Cleared Traditional

K872910 - IMMUNO/SLE

K872910 is the FDA 510(k) clearance for IMMUNO/SLE by Immunostics Co., Inc.. It is a Class 2 Immunology device (product code DHC) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K872910 · Immunostics Co., Inc. · Immunology device
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Aug 1987
Decision
19d
Days
Class 2
Risk

K872910 is an FDA 510(k) clearance for the IMMUNO/SLE. Classified as System, Test, Systemic Lupus Erythematosus (product code DHC), Class II - Special Controls.

Submitted by Immunostics Co., Inc. (Ocean, US). The FDA issued a Cleared decision on August 12, 1987 after a review of 19 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 Immunostics Co., Inc. devices

Submission Details

510(k) Number K872910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1987
Decision Date August 12, 1987
Days to Decision 19 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 104d · This submission: 19d
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
Devices cleared under the same product code (DHC) and FDA review panel - the closest regulatory comparables to K872910.
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