Cleared Traditional

K860145 - RUBELLA ELISA TEST SYSTEM CATALOG NUMBE...

K860145 is the FDA 510(k) clearance for RUBELLA ELISA TEST SYSTEM CATALOG NUMBE... by Clinical Sciences, Inc.. It is a Class 2 Microbiology device (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

Submission Details

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
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.

Device Classification

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 63
Devices cleared under the same product code (LFX) and FDA review panel - the closest regulatory comparables to K860145.
AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200
K882475 · Amersham Corp. · Oct 1988
VIRGO(TM) RUBELLA IGG ELISA
K873088 · Electro-Nucleonics Laboratories, Inc. · Sep 1987
RUBELLA MICROASSAY
K864602 · Diamedix Corp. · Apr 1987
CORDOT R
K854618 · Cordis Corp. · May 1986
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
K853069 · Hybritech, Inc. · Jan 1986
RUBELLA IGG ANTIBODY ELISA TEST SYS
K841200 · Ortho Diagnostic Systems, Inc. · May 1984