Cleared Traditional

K914853 - ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT

K914853 is an FDA 510(k) clearance for ANTINUCLEAR ANTIBODY (ANA) SCREENING TE..., manufactured by Reads Medical Products, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K914853 · Reads Medical Products, Inc. · Immunology device
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Jan 1992
Decision
79d
Days
Class 2
Risk

K914853 is an FDA 510(k) clearance for the ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Reads Medical Products, Inc. (Westminster, US). The FDA issued a Cleared decision on January 15, 1992 after a review of 79 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 Reads Medical Products, Inc. devices

FDA 510(k) Submission Details - K914853

510(k) Number K914853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1991
Decision Date January 15, 1992
Days to Decision 79 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 105d · This submission: 79d
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 80
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