Cleared Traditional

K882475 - AMERLITE RUBELLA ANTIBODY ASSAY

K882475 is the FDA 510(k) clearance for AMERLITE RUBELLA ANTIBODY ASSAY by Amersham Corp.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K882475 · Amersham Corp. · Microbiology device
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Oct 1988
Decision
113d
Days
Class 2
Risk

K882475 is an FDA 510(k) clearance for the AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on October 6, 1988 after a review of 113 days - within the typical 510(k) review window.

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 Amersham Corp. devices

Submission Details

510(k) Number K882475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1988
Decision Date October 06, 1988
Days to Decision 113 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
11d slower than avg
Panel avg: 102d · This submission: 113d
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 K882475.
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
VIRGO(TM) RUBELLA IGG ELISA
K873088 · Electro-Nucleonics Laboratories, Inc. · Sep 1987
RUBELLA MICROASSAY
K864602 · Diamedix Corp. · Apr 1987
RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
K860145 · Clinical Sciences, Inc. · Jul 1986