Cleared Traditional

K842563 - SERATEST DNA DETERMINATION

K842563 is an FDA 510(k) clearance for SERATEST DNA DETERMINATION, manufactured by Seragen Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K842563 · Seragen Diagnostics, Inc. · Immunology device
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Oct 1984
Decision
115d
Days
Class 2
Risk

K842563 is an FDA 510(k) clearance for the SERATEST DNA DETERMINATION. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Seragen Diagnostics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 25, 1984 after a review of 115 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 Seragen Diagnostics, Inc. devices

FDA 510(k) Submission Details - K842563

510(k) Number K842563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1984
Decision Date October 25, 1984
Days to Decision 115 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 105d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKJ Device Classification - Class 2, Special Controls

Product Code LKJ Antinuclear Antibody, Antigen, 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 - LKJ Antinuclear Antibody, Antigen, Control

All 36
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K842563.
ANTINUCLEAR ANTIBODY (ANA) TEST (MOUSE LIVER SECT)
K883949 · Immco Diagnostics, Inc. · Oct 1988
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA)
K874115 · Sigma Diagnostics, Inc. · Nov 1987
KALLESTAD SM/RNP TEST REAGENT
K862313 · Kallestad Laboratories, Inc. · Aug 1986
LEAP LE TEST KIT
K842484 · Cooper Biomedical, Inc. · Jul 1984
ANA-CHECK
K831463 · Diagnostic Technology, Inc. · Jun 1983