Cleared Traditional

K051066 - THERATEST EL-ANA PROFILES

K051066 is the FDA 510(k) clearance for THERATEST EL-ANA PROFILES by Theratest Laboratories, Inc.. It is a Class 2 Immunology device (product code LKP) cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K051066 · Theratest Laboratories, Inc. · Immunology device
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Oct 2005
Decision
164d
Days
Class 2
Risk

K051066 is an FDA 510(k) clearance for the THERATEST EL-ANA PROFILES. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), Class II - Special Controls.

Submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on October 7, 2005 after a review of 164 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.

View all Theratest Laboratories, Inc. devices

Submission Details

510(k) Number K051066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2005
Decision Date October 07, 2005
Days to Decision 164 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 104d · This submission: 164d
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
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