Cleared Traditional

K821385 - SERO/TEX LE TEST

K821385 is the FDA 510(k) clearance for SERO/TEX LE TEST by Texas Immunology, Inc.. It is a Class 2 Immunology device (product code DHC) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K821385 · Texas Immunology, Inc. · Immunology device
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May 1982
Decision
18d
Days
Class 2
Risk

K821385 is an FDA 510(k) clearance for the SERO/TEX LE TEST. Classified as System, Test, Systemic Lupus Erythematosus (product code DHC), Class II - Special Controls.

Submitted by Texas Immunology, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5820 - 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 Texas Immunology, Inc. devices

Submission Details

510(k) Number K821385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1982
Decision Date May 28, 1982
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 104d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHC System, Test, Systemic Lupus Erythematosus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5820
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 - DHC System, Test, Systemic Lupus Erythematosus

All 8
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