Cleared Traditional

K142705 - LeadCare Plus Blood Lead Testing System (FDA 510(k) Clearance)

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

K142705 · Magellan Diagnostics · Toxicology device
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Optimized for regulatory review, auditing and printing
Jul 2015
Decision
288d
Days
Class 2
Risk

K142705 is an FDA 510(k) clearance for the LeadCare Plus Blood Lead Testing System. Classified as Lead, Atomic Absorption (product code DOF), Class II - Special Controls.

Submitted by Magellan Diagnostics (N. Billerica, US). The FDA issued a Cleared decision on July 7, 2015 after a review of 288 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3550 - 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.

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Submission Details

510(k) Number K142705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2014
Decision Date July 07, 2015
Days to Decision 288 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 87d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DOF Lead, Atomic Absorption
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3550
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.