Cleared Traditional

K024151 - EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P

K024151 is an FDA 510(k) clearance for EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P, manufactured by Theratest Laboratories, Inc.. The device is a Class 2 Immunology device with product code MQA cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K024151 · Theratest Laboratories, Inc. · Immunology device
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Feb 2003
Decision
62d
Days
Class 2
Risk

K024151 is an FDA 510(k) clearance for the EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P. Classified as Anti-ribosomal P Antibodies (product code MQA), Class II - Special Controls.

Submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on February 6, 2003 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Theratest Laboratories, Inc. devices

FDA 510(k) Submission Details - K024151

510(k) Number K024151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2002
Decision Date February 06, 2003
Days to Decision 62 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
43d faster than avg
Panel avg: 105d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQA Device Classification - Class 2, Special Controls

Product Code MQA Anti-ribosomal P Antibodies
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.