Cleared Traditional

K051066 - THERATEST EL-ANA PROFILES

K051066 is an FDA 510(k) clearance for THERATEST EL-ANA PROFILES, manufactured by Theratest Laboratories, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K051066

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 105d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKP Device Classification - Class 2, Special Controls

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 19
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K051066.
EliA SmDP Immunoassay
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K123593 · Inova Diagnostics, Inc. · Apr 2013
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
K024219 · Bio-Rad · Jan 2003
VARELISA SM ANTIBODIES
K000312 · Pharmacia & Upjohn Co. · Mar 2000
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K990625 · Cogent Diagnotics , Ltd. · Apr 1999