Cleared Traditional

K980810 - SERAQUEST ANTI-SSA

K980810 is the FDA 510(k) clearance for SERAQUEST ANTI-SSA by Quest Intl., Inc.. It is a Class 2 Immunology device (product code LJM) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K980810 · Quest Intl., Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
70d
Days
Class 2
Risk

K980810 is an FDA 510(k) clearance for the SERAQUEST ANTI-SSA. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on May 12, 1998 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - the FDA immunology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quest Intl., Inc. devices

Submission Details

510(k) Number K980810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1998
Decision Date May 12, 1998
Days to Decision 70 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 104d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 Immunology devices follow this clearance model.

Regulatory Peers - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 39
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