Cleared Traditional

K013984 - IMMULITE BR-MA

Also marketed or referenced as:
IMMULITE 2000 BR-MA, MODEL #L2KBR

K013984 is the FDA 510(k) clearance for IMMULITE BR-MA by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code MOI) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K013984 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
115d
Days
Class 2
Risk

K013984 is an FDA 510(k) clearance for the IMMULITE BR-MA, MODEL #LKBR. Classified as System, Test, Immunological, Antigen, Tumor (product code MOI), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 28, 2002 after a review of 115 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K013984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2001
Decision Date March 28, 2002
Days to Decision 115 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
11d slower than avg
Panel avg: 104d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 17
Devices cleared under the same product code (MOI) and FDA review panel - the closest regulatory comparables to K013984.
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
K072612 · Beckman Coulter, Inc. · Oct 2007
ARCHITECT CA 15-3 ASSAY
K042732 · Fujirebio Diagnostics,Inc. · Dec 2004
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647
K033036 · Beckman Coulter, Inc. · Feb 2004
ELECSYSCA 15-3 II ASSAY
K010588 · Roche Diagnostics Corp. · Mar 2001
ELECSYS CA 15-3 TEST SYSTEM
K001468 · Roche Diagnostics Corp. · Oct 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 REAGENT PACK
K983690 · Ortho-Clinical Diagnostics, Inc. · Feb 1999