Cleared Traditional

K891783 - RUBELLA ELISA TEST SYSTEM

K891783 is an FDA 510(k) clearance for RUBELLA ELISA TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K891783 · Zeus Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
132d
Days
Class 2
Risk

K891783 is an FDA 510(k) clearance for the RUBELLA ELISA TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 132 days - within the typical 510(k) review window.

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 Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K891783

510(k) Number K891783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1989
Decision Date August 03, 1989
Days to Decision 132 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 102d · This submission: 132d
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 65
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K891783.
PLATELIA RUBELLA IGG KIT
K894946 · Kallestad Diag, A Div. of Erbamont, Inc. · Dec 1989
DETECTADOT(TM) SYSTEM 2000 RUBELLA IGG TEST
K892202 · Gull Laboratories, Inc. · Sep 1989
BIOTROL RUB-E.I.A. TEST G
K894544 · Biotrol, USA, Inc. · Aug 1989
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
K885295 · Abbott Laboratories · Jun 1989
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
K885297 · Abbott Laboratories · Jun 1989
RUBELLA-CUBE(TM)
K892051 · Difco Laboratories, Inc. · Jun 1989