 13, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics Products, Ltd. devices

FDA 510(k) Submission Details - K233946

510(k) Number K233946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2023
Decision Date March 13, 2024
Days to Decision 90 days
Submission Type Traditional
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
15d faster than avg
Panel avg: 105d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOI Device Classification - Class 2, Special Controls

Product Code MOI System, Test, Immunological, Antigen, Tumor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - MOI System, Test, Immunological, Antigen, Tumor

All 27
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