Cleared Traditional

K961053 - SERAQUEST RUBELLA IGG

K961053 is an FDA 510(k) clearance for SERAQUEST RUBELLA IGG, manufactured by Quest Intl., Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K961053

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
Combination Product No
PCCP Authorized No
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.

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 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