Cleared Traditional

K885295 - IMX RUBELLA IGM

K885295 is an FDA 510(k) clearance for IMX RUBELLA IGM, manufactured by Abbott Laboratories. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K885295 · Abbott Laboratories · Microbiology device
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Jun 1989
Decision
178d
Days
Class 2
Risk

K885295 is an FDA 510(k) clearance for the IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 178 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K885295

510(k) Number K885295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1988
Decision Date June 23, 1989
Days to Decision 178 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
76d slower than avg
Panel avg: 102d · This submission: 178d
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 K885295.
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
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
K885297 · Abbott Laboratories · Jun 1989
RUBELLA-CUBE(TM)
K892051 · Difco Laboratories, Inc. · Jun 1989
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
K884617 · Ortho Diagnostic Systems, Inc. · Feb 1989