Cleared Traditional

K885082 - IMMUNODOT RUBELLA TEST

K885082 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 55-day FDA review.

K885082 · General Biometrics, Inc. · Microbiology device
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Feb 1989
Decision
55d
Days
Class 2
Risk

K885082 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 February 2, 1989 after a review of 55 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 - K885082

510(k) Number K885082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1988
Decision Date February 02, 1989
Days to Decision 55 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
47d faster than avg
Panel avg: 102d · This submission: 55d
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 K885082.
RUBELLA-CUBE(TM)
K892051 · Difco Laboratories, Inc. · Jun 1989
IMMUNODOT TORCH TEST RUBELLA
K884898 · General Biometrics, Inc. · Feb 1989
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
K884617 · Ortho Diagnostic Systems, Inc. · Feb 1989
RUBENOSTIKA(TM) IGM MICROELISA SYSTEM
K882999 · Organon Teknika Corp. · Jan 1989
RUBELLA IGM MICROASSAY
K883778 · Diamedix Corp. · Oct 1988
AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200
K882475 · Amersham Corp. · Oct 1988