Cleared Traditional

TURBOX THEOPHYLLINE ASSAY (K882570) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K882570 · Unipath , Ltd. · Toxicology device
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Nov 1988
Decision
141d
Days
Class 2
Risk

K882570 is an FDA 510(k) clearance for the TURBOX THEOPHYLLINE ASSAY. Classified as Fluorescent Immunoassay, Theophylline (product code LER), Class II - Special Controls.

Submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on November 10, 1988 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3880 - the FDA toxicology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Unipath , Ltd. devices

Submission Details

510(k) Number K882570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1988
Decision Date November 10, 1988
Days to Decision 141 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 87d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LER Fluorescent Immunoassay, Theophylline
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3880
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 Toxicology devices follow this clearance model.