Cleared Traditional

K980540 - SERAQUEST ANTI-SM

K980540 is the FDA 510(k) clearance for SERAQUEST ANTI-SM by Quest Intl., Inc.. It is a Class 2 Immunology device (product code LKP) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K980540 · Quest Intl., Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Jun 1998
Decision
123d
Days
Class 2
Risk

K980540 is an FDA 510(k) clearance for the SERAQUEST ANTI-SM. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), Class II - Special Controls.

Submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on June 15, 1998 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quest Intl., Inc. devices

Submission Details

510(k) Number K980540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1998
Decision Date June 15, 1998
Days to Decision 123 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
19d slower than avg
Panel avg: 104d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKP Anti-sm Antibody, Antigen And Control
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 - LKP Anti-sm Antibody, Antigen And Control

All 9
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K980540.
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K841930 · Diagnostic Chemicals, Ltd. (Usa) · Jun 1984