Cleared Traditional

K963613 - IMMULITE RUBELLA IGG

K963613 is the FDA 510(k) clearance for IMMULITE RUBELLA IGG by Diagnostic Products Corp.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K963613 · Diagnostic Products Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
204d
Days
Class 2
Risk

K963613 is an FDA 510(k) clearance for the IMMULITE RUBELLA IGG. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 204 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K963613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1996
Decision Date April 02, 1997
Days to Decision 204 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 102d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFX Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
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 Microbiology devices follow this clearance model.

Regulatory Peers - LFX Enzyme Linked Immunoabsorbent Assay, Rubella

All 59
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K963613.
IS-RUBELLA IGG TEST SYSTEM
K981729 · Diamedix Corp. · Jan 1999
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)
K982078 · Diagnostic Products Corp. · Dec 1998
QUANTA LITE REBELLA IGG
K971304 · Inova Diagnostics, Inc. · Jan 1998
RUBASCAN CARD TEST
K952721 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1996
INCSTAR RUBELLA IGG FAST ELISA ASSAY
K960358 · Incstar Corp. · Oct 1996
INCSTAR RUBELLA IGG ELISA ASSAY
K960367 · Incstar Corp. · Oct 1996