Cleared Traditional

K024219 - LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115

K024219 is an FDA 510(k) clearance for LIQUICHEK ANTI-SM CONTROL, manufactured by Bio-Rad. The device is a Class 2 Immunology device with product code LKP cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K024219 · Bio-Rad · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
23d
Days
Class 2
Risk

K024219 is an FDA 510(k) clearance for the LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), Class II - Special Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on January 15, 2003 after a review of 23 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.

FDA 510(k) Submission Details - K024219

510(k) Number K024219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date January 15, 2003
Days to Decision 23 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
82d faster than avg
Panel avg: 105d · This submission: 23d
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 27
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K024219.
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
K123593 · Inova Diagnostics, Inc. · Apr 2013
THERATEST EL-ANA PROFILES
K051066 · Theratest Laboratories, Inc. · Oct 2005
VARELISA SM ANTIBODIES, MODEL 18296
K042629 · Sweden Diagnostics (Germany) GmbH · Dec 2004
FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
K013263 · Fred Hutchinson Cancer Research Center · Jul 2002
RHIGENE MESACUP2 TEST- SM
K000755 · Rhigene, Inc. · May 2000
VARELISA SM ANTIBODIES
K000312 · Pharmacia & Upjohn Co. · Mar 2000
K024219 · LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
Download PDF FDA Summary Bio-Rad