Cleared Traditional

K894546 - IMMUNODOT RUBELLA TEST

K894546 is an FDA 510(k) clearance for IMMUNODOT RUBELLA TEST, manufactured by General Biometrics, Inc.. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K894546 · General Biometrics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
87d
Days
Class 2
Risk

K894546 is an FDA 510(k) clearance for the IMMUNODOT RUBELLA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 16, 1989 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Biometrics, Inc. devices

FDA 510(k) Submission Details - K894546

510(k) Number K894546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1989
Decision Date October 16, 1989
Days to Decision 87 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
15d faster than avg
Panel avg: 102d · This submission: 87d
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 68
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K894546.
RUBELLA IGG ELISA TEST
K901635 · Gull Laboratories, Inc. · Jun 1990
ORTHO* RUBELLA-G ANTIBODY ELISA TEST
K896479 · Ortho Diagnostic Systems, Inc. · Dec 1989
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
RUBELLA ELISA TEST SYSTEM
K891783 · Zeus Scientific, Inc. · Aug 1989