Cleared Traditional

K954106 - THERATEST LAB, INC., EL-ANASCR KIT

K954106 is an FDA 510(k) clearance for THERATEST LAB, manufactured by Theratest Laboratories, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K954106 · Theratest Laboratories, Inc. · Immunology device
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Nov 1995
Decision
105d
Days
Class 2
Risk

K954106 is an FDA 510(k) clearance for the THERATEST LAB, INC., EL-ANASCR KIT. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Theratest Laboratories, Inc. (Chicago, US). The FDA issued a Cleared decision on November 14, 1995 after a review of 105 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 Theratest Laboratories, Inc. devices

FDA 510(k) Submission Details - K954106

510(k) Number K954106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1995
Decision Date November 14, 1995
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 105d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

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 77
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K954106.
ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY
K954832 · Orgentec · Apr 1996
THERATEST KIT (MODIFICATION)
K955481 · Theratest Laboratories, Inc. · Mar 1996
QUANTA LITE SSDNA
K954380 · Inova Diagnostics, Inc. · Feb 1996
THERATEST EL-ANA PROFILES TEST SYSTEM
K950716 · Theratest Laboratories, Inc. · Sep 1995
MARDX ENA EIA TEST SYSTEM
K946218 · Hogan & Hartson · May 1995
MARDX MITOCHONDRIA EIA TEST SYSTEM
K950110 · Hogan & Hartson · May 1995