Cleared Traditional

K914454 - THE THERATEST EL-ANA PROFILES

K914454 is an FDA 510(k) clearance for THE THERATEST EL-ANA PROFILES, manufactured by Theratest Laboratories, Inc.. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K914454 · Theratest Laboratories, Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
228d
Days
Class 2
Risk

K914454 is an FDA 510(k) clearance for the THE THERATEST EL-ANA PROFILES. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Theratest Laboratories, Inc. (Chicago, US). The FDA issued a Cleared decision on May 22, 1992 after a review of 228 days - an extended review 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: 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.

FDA 510(k) Submission Details - K914454

510(k) Number K914454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1991
Decision Date May 22, 1992
Days to Decision 228 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 105d · This submission: 228d
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 49
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K914454.
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K921132 · Elias U.S.A., Inc. · Dec 1992
AUTOSTAT(TM) ANTI-DSNA
K913342 · Cogent Diagnotics , Ltd. · May 1992
ENCORE SCL-70
K920150 · Clark Laboratories, Inc. · Mar 1992
ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM
K914550 · Diagnostic Resources, Inc. · Feb 1992
K914454 · THE THERATEST EL-ANA PROFILES
Download PDF FDA Summary Theratest Laboratorie…