Cleared Traditional

K142705 - LeadCare Plus Blood Lead Testing System

K142705 is an FDA 510(k) clearance for LeadCare Plus Blood Lead Testing System, manufactured by Magellan Diagnostics. The device is a Class 2 Toxicology device with product code DOF cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K142705 · Magellan Diagnostics · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K142705

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
Combination Product No
PCCP Authorized No
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.

DOF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DOF Lead, Atomic Absorption

Devices cleared under the same product code (DOF) and FDA review panel - the closest regulatory comparables to K142705.
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
K123563 · Magellan Diagnostics · Aug 2013
LEADCARE II BLOOD LEAD TESTING SYSTEM
K052549 · Esa Biosciences, Inc. · Oct 2005
LEADCARE BLOOD LEAD TESTING SYSTEM
K971640 · Esa, Inc. · Sep 1997
ATOMSPEC GF BLOOD LEAD WORKSTATION
K936060 · Thermo Jarrell Ash Corp.Div.Thermo Inst. · Sep 1994
STAT/PB REAGENT
K843839 · Tri-Tech, Inc. · Jan 1985
K142705 · LeadCare Plus Blood Lead Testing System
Download PDF FDA Summary Magellan Diagnostics