Cleared Traditional

K860145 - RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540

K860145 is an FDA 510(k) clearance for RUBELLA ELISA TEST SYSTEM CATALOG NUMBE..., manufactured by Clinical Sciences, Inc.. The device is a Class 2 Microbiology device with product code LFX cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K860145 · Clinical Sciences, Inc. · Microbiology device
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Jul 1986
Decision
180d
Days
Class 2
Risk

K860145 is an FDA 510(k) clearance for the RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Clinical Sciences, Inc. (Whippany, US). The FDA issued a Cleared decision on July 14, 1986 after a review of 180 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 Clinical Sciences, Inc. devices

FDA 510(k) Submission Details - K860145

510(k) Number K860145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1986
Decision Date July 14, 1986
Days to Decision 180 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
78d slower than avg
Panel avg: 102d · This submission: 180d
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 K860145.
VIRGO(TM) RUBELLA IGG ELISA
K873088 · Electro-Nucleonics Laboratories, Inc. · Sep 1987
RUBELLA MICROASSAY
K864602 · Diamedix Corp. · Apr 1987
RUBELLA IGM EIA TEST KIT
K862431 · Labsystems, Inc. · Aug 1986
RUBELLA IGG EIA TEST KIT
K853696 · Labsystems, Inc. · Jun 1986
CORDOT R
K854618 · Cordis Corp. · May 1986
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
K853069 · Hybritech, Inc. · Jan 1986