Cleared Traditional

K961053 - SERAQUEST RUBELLA IGG

K961053 is the FDA 510(k) clearance for SERAQUEST RUBELLA IGG by Quest Intl., Inc.. It is a Class 2 Microbiology device (product code LFX) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K961053 · Quest Intl., Inc. · Microbiology device
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Sep 1996
Decision
170d
Days
Class 2
Risk

K961053 is an FDA 510(k) clearance for the SERAQUEST RUBELLA IGG. Classified as Enzyme Linked Immunoabsorbent Assay, Rubella (product code LFX), Class II - Special Controls.

Submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on September 4, 1996 after a review of 170 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 Quest Intl., Inc. devices

Submission Details

510(k) Number K961053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1996
Decision Date September 04, 1996
Days to Decision 170 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 102d · This submission: 170d
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 K961053.
INCSTAR RUBELLA IGG FAST ELISA ASSAY
K960358 · Incstar Corp. · Oct 1996
INCSTAR RUBELLA IGG ELISA ASSAY
K960367 · Incstar Corp. · Oct 1996
AXSYM RUBELLA IGG ANTIBODY ASSAY
K954045 · Abbott Laboratories · Sep 1996
IMX RUBELLA IGG
K951541 · Abbott Laboratories · Jul 1996
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
K954318 · Abbott Laboratories · May 1996
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
K951359 · Bayer Corp. · Apr 1996