Cleared Traditional

K844743 - SERATEST ENA(RNP/SM) DETERMINATION

K844743 is the FDA 510(k) clearance for SERATEST ENA(RNP/SM) DETERMINATION by Seragen Diagnostics, Inc.. It is a Class 2 Immunology device (product code LLL) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K844743 · Seragen Diagnostics, Inc. · Immunology device
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Feb 1985
Decision
61d
Days
Class 2
Risk

K844743 is an FDA 510(k) clearance for the SERATEST ENA(RNP/SM) DETERMINATION. Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Seragen Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 4, 1985 after a review of 61 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 Seragen Diagnostics, Inc. devices

Submission Details

510(k) Number K844743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1984
Decision Date February 04, 1985
Days to Decision 61 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 104d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLL Extractable Antinuclear 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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 118
Devices cleared under the same product code (LLL) and FDA review panel - the closest regulatory comparables to K844743.
SM-RNP AUTOANTIBODY TEST SYSTEM
K860428 · Immuno Concepts, Inc. · May 1986
SS-A/SS-B AUTOANTIBODY TEST SYSTEM
K860644 · Immuno Concepts, Inc. · Mar 1986
PHYSIO GAS ANALYZER
K843423 · Research Medical, Inc. · Feb 1985
ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY
K843978 · Behring Diagnostics, Inc. · Dec 1984
EXTRACTABLE NUCLEAR ANTIGEN ASSAY
K840221 · Zeus Scientific, Inc. · May 1984
ENA TEST KIT SM & RNP AUTO ANTIBODY
K831036 · Calbiochem-Behring Corp. · Apr 1983