Cleared Traditional

K981729 - IS-RUBELLA IGG TEST SYSTEM

K981729 is an FDA 510(k) clearance for IS-RUBELLA IGG TEST SYSTEM, manufactured by Diamedix Corp.. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K981729 · Diamedix Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
258d
Days
Class 2
Risk

K981729 is an FDA 510(k) clearance for the IS-RUBELLA IGG TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on January 28, 1999 after a review of 258 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 Diamedix Corp. devices

FDA 510(k) Submission Details - K981729

510(k) Number K981729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1998
Decision Date January 28, 1999
Days to Decision 258 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
156d slower than avg
Panel avg: 102d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFX Device Classification - Class 2, Special Controls

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 79
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K981729.
COPALIS RUBELLA IGM
K993291 · DiaSorin, Inc. · Feb 2000
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
K984180 · Zeus Scientific, Inc. · Jul 1999
THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
K983805 · Zeus Scientific, Inc. · May 1999
IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)
K982078 · Diagnostic Products Corp. · Dec 1998
SERAQUEST RUBELLA IGM
K982281 · Quest Intl., Inc. · Oct 1998
QUANTA LITE REBELLA IGG
K971304 · Inova Diagnostics, Inc. · Jan 1998